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Sorafenib in Treating Patients With Extensive Stage Small Cell Lung Cancer

A Phase II Trial of BAY 43-9006 (NSC-724772) in Patients With Platinum-Treated Extensive Stage Small Cell Lung Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00182689
Enrollment
89
Registered
2005-09-16
Start date
2005-07-31
Completion date
2008-10-31
Last updated
2014-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer

Brief summary

This phase II trial is studying how well sorafenib works in treating patients with extensive stage small cell lung cancer. Sorafenib may stop the growth of small cell lung cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of BAY 43-0006 in previously-treated, platinum-sensitive and platinum-refractory patients with measurable disease and extensive stage small cell lung cancer (E-SCLC) in terms of response rate (confirmed and unconfirmed, complete and partial). SECONDARY OBJECTIVES: I. To assess the qualitative and quantitative toxicities of BAY 43-9006 in this patient population. II. To assess overall survival in this group of patients treated with BAY 43-9006. III. To collect specimens via the Lung Cancer Specimen Repository Protocol (S9925) in order to perform exploratory analyses of the relationship between selected markers and patient outcomes. OUTLINE: This is a multicenter study. Patients are stratified according to platinum sensitivity status (platinum sensitive vs platinum refractory). Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for up to 2 years from study entry.

Interventions

DRUGsorafenib tosylate

Given orally

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

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

* Patients must have histologically or cytologically-confirmed diagnosis of small cell lung cancer and must have extensive disease with progression or recurrence after receiving a standard first-time regimen containing either cisplatin or carboplatin; patients who receive primary curative chemoradiation therapy for limited disease, but who recur within the primary tumor site, previously radiated field or with distant metastases are also allowed to participate; diagnosis based on sputum cytology is acceptable if confirmation by an independent pathologic review at the institution is documented; patients who have clinical evidence of recurrent small cell lung cancer do not require a confirmatory biopsy to be eligible for this trial * Patients must have measurable disease per RECIST criteria; patients must have evidence of disease by plain radiographs, CT scan or MRI scan; all x-rays/scans to assess measurable disease must have been performed within 28 days prior to registration; all other required test to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed * Patients must have been previously treated with exactly one regimen; this must have included cisplatin or carboplatin; in addition, information must be available to place the patient in one of the two following categories: * Platinum sensitive disease: defined as an initial response to platinum-based chemotherapy who subsequently progressed \> 90 days after last platinum treatment; best response to platinum-based treatment: CR, PR, stable or progression while on treatment (circle one); NOTE: Prior chemotherapy must have been completed at least 90 days prior to registration OR * Platinum refractory disease; no response to platinum-based chemotherapy, progression during platinum-based therapy, or progression within 90 days of completing platinum-based therapy * Patient may have receive previous radiation therapy, but it must have been completed at least 21 days prior to registration and the patient should have recovered from all associated toxicities; there must be no plans for the patients to receive concurrent radiation therapy to measurable lesions; measurable disease may be present inside the area of prior radiation therapy provided that the lesion is demonstrated to be progressing by CT scan or there is measurable disease outside the prior radiation field * Patients may have received prior surgery provided that at least 14 days have elapsed since surgery (thoracic or other major surgeries) and the patient has recovered from all associated toxicities; patients must have disease outside the area of previous surgical resection or a new lesion must be present * CORRELATIVE SCIENCE STUDIES: Institutions must have IRB approval of S9925 (the Lung Cancer Specimen Repository); patients must be offered participation in S9925; with the patient's consent, specimens will be submitted for testing via S9925; patients must be registered separately to S9925 in order for institutions to receive credit for specimen submission * Serum creatinine =\< the institutional upper limit of normal OR creatinine clearance \>= 60 cc/min * Bilirubin =\< 2 x the institutional upper limit of normal * Alkaline phosphatase =\< 2 x the institutional upper limit of normal * SGOT or SGPT =\< 2 x the institutional upper limit of normal * PTT and either PT or INR \< 1.5 x the institutional upper limit of normal (except in patients who are on warfarin \[Coumadin or heparin\] obtained within 28 days prior to registration); patients who receive anti-coagulation treatment with an agent such as warfarin or heparin, prophylactically or therapeutically, will be allowed to participate * Patients must not have any evidence of bleeding diathesis * ANC \>= 1,500/uL * Platelet count \>= 100,000/uL * Patients must have a Zubrod performance status 0-1 * Patients with known brain and/or leptomeningeal metastases are eligible only if he/she is asymptomatic, without deficits on neurologic exam and is not receiving corticosteroid therapy to control symptoms; only a non-enzyme inducing anticonvulsant (e.g., Keppra) will be permitted for those patients requiring anticonvulsants; all patients must have a pretreatment CT or MRI scan of the brain to evaluate CNS disease within 28 days prior to registration * Any ongoing requirement for systemic corticosteroid therapy is not permitted; topical and/or inhaled steroids are allowed * Patients must either be able to swallow and/or receive enteral medications via gastrostomy feeding tube; patients with intractable nausea or vomiting are not eligible; patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis) are not eligible * The effects of BAY 43-9006 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Patients must not have a significant history of cardiac disease, e.g., uncontrolled hypertension, unstable angina, congestive-heart failure, and myocardial infarction within the last six months, or cardiac ventricular arrhythmias requiring medication * Patients must be willing to provide prior smoking history * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years * All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

Design outcomes

Primary

MeasureTime frameDescription
Objective Response (Confirmed and Unconfirmed, Complete and Partial Responses Per RECIST)8 weeks to 2 yearsComplete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.

Secondary

MeasureTime frameDescription
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPatients were assessed for adverse events after completion of every 28-day cycle.Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Overall Survival0 - 2 yearsMeasured from time of registration to death, or last contact date

Countries

United States

Participant flow

Participants by arm

ArmCount
Platinum-Sensitive
Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression \>90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
38
Platinum-Refractory
Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or \<=90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
45
Total83

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event811
Overall StudyDeath10
Overall StudyIneligible14
Overall StudyNever received treatment10
Overall Studynot protocol specified03
Overall StudyProgression2729
Overall StudyWithdrawal by Subject22

Baseline characteristics

CharacteristicTotalPlatinum-SensitivePlatinum-Refractory
Age, Continuous62 years65 years60 years
Performance Status
0
30 participants15 participants15 participants
Performance Status
1
51 participants22 participants29 participants
Performance Status
Not reported
2 participants1 participants1 participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants1 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
76 Participants35 Participants41 Participants
Sex: Female, Male
Female
36 Participants18 Participants18 Participants
Sex: Female, Male
Male
47 Participants20 Participants27 Participants
Sites of Metastases
Multiple organs
66 participants32 participants34 participants
Sites of Metastases
None
4 participants1 participants3 participants
Sites of Metastases
Not reported
2 participants1 participants1 participants
Sites of Metastases
Single organ
11 participants4 participants7 participants
Smoking History
Current
42 participants17 participants25 participants
Smoking History
Former
40 participants21 participants19 participants
Smoking History
Never
0 participants0 participants0 participants
Smoking History
Not reported
1 participants0 participants1 participants
Weight Loss Prior 6 Months
10% to < 20%
6 participants1 participants5 participants
Weight Loss Prior 6 Months
< 5%
57 participants26 participants31 participants
Weight Loss Prior 6 Months
5% to < 10%
11 participants5 participants6 participants
Weight Loss Prior 6 Months
Not reported
7 participants5 participants2 participants
Weight Loss Prior 6 Months
> or = 20%
2 participants1 participants1 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
37 / 3838 / 44
serious
Total, serious adverse events
6 / 387 / 44

Outcome results

Primary

Objective Response (Confirmed and Unconfirmed, Complete and Partial Responses Per RECIST)

Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.

Time frame: 8 weeks to 2 years

Population: All eligible patients who received treatment were included in this measure.

ArmMeasureValue (NUMBER)
Platinum SensitiveObjective Response (Confirmed and Unconfirmed, Complete and Partial Responses Per RECIST)11 percentage of participants
Platinum RefractoryObjective Response (Confirmed and Unconfirmed, Complete and Partial Responses Per RECIST)2 percentage of participants
Secondary

Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug

Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Time frame: Patients were assessed for adverse events after completion of every 28-day cycle.

Population: Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.

ArmMeasureGroupValue (NUMBER)
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLipase0 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAnorexia2 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugMuscle weakness, not d/t neuropathy - body/general0 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHypertension3 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAtaxia (incoordination)0 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugNeuropathy: sensory1 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDyspnea (shortness of breath)3 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPTT (Partial thromboplastin time)0 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugBilirubin (hyperbilirubinemia)0 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Abdomen NOS1 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugNausea1 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Extremity-limb0 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPotassium, serum-low (hypokalemia)1 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Joint1 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDiarrhea0 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain-Other (Specify)1 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugVomiting0 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPancreatitis0 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDizziness1 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPhosphate, serum-low (hypophosphatemia)1 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugConfusion1 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPleural effusion (non-malignant)0 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugFatigue (asthenia, lethargy, malaise)5 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPneumonitis/pulmonary infiltrates1 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugWeight loss0 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugFever in absence of neutropenia, ANC lt1.0x10e9/L0 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugRash/desquamation1 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemoglobin0 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugRash: acne/acneiform2 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugINR (of prothrombin time)1 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugRash: erythema multiforme0 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAST, SGOT1 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugRash: hand-foot skin reaction9 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - Skin1 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSodium, serum-low (hyponatremia)1 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAllergic reaction/hypersensitivity0 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSpeech impairment (e.g., dysphasia or aphasia)0 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - UTI0 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSyncope (fainting)1 Participants with a given type of AE
Platinum SensitiveNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDehydration0 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSyncope (fainting)0 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugConfusion2 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDyspnea (shortness of breath)0 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemoglobin1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHypertension0 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugVomiting1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugWeight loss1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAllergic reaction/hypersensitivity1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAnorexia1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAtaxia (incoordination)1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugBilirubin (hyperbilirubinemia)1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDehydration2 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDiarrhea2 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDizziness0 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugFatigue (asthenia, lethargy, malaise)3 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugFever in absence of neutropenia, ANC lt1.0x10e9/L1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugINR (of prothrombin time)0 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - Skin0 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - UTI1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLipase1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugMuscle weakness, not d/t neuropathy - body/general1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugNausea1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugNeuropathy: sensory0 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPTT (Partial thromboplastin time)1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Abdomen NOS2 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Extremity-limb1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Joint1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain-Other (Specify)1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPancreatitis1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPhosphate, serum-low (hypophosphatemia)1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPleural effusion (non-malignant)1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPneumonitis/pulmonary infiltrates0 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPotassium, serum-low (hypokalemia)0 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugRash/desquamation2 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugRash: acne/acneiform0 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugRash: erythema multiforme1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugRash: hand-foot skin reaction8 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSodium, serum-low (hyponatremia)2 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSpeech impairment (e.g., dysphasia or aphasia)1 Participants with a given type of AE
Platinum RefractoryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAST, SGOT0 Participants with a given type of AE
Secondary

Overall Survival

Measured from time of registration to death, or last contact date

Time frame: 0 - 2 years

ArmMeasureValue (MEDIAN)
Platinum SensitiveOverall Survival6.7 months
Platinum RefractoryOverall Survival5.3 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026