Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
PPAR gamma agonist, Tumor, Cancer, Antineoplastic Agent, Respiratory Tract Neoplasms, Carboplatin, Paclitaxel, Neoplasms
Brief summary
The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with carboplatin and paclitaxel, and to assess the pharmacokinetics of CS-7017 in combination with carboplatin and paclitaxel.
Interventions
DRUGCS-7017
Drug: CS-7017 from 0.25 mg BID to 0.50 mg BID for up to 4\ 6 cycles (1 cycle: 3 weeks)
DRUGCarboplatin
Drug: Carboplatin IV, AUC of 6 mg/mL\*min, once every three weeks for up to 4\ 6 cycles (1 cycle: 3 weeks)
DRUGPaclitaxel
Drug: Paclitaxel IV, 200mg/m\^2, once every three weeks for up to 4\ 6 cycles (1 cycle: 3 weeks)
Sponsors
ICON Clinical Research
Daiichi Sankyo Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed unresectable locally advanced or metastatic (stage IIIb or IV) non-small cell lung cancer (NSCLC) * No prior systemic therapy for NSCLC * Male or female ≥ 18 years of age * Anticipation of more than 3 months survival * Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1 * Adequate organ and bone marrow function
Exclusion criteria
* Anticipation of need for a major surgical procedure or radiation therapy during the study * Remaining influence of previous therapies such as radiotherapy, surgery, immunotherapy within 4 weeks prior to start of study treatment * History of any of the following events within 6 months prior to start of study treatment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class ≥I congestive heart failure (CHF), cerebrovascular accident or cerebral infarction, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe chronic-obstructive pulmonary disease (COPD) or asthma) * Severe edema, ascites fluid, pericardial or pleural effusion or pericardial involvement with the tumor within 6 months prior to start of study treatment, or which require steroid therapy/ diuretic therapy * Subjects with brain metastasis (defined as untreated, symptomatic or requiring steroids or anticonvulsant medications to control associated symptoms) * Subjects with clinically significant active infection which requires antibiotic therapy, or who are hepatitis B surface antigen (HBs)- or hepatitis C virus (HCV)- or human immunodeficiency virus (HIV)- positive and receiving antiretroviral therapy * Subjects with malabsorption syndrome, chronic diarrhea (lasting over 4 weeks), inflammatory bowel disease, or partial bowel obstruction * Diabetes mellitus requiring insulin, or a history of poor serum glucose control with the use of non-insulin diabetes medications * Treatment with thiazolidinediones (TZDs) within 4 weeks prior to start of study treatment * History of a second malignancy, with the exception of in situ cervical cancer or adequately treated basal cell or squamous cell carcinoma of the skin * Poorly-controlled blood pressure as judged by the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose | The area under the concentration versus time curve during dosing interval (AUCtau) and up to the last quantifiable time (AUClast) of geometric means of CS-7017 are reported at selected cycles (C) and days (D). |
| Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose | The maximum serum concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D). |
| Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose | The time of maximum plasma concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D). |
| Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Baseline to end of Cycle 1, with each treatment cycle being 3 weeks | Treatment-emergent adverse events (TEAEs) are defined as those adverse events that occur, having been absent before the study, or worsen in severity after the initiation of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Baseline up to Week 18 postdose | The best overall response is the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], stable disease \[SD\], and progressive disease \[PD\]) among all overall responses from the start of treatment until the participant withdraws from the study. Participants who did not have a tumor assessment, the best overall response is Not Evaluable (NE). The response rate was defined as the proportion of participants with a best overall response of CR or PR, ie, \[confirmed and unconfirmed, (CR + PR) / number of participants\]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, CR was defined as the disappearance of all target lesions, PR was defined as ≥30% decrease in the sum of diameters of target lesions, PD was defined as ≥20 increase in the smallest sum of diameters, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Baseline to 30 days after last dose, up to approximately 1 year | Treatment-emergent adverse events (TEAEs) are defined as those adverse events that occur, having been absent before the study, or worsen in severity after the initiation of study drug. CS-7017-related TEAEs are those TEAEs that are related to CS-7017 in the relationship. |
Countries
South Korea
Participant flow
Recruitment details
A total of 18 participants were screened for eligibility. Of the 18 participants who were screened, 16 participants who met all inclusion criteria and no exclusion criteria were enrolled from 17 March 2010 to 15 April 2011 at 1 site in South Korea. All 16 participants received treatment.
Pre-assignment details
This dose-escalating study included an initial and additional portion. Participants received CS-7017 combination treatment with carboplatin & paclitaxel (starting dose 0.25 mg twice daily \[BID\] in the initial portion). In the additional portion, the CS-7017 dose was determined (0.50 mg BID) based on the initial portion.
Participants by arm
| Arm | Count |
|---|---|
| CS-7017 0.25 mg BID; Initial Portion Participants who received 0.25 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min. | 3 |
| CS-7017 0.50 mg BID; Initial Portion Participants who received 0.50 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min. | 4 |
| CS-7017 0.50 mg BID; Additional Portion Participants who received 0.5 mg twice daily (BID) CS-7017 combination treatment administered orally. Paclitaxel was administered intravenously at a dose of 200 mg/m\^2 over 3 hours immediately after administration of CS-7017. Carboplatin was administered intravenously. The dose of the carboplatin was calculate using Calvert formula and target area under the plasma concentration-time curve (AUC) of 6 mg/mL\*min.
Cycle 1, Day 1: Carboplatin and paclitaxel only
Cycle 1, Day 3: CS-7017 at the dose selected in initial portion
Subsequent cycles: CS-7017 with carboplatin and paclitaxel | 9 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 1 |
| Overall Study | Progressive disease | 2 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | CS-7017 0.25 mg BID; Initial Portion | CS-7017 0.50 mg BID; Initial Portion | CS-7017 0.50 mg BID; Additional Portion |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 2 Participants | 2 Participants | 6 Participants |
| Age, Continuous | 59.9 years STANDARD_DEVIATION 8.59 | 59.7 years STANDARD_DEVIATION 9.29 | 62.3 years STANDARD_DEVIATION 5.91 | 58.9 years STANDARD_DEVIATION 9.98 |
| Region of Enrollment South Korea | 16 participants | 3 participants | 4 participants | 9 participants |
| Sex: Female, Male Female | 5 Participants | 1 Participants | 0 Participants | 4 Participants |
| Sex: Female, Male Male | 11 Participants | 2 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 1 / 4 | 0 / 9 |
| other Total, other adverse events | 3 / 3 | 4 / 4 | 9 / 9 |
| serious Total, serious adverse events | 2 / 3 | 1 / 4 | 6 / 9 |
Outcome results
Primary
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer
The area under the concentration versus time curve during dosing interval (AUCtau) and up to the last quantifiable time (AUClast) of geometric means of CS-7017 are reported at selected cycles (C) and days (D).
Time frame: Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CS-7017 0.25 mg BID; Initial Portion | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 1, Week 1: AUCtau | 70.66 ng*h/mL | Standard Deviation 54.11 |
| CS-7017 0.25 mg BID; Initial Portion | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 1, Week 1: AUClast | 49.57 ng*h/mL | Standard Deviation 36.86 |
| CS-7017 0.25 mg BID; Initial Portion | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 2, Week 4: AUCtau | 132.47 ng*h/mL | Standard Deviation 25.49 |
| CS-7017 0.25 mg BID; Initial Portion | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 2, Week 4: AUClast | 95.94 ng*h/mL | Standard Deviation 15.84 |
| CS-7017 0.50 mg BID; Initial Portion | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 2, Week 4: AUClast | 240.61 ng*h/mL | Standard Deviation 107.09 |
| CS-7017 0.50 mg BID; Initial Portion | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 1, Week 1: AUCtau | 209.33 ng*h/mL | Standard Deviation 131.4 |
| CS-7017 0.50 mg BID; Initial Portion | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 2, Week 4: AUCtau | 345.56 ng*h/mL | Standard Deviation 156.29 |
| CS-7017 0.50 mg BID; Initial Portion | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 1, Week 1: AUClast | 87.23 ng*h/mL | Standard Deviation 85.69 |
| CS-7017 0.50 mg BID; Additional Portion | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 2, Week 4: AUClast | 268.00 ng*h/mL | Standard Deviation 134.4 |
| CS-7017 0.50 mg BID; Additional Portion | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 1, Week 1: AUClast | 81.54 ng*h/mL | Standard Deviation 66.01 |
| CS-7017 0.50 mg BID; Additional Portion | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 2, Week 4: AUCtau | 400.89 ng*h/mL | Standard Deviation 212.22 |
| CS-7017 0.50 mg BID; Additional Portion | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 1, Week 1: AUCtau | 203.99 ng*h/mL | Standard Deviation 91.34 |
Primary
Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer
The maximum serum concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D).
Time frame: Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CS-7017 0.25 mg BID; Initial Portion | Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 1, Week 1: Cmax | 8.90 ng/mL | Standard Deviation 7.01 |
| CS-7017 0.25 mg BID; Initial Portion | Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 2, Week 4: Cmax,ss | 13.63 ng/mL | Standard Deviation 1.77 |
| CS-7017 0.50 mg BID; Initial Portion | Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 1, Week 1: Cmax | 15.98 ng/mL | Standard Deviation 16.77 |
| CS-7017 0.50 mg BID; Initial Portion | Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 2, Week 4: Cmax,ss | 33.83 ng/mL | Standard Deviation 15.42 |
| CS-7017 0.50 mg BID; Additional Portion | Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 1, Week 1: Cmax | 14.54 ng/mL | Standard Deviation 9.75 |
| CS-7017 0.50 mg BID; Additional Portion | Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 2, Week 4: Cmax,ss | 39.58 ng/mL | Standard Deviation 18.63 |
Primary
Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer
The time of maximum plasma concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D).
Time frame: Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CS-7017 0.25 mg BID; Initial Portion | Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 1, Week 1: Tmax | 3.90 h |
| CS-7017 0.25 mg BID; Initial Portion | Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 2, Week 4: Tmax,ss | 3.17 h |
| CS-7017 0.50 mg BID; Initial Portion | Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 1, Week 1: Tmax | 3.00 h |
| CS-7017 0.50 mg BID; Initial Portion | Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 2, Week 4: Tmax,ss | 3.98 h |
| CS-7017 0.50 mg BID; Additional Portion | Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 1, Week 1: Tmax | 5.95 h |
| CS-7017 0.50 mg BID; Additional Portion | Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Cycle 2, Week 4: Tmax,ss | 3.88 h |
Primary
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer
Treatment-emergent adverse events (TEAEs) are defined as those adverse events that occur, having been absent before the study, or worsen in severity after the initiation of study drug.
Time frame: Baseline to end of Cycle 1, with each treatment cycle being 3 weeks
Population: TEAEs were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Fatigue | 3 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Musculoskeletal and Connective Tissue Disorders | 3 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Respiratory, Thoracic and Mediastinal Disorders | 1 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Anaemia | 0 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Pruritus | 0 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Pleural effusion | 0 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Weight increased | 0 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Alopecia | 2 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Gastrointestinal Disorders | 2 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | General Disorders & Administration Site Conditions | 3 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Skin and Subcutaneous Tissue Disorders | 2 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Nausea | 2 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Metabolism and Nutrition Disorders | 0 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Investigations | 0 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Athralgia | 1 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Decreased appetite | 0 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Neutropenia | 3 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | At least one TEAE | 3 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Nervous System Disorders | 1 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Blood and lymphatic system disorders | 3 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Myalgia | 2 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Neuropathy peripheral | 0 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Myalgia | 0 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | At least one TEAE | 4 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Blood and lymphatic system disorders | 2 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Neutropenia | 2 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Anaemia | 0 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Metabolism and Nutrition Disorders | 2 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Decreased appetite | 1 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Nervous System Disorders | 1 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Neuropathy peripheral | 1 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Respiratory, Thoracic and Mediastinal Disorders | 0 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Pleural effusion | 0 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Gastrointestinal Disorders | 1 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Nausea | 1 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Skin and Subcutaneous Tissue Disorders | 2 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Alopecia | 1 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Pruritus | 2 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Musculoskeletal and Connective Tissue Disorders | 2 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Athralgia | 2 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | General Disorders & Administration Site Conditions | 1 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Fatigue | 0 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Investigations | 2 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Weight increased | 2 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Pruritus | 1 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Neuropathy peripheral | 4 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Blood and lymphatic system disorders | 8 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Musculoskeletal and Connective Tissue Disorders | 7 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Nervous System Disorders | 4 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Decreased appetite | 6 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Myalgia | 6 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Metabolism and Nutrition Disorders | 6 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Weight increased | 7 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Athralgia | 0 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Anaemia | 5 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Investigations | 8 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | General Disorders & Administration Site Conditions | 5 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Nausea | 1 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Gastrointestinal Disorders | 6 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Neutropenia | 7 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Skin and Subcutaneous Tissue Disorders | 8 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Pleural effusion | 4 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | At least one TEAE | 9 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Alopecia | 8 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Respiratory, Thoracic and Mediastinal Disorders | 4 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Fatigue | 1 Participants |
Secondary
Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC)
The best overall response is the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], stable disease \[SD\], and progressive disease \[PD\]) among all overall responses from the start of treatment until the participant withdraws from the study. Participants who did not have a tumor assessment, the best overall response is Not Evaluable (NE). The response rate was defined as the proportion of participants with a best overall response of CR or PR, ie, \[confirmed and unconfirmed, (CR + PR) / number of participants\]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, CR was defined as the disappearance of all target lesions, PR was defined as ≥30% decrease in the sum of diameters of target lesions, PD was defined as ≥20 increase in the smallest sum of diameters, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time frame: Baseline up to Week 18 postdose
Population: Best overall response and objective response rate were assessed in the Efficacy Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CS-7017 0.25 mg BID; Initial Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Complete response (CR) | 0 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Response rate (CR + PR) | 0 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Missing | 0 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Stable disease (SD) | 1 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Partial response (PR) | 0 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Progressive disease (PD) | 2 Participants |
| CS-7017 0.25 mg BID; Initial Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Not evaluable (NE) | 0 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Not evaluable (NE) | 0 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Progressive disease (PD) | 1 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Partial response (PR) | 2 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Complete response (CR) | 0 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Missing | 0 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Stable disease (SD) | 0 Participants |
| CS-7017 0.50 mg BID; Initial Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Response rate (CR + PR) | 2 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Progressive disease (PD) | 2 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Complete response (CR) | 0 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Partial response (PR) | 4 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Stable disease (SD) | 2 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Not evaluable (NE) | 0 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Missing | 0 Participants |
| CS-7017 0.50 mg BID; Additional Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Response rate (CR + PR) | 4 Participants |
| CS71017 0.5 mg BID; Initial and Additional Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Stable disease (SD) | 2 Participants |
| CS71017 0.5 mg BID; Initial and Additional Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Not evaluable (NE) | 0 Participants |
| CS71017 0.5 mg BID; Initial and Additional Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Partial response (PR) | 6 Participants |
| CS71017 0.5 mg BID; Initial and Additional Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Response rate (CR + PR) | 6 Participants |
| CS71017 0.5 mg BID; Initial and Additional Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Missing | 0 Participants |
| CS71017 0.5 mg BID; Initial and Additional Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Complete response (CR) | 0 Participants |
| CS71017 0.5 mg BID; Initial and Additional Portion | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Progressive disease (PD) | 3 Participants |
| Overall | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Stable disease (SD) | 3 Participants |
| Overall | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Response rate (CR + PR) | 6 Participants |
| Overall | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Missing | 0 Participants |
| Overall | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Not evaluable (NE) | 0 Participants |
| Overall | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Partial response (PR) | 6 Participants |
| Overall | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Complete response (CR) | 0 Participants |
| Overall | Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) | Progressive disease (PD) | 5 Participants |
Secondary
CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer
Treatment-emergent adverse events (TEAEs) are defined as those adverse events that occur, having been absent before the study, or worsen in severity after the initiation of study drug. CS-7017-related TEAEs are those TEAEs that are related to CS-7017 in the relationship.
Time frame: Baseline to 30 days after last dose, up to approximately 1 year
Population: CS-7017-related TEAEs were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CS-7017 0.25 mg BID; Initial Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Pleural effusion | 0 Participants |
| CS-7017 0.25 mg BID; Initial Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | At least one CS-7017-related TEAE | 2 Participants |
| CS-7017 0.25 mg BID; Initial Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Respiratory, Thoracic and Mediastinal Disorders | 0 Participants |
| CS-7017 0.25 mg BID; Initial Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | General Disorders & Administration Site Conditions | 1 Participants |
| CS-7017 0.25 mg BID; Initial Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Face oedema | 1 Participants |
| CS-7017 0.25 mg BID; Initial Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Oedema peripheral | 0 Participants |
| CS-7017 0.25 mg BID; Initial Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Investigations | 1 Participants |
| CS-7017 0.25 mg BID; Initial Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Weight increased | 1 Participants |
| CS-7017 0.50 mg BID; Initial Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Pleural effusion | 1 Participants |
| CS-7017 0.50 mg BID; Initial Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Investigations | 3 Participants |
| CS-7017 0.50 mg BID; Initial Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | General Disorders & Administration Site Conditions | 2 Participants |
| CS-7017 0.50 mg BID; Initial Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Face oedema | 2 Participants |
| CS-7017 0.50 mg BID; Initial Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Oedema peripheral | 2 Participants |
| CS-7017 0.50 mg BID; Initial Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | At least one CS-7017-related TEAE | 3 Participants |
| CS-7017 0.50 mg BID; Initial Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Weight increased | 3 Participants |
| CS-7017 0.50 mg BID; Initial Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Respiratory, Thoracic and Mediastinal Disorders | 1 Participants |
| CS-7017 0.50 mg BID; Additional Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Respiratory, Thoracic and Mediastinal Disorders | 4 Participants |
| CS-7017 0.50 mg BID; Additional Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Oedema peripheral | 3 Participants |
| CS-7017 0.50 mg BID; Additional Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Pleural effusion | 4 Participants |
| CS-7017 0.50 mg BID; Additional Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | General Disorders & Administration Site Conditions | 7 Participants |
| CS-7017 0.50 mg BID; Additional Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Investigations | 8 Participants |
| CS-7017 0.50 mg BID; Additional Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | At least one CS-7017-related TEAE | 8 Participants |
| CS-7017 0.50 mg BID; Additional Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Face oedema | 4 Participants |
| CS-7017 0.50 mg BID; Additional Portion | CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer | Weight increased | 8 Participants |