Non Small Cell Lung Cancer
Conditions
Brief summary
This study has two parts: dose escalation and dose expansion. The primary objectives are: * For Dose Escalation, to assess the safety and tolerability of DS-1205c when combined with gefitinib in the study population and to determine the recommended dose for expansion of DS-1205c when combined with gefitinib in the study population * For Dose Expansion, to assess the safety and tolerability of DS-1205c when combined with gefitinib in the study population. In Dose Escalation, after a 7-day run in period (Cycle 0), there will be 21-day cycles (Cycle 1 onward). In Dose Expansion, there will be 21-day cycles. The number of treatment cycles is not fixed in this study. Participants will continue study treatment for 36 months unless they decide not to (withdraw consent), their disease gets worse \[progressive disease (PD)\], or side effects become unacceptable (unacceptable toxicity).
Interventions
DRUGDS-1205c
DS-1205c 200 mg capsule for oral administration
DRUGGefitinib
Gefitinib 250 mg tablet for oral administration
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has histologically or cytologically documented adenocarcinoma NSCLC 2. Has locally advanced or metastatic NSCLC, not amenable to curative surgery or radiation 3. Has acquired resistance to EGFR tyrosine kinase inhibitor (TKI) according to the Jackman criteria (PMID: 19949011): 1. Historical confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) OR 2. Has experienced clinical benefit from an EGFR TKI, followed by systemic progression \[Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) or World Health Organization (WHO)\] while on continuous treatment with an EGFR TKI 4. Is currently receiving and able to interrupt gefitinib or discontinue erlotinib, afatinib, or osimertinib 5. Has been receiving gefitinib, erlotinib, afatinib, or osimertinib for at least 6 weeks with well-controlled related toxicities less than Grade 3 in severity at the time of screening period; participants who have been receiving gefitinib must be taking gefitinib at a dose of 250 mg/day 6. Has radiological documentation of disease progression while receiving continuous treatment with gefitinib, erlotinib, afatinib, or osimertinib 7. Has at least one measurable lesion per RECIST version 1.1 8. Is willing to provide archival tumor tissue from a biopsy performed after progression during treatment with gefitinib, erlotinib, afatinib, or osimertinib OR has at least one lesion, not previously irradiated, amenable to core biopsy and is willing to undergo screening tumor biopsy 9. Demonstrates absence of EGFR T790M mutation in tumor tissue since progression during gefitinib, erlotinib, afatinib, or osimertinib treatment 10. Has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1, with no deterioration over the previous 2 weeks
Exclusion criteria
1. Has any evidence of small cell histology, or combined small cell and non-small cell histology, in original tumor biopsy or in screening biopsy performed since progression 2. Has previously documented evidence of anaplastic lymphoma kinase (ALK) fusion, ROS proto-oncogene 1 (ROS1) fusion, BRAF V600E mutation, rearranged during transfection (RET) rearrangement, human epidermal growth factor receptor 2 (HER2) mutation, or MET exon 14 skipping mutation - no new testing for these genomic alterations is required for Screening 3. Has received treatment with any of the following: 1. Any cytotoxic chemotherapy, immune checkpoint inhibitor therapy, investigational agent or other anticancer drug(s) from a previous cancer treatment regimen or clinical study (other than EGFR TKI), within 14 days of the first dose of study treatment 2. Immune checkpoint inhibitor therapy within 30 days of first dose of study treatment 3. Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment 4. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks, or palliative radiation therapy within 2 weeks of the first dose of study drug treatment 4. Has history of other active malignancy within 3 years prior to enrollment, except: 1. Adequately treated non-melanoma skin cancer OR 2. Superficial bladder tumors (Tumor stage a \[Ta\], Tumor stage is \[Tis\], Tumor stage 1 \[T1\]) OR 3. Curatively treated in situ disease OR 4. Low-risk non-metastatic prostate cancer (with Gleason score \< 7 on antiandrogen therapy) 5. Has spinal cord compression or clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms - Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment (1 week for stereotactic radiotherapy). 6. Has retinal disease in the eye that is not due to neovascular age-related macular degeneration (nAMD; eg, significant diabetic retinopathy, glaucomatous retinal atrophy, retinal detachment) 7. Has history of myocardial infarction within the past 6 months 8. Has symptomatic congestive heart failure \[New York Heart Association (NYHA) Classes II-IV\], unstable angina, or cardiac arrhythmia requiring antiarrhythmic treatment 9. Has left ventricular ejection fraction (LVEF) \< 45% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan 10. Has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, eg, complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval \> 250 milliseconds (ms) 11. Has a mean corrected QT interval using Fridericia's correction (QTcF) prolongation \>470 ms for females and \>450 ms for males in three successive Screening measurements 12. Unable or unwilling to discontinue concomitant use of drugs that are known to prolong the QT interval 13. Has any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as congenital long QT. syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives 14. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroid treatment, has current ILD/pneumonitis, or has suspected ILD/pneumonitis which cannot be ruled out by imaging at screening 15. Has history of pancreatitis within the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLTs) Following Administration With DS-1205c in Combination With Gefitinib | Cycle 0 Day 1 (7-day cycle) to Cycle 1 Day 21 (each cycle is 21 days) | A dose-limiting toxicity (DLT) was defined as any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes that occurs during the DLT-evaluation period (Cycle 0 Day 1 to Cycle 1 Day 21 of Dose Escalation) and is Grade 3 or above, according to NCI-CTCAE version 5.0. |
| Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 1, 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year | An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A treatment-emergent adverse event (TEAE) was defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiating the study drug until 37 days after last dose of the study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Screening; Cycle 0 (7-day cycle); Cycle 1 and beyond (21-day cycles), Every 6 weeks (± 7 days) in the first 24 weeks after Day 1 of Cycle 1, and every 12 weeks (± 7 days) thereafter; and end-of-treatment, 30 days after last dose, up to 1 year | Progression-free survival (PFS) was defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of radiographic PD or death due to any cause. As per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions. |
| Overall Survival in Participants Following Administration of DS-1205c in Combination With Gefitinib | Screening; Cycle 0 (7-day cycle); Cycle 1 and beyond (21-day cycles), Every 6 weeks (± 7 days) in the first 24 weeks after Day 1 of Cycle 1, and every 12 weeks (± 7 days) thereafter; and end-of-treatment, 30 days after last dose, up to 1 year | Overall Survival (OS) was defined as the time from the date of first dose to the date of death from any cause. |
| Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 0 (7-day cycle; DS-1205c alone), Days 1 and 7; Predose of Cycle 1 (21-day cycle), Day 1 (DS-1205c + gefitinib); Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 2 (21-day cycle; DS-1205c + gefitinib), Day 1 | Blood samples for pharmacokinetic (PK) analyses of DS-1205a were obtained at specified time points. Plasma concentrations of DS-1205a were measured using validated assays and non-compartmental analysis. |
| Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Screening; Cycle 0 (7-day cycle); Cycle 1 and beyond (21-day cycles), Every 6 weeks (± 7 days) in the first 24 weeks after Day 1 of Cycle 1, and every 12 weeks (± 7 days) thereafter; and end-of-treatment, 30 days after last dose, up to 1 year | Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Objective response rate was calculated as the number of participants with best objective response (CR + PR) determined by Investigator assessment based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1\]. |
| Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 0 (7-day cycle; DS-1205c alone), Days 1 and 7; Predose of Cycle 1 (21-day cycle), Day 1 (DS-1205c + gefitinib); Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 2 (21-day cycle; DS-1205c + gefitinib), Day 1 | Blood samples for pharmacokinetic (PK) analyses of DS-1205a were obtained at specified time points. Plasma concentrations of DS-1205a were measured using validated assays and non-compartmental analysis. Area under the plasma concentration curve from time 0 to 8 hours (AUC8h), area under the plasma concentration-time curve from time 0 to 10 hours (AUC10h), and area under the plasma concentration-time curve during a dosing interval (AUCtau) were assessed. |
| Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 0 (7-day cycle; DS-1205c alone), Days 1 and 7; Predose of Cycle 1 (21-day cycle), Day 1 (DS-1205c + gefitinib); Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 2 (21-day cycle; DS-1205c + gefitinib), Day 1 | Blood samples for pharmacokinetic (PK) analyses of DS-1205a were obtained at specified time points. Plasma concentrations of DS-1205a were measured using validated assays and non-compartmental analysis. |
| Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 0 (7-day cycle; DS-1205c alone), Days 1 and 7; Predose of Cycle 1 (21-day cycle), Day 1 (DS-1205c + gefitinib); Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 2 (21-day cycle; DS-1205c + gefitinib), Day 1 | Blood samples for pharmacokinetic (PK) analyses of DS-1205a were obtained at specified time points. Plasma concentrations of DS-1205a were measured using validated assays and non-compartmental analysis. |
| Disease Control Rate Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Screening; Cycle 0 (7-day cycle); Cycle 1 and beyond (21-day cycles), Every 6 weeks (± 7 days) in the first 24 weeks after Day 1 of Cycle 1, and every 12 weeks (± 7 days) thereafter; and end-of-treatment, 30 days after last dose, up to 1 year | Disease control rate (DCR) was defined number of participants with CR+PR+SD objective response. As per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. |
Countries
Japan
Participant flow
Recruitment details
A total of 20 participants were enrolled and treated in this clinical trial from 21 Sep 2018 to 29 Jun 2020 at 8 clinic sites in Japan.
Pre-assignment details
Dose Escalation started with a DS-1205c monotherapy 7-day run-in period (Cycle 0), followed by combination treatment (DS-1205c + gefitinib). Participants received a final dose of gefitinib, erlotinib, afatinib, dacomitinib, or osimertinib on Cycle 0, Day -1. During the run-in period, participants received DS-1205c orally twice daily (BID). On Cycle 1, Day 1, DS-1205c was administered orally BID in combination with gefitinib 250 mg administered orally once daily (21-day cycles).
Participants by arm
| Arm | Count |
|---|---|
| DS-1205c 200 mg + Gefitinib Participants who received DS-1205c 200 mg twice daily (BID) in combination with daily 250 mg oral dose of gefitinib. | 5 |
| DS-1205c 400 mg + Gefitinib Participants who received DS-1205c 400 mg twice daily (BID) in combination with daily 250 mg oral dose of gefitinib. | 4 |
| DS-1205c 800 mg + Gefitinib Participants who received DS-1205c 800 mg twice daily (BID) in combination with daily 250 mg oral dose of gefitinib. | 6 |
| DS-1205c 1000 mg + Gefitinib Participants who received DS-1205c 1000 mg twice daily (BID) in combination with daily 250 mg oral dose of gefitinib. | 1 |
| DS-1205c 1200 mg + Gefitinib Participants who received DS-1205c 1200 mg twice daily (BID) in combination with daily 250 mg oral dose of gefitinib. | 4 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Clinical progression | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Participant withdrawal from study treatment | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Progressive disease as per RECIST v1.1 | 5 | 4 | 5 | 1 | 2 |
Baseline characteristics
| Characteristic | DS-1205c 400 mg + Gefitinib | DS-1205c 800 mg + Gefitinib | DS-1205c 1000 mg + Gefitinib | DS-1205c 1200 mg + Gefitinib | DS-1205c 200 mg + Gefitinib | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 5 Participants | 0 Participants | 2 Participants | 3 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 6 Participants |
| Age, Continuous | 69.5 years | 70 years | 41 years | 66 years | 67 years | 68.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 1 Participants | 4 Participants | 5 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 4 participants | 6 participants | 1 participants | 4 participants | 5 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 1 Participants | 3 Participants | 3 Participants | 16 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 5 | 1 / 4 | 1 / 6 | 1 / 1 | 0 / 4 |
| other Total, other adverse events | 5 / 5 | 4 / 4 | 6 / 6 | 0 / 1 | 4 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 | 0 / 6 | 0 / 1 | 0 / 4 |
Outcome results
Primary
Number of Participants With Dose-limiting Toxicities (DLTs) Following Administration With DS-1205c in Combination With Gefitinib
A dose-limiting toxicity (DLT) was defined as any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes that occurs during the DLT-evaluation period (Cycle 0 Day 1 to Cycle 1 Day 21 of Dose Escalation) and is Grade 3 or above, according to NCI-CTCAE version 5.0.
Time frame: Cycle 0 Day 1 (7-day cycle) to Cycle 1 Day 21 (each cycle is 21 days)
Population: Dose-limiting toxicities (DLTs) were assessed in the DLT-Evaluable Set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DS-1205c 200 mg + Gefitinib | Number of Participants With Dose-limiting Toxicities (DLTs) Following Administration With DS-1205c in Combination With Gefitinib | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Dose-limiting Toxicities (DLTs) Following Administration With DS-1205c in Combination With Gefitinib | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Dose-limiting Toxicities (DLTs) Following Administration With DS-1205c in Combination With Gefitinib | 1 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Dose-limiting Toxicities (DLTs) Following Administration With DS-1205c in Combination With Gefitinib | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Dose-limiting Toxicities (DLTs) Following Administration With DS-1205c in Combination With Gefitinib | 1 Participants |
Primary
Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A treatment-emergent adverse event (TEAE) was defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiating the study drug until 37 days after last dose of the study drug.
Time frame: Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 1, 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year
Population: Adverse events (AEs) were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Injury, Poisoning and Procedural Complications | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Vertigo | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Ear and Labyrinth Disorders | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Eye disorder | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Metabolism and Nutrition Disorders | 3 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Amylase increased | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dry eye | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Conjunctival haemorrhage | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Eye Disorders | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Decreased appetite | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neutrophil count decreased | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Vagus nerve disorder | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hypoaesthesia | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Nervous System Disorders | 2 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hypertriglyceridaemia | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Weight decreased | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hyperuricaemia | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Electrocardiogram QT prolonged | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Any TEAE | 5 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Nausea | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | White blood cell count decreased | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Alanine aminotransferase increased | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Aspartate aminotransferase increased | 2 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Infections and Infestations | 2 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neutropenia | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Investigations | 3 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Pain | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Upper respiratory tract infection | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Lipase increased | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Malaise | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Pyrexia | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | General Disorders and Administration Site Conditions | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Nasopharyngitis | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Abdominal pain upper | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neck pain | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Musculoskeletal and Connective Tissue Disorders | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dry skin | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Paronychia | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Rash | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Pruritus | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dermatitis acneiform | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Rash maculo-papular | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neoplasms Benign, Malignant, and Unspecified (including Cysts and Polyps) | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Blood creatinine phosphokinase increased | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Skin and Subcutaneous Tissue Disorders | 3 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hepatic function abnormal | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hepatobiliary Disorders | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Tumour pain | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Blood alkaline phosphatase increased | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Abdominal pain lower | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Stomatitis | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dyspepsia | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Blood and Lymphatic System Disorders | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Skin hyperpigmentation | 1 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Constipation | 2 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Vomiting | 2 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Diarrhoea | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Anaemia | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Fall | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Gastrointestinal Disorders | 4 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Cough | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Respiratory, Thoracic and Mediastinal Disorders | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Paronychia | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Nausea | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Skin hyperpigmentation | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | General Disorders and Administration Site Conditions | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Aspartate aminotransferase increased | 1 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Any TEAE | 4 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Infections and Infestations | 1 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Upper respiratory tract infection | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Nasopharyngitis | 1 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neoplasms Benign, Malignant, and Unspecified (including Cysts and Polyps) | 1 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Tumour pain | 1 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Blood and Lymphatic System Disorders | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Anaemia | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neutropenia | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Metabolism and Nutrition Disorders | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Decreased appetite | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hypertriglyceridaemia | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hyperuricaemia | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Nervous System Disorders | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hypoaesthesia | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Vagus nerve disorder | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Eye Disorders | 2 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Conjunctival haemorrhage | 1 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dry eye | 1 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Eye disorder | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Ear and Labyrinth Disorders | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Vertigo | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Respiratory, Thoracic and Mediastinal Disorders | 1 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Cough | 1 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Gastrointestinal Disorders | 3 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Diarrhoea | 3 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Vomiting | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Constipation | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dyspepsia | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Stomatitis | 1 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Abdominal pain lower | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Abdominal pain upper | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hepatobiliary Disorders | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hepatic function abnormal | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Skin and Subcutaneous Tissue Disorders | 3 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Rash maculo-papular | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dermatitis acneiform | 3 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Pruritus | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Rash | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dry skin | 1 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Musculoskeletal and Connective Tissue Disorders | 1 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neck pain | 1 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Pyrexia | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Malaise | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Pain | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Investigations | 2 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Alanine aminotransferase increased | 1 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | White blood cell count decreased | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Electrocardiogram QT prolonged | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neutrophil count decreased | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Amylase increased | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Blood alkaline phosphatase increased | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Blood creatinine phosphokinase increased | 1 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Lipase increased | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Weight decreased | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Injury, Poisoning and Procedural Complications | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Fall | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | White blood cell count decreased | 3 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neutropenia | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Vertigo | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Investigations | 4 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Respiratory, Thoracic and Mediastinal Disorders | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Cough | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Anaemia | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Amylase increased | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Diarrhoea | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Nausea | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Vomiting | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Blood and Lymphatic System Disorders | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Constipation | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dyspepsia | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Blood alkaline phosphatase increased | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Stomatitis | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Tumour pain | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Abdominal pain lower | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Abdominal pain upper | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hepatobiliary Disorders | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Gastrointestinal Disorders | 3 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hepatic function abnormal | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neoplasms Benign, Malignant, and Unspecified (including Cysts and Polyps) | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Blood creatinine phosphokinase increased | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Skin and Subcutaneous Tissue Disorders | 5 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Rash maculo-papular | 3 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dermatitis acneiform | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Paronychia | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Pruritus | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Rash | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Lipase increased | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dry skin | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Skin hyperpigmentation | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Musculoskeletal and Connective Tissue Disorders | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Nasopharyngitis | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neck pain | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | General Disorders and Administration Site Conditions | 2 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Pyrexia | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Upper respiratory tract infection | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Fall | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Malaise | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Weight decreased | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Pain | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Infections and Infestations | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Aspartate aminotransferase increased | 2 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Alanine aminotransferase increased | 2 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Any TEAE | 6 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hypertriglyceridaemia | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hyperuricaemia | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Nervous System Disorders | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Electrocardiogram QT prolonged | 2 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hypoaesthesia | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Decreased appetite | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Vagus nerve disorder | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Eye Disorders | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Conjunctival haemorrhage | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Metabolism and Nutrition Disorders | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Injury, Poisoning and Procedural Complications | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dry eye | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neutrophil count decreased | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Eye disorder | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Ear and Labyrinth Disorders | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Rash maculo-papular | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Nasopharyngitis | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Lipase increased | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hyperuricaemia | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Weight decreased | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Vertigo | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Musculoskeletal and Connective Tissue Disorders | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Pruritus | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dry eye | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Paronychia | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Respiratory, Thoracic and Mediastinal Disorders | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Electrocardiogram QT prolonged | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Anaemia | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Injury, Poisoning and Procedural Complications | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Metabolism and Nutrition Disorders | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Cough | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neck pain | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Aspartate aminotransferase increased | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Infections and Infestations | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Gastrointestinal Disorders | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Blood creatinine phosphokinase increased | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Decreased appetite | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Amylase increased | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Any TEAE | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | General Disorders and Administration Site Conditions | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Nausea | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Rash | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Blood and Lymphatic System Disorders | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Upper respiratory tract infection | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Investigations | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Vomiting | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neutrophil count decreased | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Alanine aminotransferase increased | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Skin and Subcutaneous Tissue Disorders | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Vagus nerve disorder | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Constipation | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Pyrexia | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dermatitis acneiform | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Eye disorder | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neutropenia | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dyspepsia | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Fall | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Tumour pain | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Diarrhoea | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Ear and Labyrinth Disorders | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Stomatitis | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dry skin | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | White blood cell count decreased | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Blood alkaline phosphatase increased | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hypertriglyceridaemia | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Abdominal pain lower | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Malaise | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Abdominal pain upper | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Nervous System Disorders | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hypoaesthesia | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Skin hyperpigmentation | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Conjunctival haemorrhage | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hepatobiliary Disorders | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Eye Disorders | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neoplasms Benign, Malignant, and Unspecified (including Cysts and Polyps) | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Pain | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hepatic function abnormal | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Conjunctival haemorrhage | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hepatic function abnormal | 1 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hyperuricaemia | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Decreased appetite | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Skin and Subcutaneous Tissue Disorders | 3 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Paronychia | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Rash maculo-papular | 2 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Blood creatinine phosphokinase increased | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dermatitis acneiform | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Abdominal pain lower | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Nervous System Disorders | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Pruritus | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Fall | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Rash | 1 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Nasopharyngitis | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Eye disorder | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dry skin | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Skin hyperpigmentation | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hypoaesthesia | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Musculoskeletal and Connective Tissue Disorders | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Lipase increased | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neck pain | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Upper respiratory tract infection | 1 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dry eye | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | General Disorders and Administration Site Conditions | 1 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Diarrhoea | 1 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Pyrexia | 1 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Vagus nerve disorder | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Metabolism and Nutrition Disorders | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Electrocardiogram QT prolonged | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Malaise | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Infections and Infestations | 1 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neutropenia | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Pain | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Ear and Labyrinth Disorders | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Eye Disorders | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neutrophil count decreased | 1 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Vertigo | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Anaemia | 1 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Investigations | 2 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Any TEAE | 4 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Respiratory, Thoracic and Mediastinal Disorders | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Cough | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Aspartate aminotransferase increased | 2 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Gastrointestinal Disorders | 3 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Blood and Lymphatic System Disorders | 1 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Weight decreased | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Nausea | 2 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Amylase increased | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Vomiting | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Alanine aminotransferase increased | 2 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Constipation | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Tumour pain | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Injury, Poisoning and Procedural Complications | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Dyspepsia | 1 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Stomatitis | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Blood alkaline phosphatase increased | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Abdominal pain upper | 1 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Neoplasms Benign, Malignant, and Unspecified (including Cysts and Polyps) | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hypertriglyceridaemia | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | Hepatobiliary Disorders | 1 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Treatment-emergent Adverse Events Occurring in Participants Following Administration With DS-1205c in Combination With Gefitinib | White blood cell count decreased | 1 Participants |
Secondary
Disease Control Rate Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib
Disease control rate (DCR) was defined number of participants with CR+PR+SD objective response. As per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Time frame: Screening; Cycle 0 (7-day cycle); Cycle 1 and beyond (21-day cycles), Every 6 weeks (± 7 days) in the first 24 weeks after Day 1 of Cycle 1, and every 12 weeks (± 7 days) thereafter; and end-of-treatment, 30 days after last dose, up to 1 year
Population: Disease control rate (DCR) was assessed in the Full Analysis Set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DS-1205c 200 mg + Gefitinib | Disease Control Rate Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | 2 Participants |
| DS-1205c 400 mg + Gefitinib | Disease Control Rate Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Disease Control Rate Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | 1 Participants |
| DS-1205c 1000 mg + Gefitinib | Disease Control Rate Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Disease Control Rate Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | 1 Participants |
Secondary
Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib
Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Objective response rate was calculated as the number of participants with best objective response (CR + PR) determined by Investigator assessment based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1\].
Time frame: Screening; Cycle 0 (7-day cycle); Cycle 1 and beyond (21-day cycles), Every 6 weeks (± 7 days) in the first 24 weeks after Day 1 of Cycle 1, and every 12 weeks (± 7 days) thereafter; and end-of-treatment, 30 days after last dose, up to 1 year
Population: Best overall response was assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DS-1205c 200 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Complete response (CR) | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Progressive disease (PD) | 3 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Partial response (PR) | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Stable disease (SD) | 2 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Non-Evaluable (NE) | 0 Participants |
| DS-1205c 200 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Objective response rate (CR+PR) | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Complete response (CR) | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Non-Evaluable (NE) | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Stable disease (SD) | 1 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Objective response rate (CR+PR) | 0 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Progressive disease (PD) | 3 Participants |
| DS-1205c 400 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Partial response (PR) | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Progressive disease (PD) | 5 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Complete response (CR) | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Partial response (PR) | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Objective response rate (CR+PR) | 0 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Stable disease (SD) | 1 Participants |
| DS-1205c 800 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Non-Evaluable (NE) | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Stable disease (SD) | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Progressive disease (PD) | 1 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Objective response rate (CR+PR) | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Partial response (PR) | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Complete response (CR) | 0 Participants |
| DS-1205c 1000 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Non-Evaluable (NE) | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Objective response rate (CR+PR) | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Complete response (CR) | 0 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Progressive disease (PD) | 2 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Stable disease (SD) | 1 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Non-Evaluable (NE) | 1 Participants |
| DS-1205c 1200 mg + Gefitinib | Number of Participants With Best Overall Response With Confirmation as Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | Partial response (PR) | 0 Participants |
Secondary
Overall Survival in Participants Following Administration of DS-1205c in Combination With Gefitinib
Overall Survival (OS) was defined as the time from the date of first dose to the date of death from any cause.
Time frame: Screening; Cycle 0 (7-day cycle); Cycle 1 and beyond (21-day cycles), Every 6 weeks (± 7 days) in the first 24 weeks after Day 1 of Cycle 1, and every 12 weeks (± 7 days) thereafter; and end-of-treatment, 30 days after last dose, up to 1 year
Population: Overall survival (OS) was assessed in the Full Analysis Set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DS-1205c 200 mg + Gefitinib | Overall Survival in Participants Following Administration of DS-1205c in Combination With Gefitinib | 27.4 weeks |
| DS-1205c 400 mg + Gefitinib | Overall Survival in Participants Following Administration of DS-1205c in Combination With Gefitinib | NA weeks |
| DS-1205c 800 mg + Gefitinib | Overall Survival in Participants Following Administration of DS-1205c in Combination With Gefitinib | NA weeks |
| DS-1205c 1000 mg + Gefitinib | Overall Survival in Participants Following Administration of DS-1205c in Combination With Gefitinib | 35.4 weeks |
| DS-1205c 1200 mg + Gefitinib | Overall Survival in Participants Following Administration of DS-1205c in Combination With Gefitinib | NA weeks |
Secondary
Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib
Blood samples for pharmacokinetic (PK) analyses of DS-1205a were obtained at specified time points. Plasma concentrations of DS-1205a were measured using validated assays and non-compartmental analysis. Area under the plasma concentration curve from time 0 to 8 hours (AUC8h), area under the plasma concentration-time curve from time 0 to 10 hours (AUC10h), and area under the plasma concentration-time curve during a dosing interval (AUCtau) were assessed.
Time frame: Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 0 (7-day cycle; DS-1205c alone), Days 1 and 7; Predose of Cycle 1 (21-day cycle), Day 1 (DS-1205c + gefitinib); Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 2 (21-day cycle; DS-1205c + gefitinib), Day 1
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1: AUC8h | 2980 ng*h/mL | Standard Deviation 165 |
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7: AUC10h | 3760 ng*h/mL | Standard Deviation 136 |
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1: AUCtau | 4290 ng*h/mL | Standard Deviation 224 |
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1: AUC10h | 3780 ng*h/mL | Standard Deviation 536 |
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7: AUCtau | 4430 ng*h/mL | Standard Deviation 173 |
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1: AUCtau | 4520 ng*h/mL | Standard Deviation 649 |
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 1: AUC10h | 1710 ng*h/mL | Standard Deviation 170 |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1: AUC10h | 5290 ng*h/mL | Standard Deviation 1230 |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1: AUC8h | 5670 ng*h/mL | Standard Deviation 1360 |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 1: AUC10h | 2800 ng*h/mL | Standard Deviation 675 |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1: AUCtau | 6300 ng*h/mL | Standard Deviation 1460 |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1: AUCtau | 7930 ng*h/mL | Standard Deviation 1600 |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7: AUC10h | 5990 ng*h/mL | Standard Deviation 945 |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7: AUCtau | 7000 ng*h/mL | Standard Deviation 1010 |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7: AUC10h | 8120 ng*h/mL | Standard Deviation 2520 |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1: AUCtau | 8530 ng*h/mL | Standard Deviation 2640 |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 1: AUC10h | 3860 ng*h/mL | Standard Deviation 1730 |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7: AUCtau | 9490 ng*h/mL | Standard Deviation 2860 |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1: AUC8h | 6820 ng*h/mL | Standard Deviation 2590 |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1: AUCtau | 9820 ng*h/mL | Standard Deviation 3640 |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1: AUC10h | 7350 ng*h/mL | Standard Deviation 2160 |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7: AUCtau | 5490 ng*h/mL | Standard Deviation 0 |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1: AUC10h | 5030 ng*h/mL | Standard Deviation 0 |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1: AUCtau | 6060 ng*h/mL | Standard Deviation 0 |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 1: AUC10h | 2440 ng*h/mL | Standard Deviation 0 |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7: AUC10h | 4560 ng*h/mL | Standard Deviation 0 |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1: AUC8h | 4520 ng*h/mL | Standard Deviation 0 |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1: AUCtau | 6770 ng*h/mL | Standard Deviation 0 |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1: AUC8h | 8390 ng*h/mL | Standard Deviation 340 |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1: AUCtau | 12800 ng*h/mL | Standard Deviation 691 |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7: AUC10h | 8250 ng*h/mL | Standard Deviation 1060 |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 1: AUC10h | 4280 ng*h/mL | Standard Deviation 893 |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1: AUCtau | 9800 ng*h/mL | Standard Deviation 0 |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1: AUC10h | 7650 ng*h/mL | Standard Deviation 0 |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter Area Under the Plasma Concentration Curve of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7: AUCtau | 10300 ng*h/mL | Standard Deviation 1740 |
Secondary
Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib
Blood samples for pharmacokinetic (PK) analyses of DS-1205a were obtained at specified time points. Plasma concentrations of DS-1205a were measured using validated assays and non-compartmental analysis.
Time frame: Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 0 (7-day cycle; DS-1205c alone), Days 1 and 7; Predose of Cycle 1 (21-day cycle), Day 1 (DS-1205c + gefitinib); Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 2 (21-day cycle; DS-1205c + gefitinib), Day 1
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 1 | 316 ng/mL | Standard Deviation 46.1 |
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7 | 521 ng/mL | Standard Deviation 17.1 |
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1 | 462 ng/mL | Standard Deviation 48.1 |
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1 | 490 ng/mL | Standard Deviation 19.8 |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 1 | 500 ng/mL | Standard Deviation 141 |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1 | 688 ng/mL | Standard Deviation 130 |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7 | 838 ng/mL | Standard Deviation 130 |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1 | 907 ng/mL | Standard Deviation 266 |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1 | 1030 ng/mL | Standard Deviation 357 |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7 | 1120 ng/mL | Standard Deviation 407 |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1 | 995 ng/mL | Standard Deviation 375 |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 1 | 623 ng/mL | Standard Deviation 251 |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 1 | 521 ng/mL | Standard Deviation 0 |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7 | 580 ng/mL | Standard Deviation 0 |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1 | 632 ng/mL | Standard Deviation 0 |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1 | 677 ng/mL | Standard Deviation 0 |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1 | 1090 ng/mL | Standard Deviation 0 |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1 | 1270 ng/mL | Standard Deviation 99 |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7 | 1080 ng/mL | Standard Deviation 268 |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter of Maximum Concentration (Cmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 1 | 779 ng/mL | Standard Deviation 280 |
Secondary
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib
Blood samples for pharmacokinetic (PK) analyses of DS-1205a were obtained at specified time points. Plasma concentrations of DS-1205a were measured using validated assays and non-compartmental analysis.
Time frame: Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 0 (7-day cycle; DS-1205c alone), Days 1 and 7; Predose of Cycle 1 (21-day cycle), Day 1 (DS-1205c + gefitinib); Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 2 (21-day cycle; DS-1205c + gefitinib), Day 1
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 1 | 3.99 hours |
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1 | 1.93 hours |
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7 | 3.97 hours |
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1 | 3.90 hours |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1 | 4.99 hours |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7 | 4.02 hours |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 1 | 4.99 hours |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1 | 4.00 hours |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7 | 5.08 hours |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 1 | 3.99 hours |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1 | 4.13 hours |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1 | 4.01 hours |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1 | 6.03 hours |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7 | 4.02 hours |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 1 | 4.15 hours |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1 | 4.02 hours |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1 | 0 hours |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 1 | 5.08 hours |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7 | 1.97 hours |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1 | 3.08 hours |
Secondary
Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib
Blood samples for pharmacokinetic (PK) analyses of DS-1205a were obtained at specified time points. Plasma concentrations of DS-1205a were measured using validated assays and non-compartmental analysis.
Time frame: Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 0 (7-day cycle; DS-1205c alone), Days 1 and 7; Predose of Cycle 1 (21-day cycle), Day 1 (DS-1205c + gefitinib); Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 2 (21-day cycle; DS-1205c + gefitinib), Day 1
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set in patients with available samples for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1 | 315 ng/mL | Standard Deviation 21.8 |
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7 | 335 ng/mL | Standard Deviation 16.7 |
| DS-1205c 200 mg + Gefitinib | Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1 | 408 ng/mL | Standard Deviation 136 |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7 | 497 ng/mL | Standard Deviation 44.2 |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1 | 503 ng/mL | Standard Deviation 92.7 |
| DS-1205c 400 mg + Gefitinib | Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1 | 551 ng/mL | Standard Deviation 61.6 |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7 | 691 ng/mL | Standard Deviation 155 |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1 | 768 ng/mL | Standard Deviation 249 |
| DS-1205c 800 mg + Gefitinib | Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1 | 643 ng/mL | Standard Deviation 217 |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1 | 496 ng/mL | Standard Deviation 0 |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7 | 437 ng/mL | Standard Deviation 0 |
| DS-1205c 1000 mg + Gefitinib | Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1 | 486 ng/mL | Standard Deviation 0 |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 1, Day 1 | 1130 ng/mL | Standard Deviation 293 |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 0, Day 7 | 1040 ng/mL | Standard Deviation 330 |
| DS-1205c 1200 mg + Gefitinib | Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of DS-1205a Following Administration of DS-1205c in Combination With Gefitinib | Cycle 2, Day 1 | 1090 ng/mL | Standard Deviation 0 |
Secondary
Progression-free Survival Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib
Progression-free survival (PFS) was defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of radiographic PD or death due to any cause. As per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions.
Time frame: Screening; Cycle 0 (7-day cycle); Cycle 1 and beyond (21-day cycles), Every 6 weeks (± 7 days) in the first 24 weeks after Day 1 of Cycle 1, and every 12 weeks (± 7 days) thereafter; and end-of-treatment, 30 days after last dose, up to 1 year
Population: Progression-free survival (PFS) was assessed in the Full Analysis Set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DS-1205c 200 mg + Gefitinib | Progression-free Survival Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | 6.7 weeks |
| DS-1205c 400 mg + Gefitinib | Progression-free Survival Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | 7.1 weeks |
| DS-1205c 800 mg + Gefitinib | Progression-free Survival Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | 6.9 weeks |
| DS-1205c 1000 mg + Gefitinib | Progression-free Survival Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | 6.7 weeks |
| DS-1205c 1200 mg + Gefitinib | Progression-free Survival Assessed by Investigator Following Administration of DS-1205c in Combination With Gefitinib | 6.9 weeks |