An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy

Phase 3

Completed

Conditions: Lung Cancer

Registration Number: NCT02538666

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 907

Inclusion Criteria

Subjects with histologically or cytologically confirmed extensive stage disease SCLC
Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

Subjects with symptomatic Central Nervous System (CNS) metastases
Subjects receiving consolidative chest radiation
Subjects with active, known, or suspected autoimmune disease are excluded
All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline

Other protocol-defined inclusion/exclusion criteria apply

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population	From randomization to 400 deaths across the two treatment groups (Nivo+Ipi vs Placebo) (up to approximately 37 months)	OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS) of Nivolumab Versus Placebo	From randomization to the date of death or last known alive date (up to approximately 73 months)	Overall Survival (OS) comparing nivolumab monotherapy versus placebo. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Nivolumab	From randomization to the date of death or last known alive date (up to approximately 73 months)	Overall Survival (OS) comparing Nivolumab + Ipilimumab Versus Nivolumab. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.
Progression Free Survival (PFS) Per BICR	From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)	PFS was defined as the time between the date of randomization and the first date of documented progression as determined by Blind Independent Central Review (BICR) or death due to any cause, whichever occurred first. Participants who died with no reported progression were considered to have progressed on the date of death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on study tumor assessments and did not die (or died after initiation of the subsequent anti- cancer therapy) were censored on their date of randomization. Participants who started any subsequent anti- cancer therapy without a prior reported Progressive Disease (PD) per BICR were censored at the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.
Overall Survival (OS) in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population	From randomization to the date of death or last known alive date (up to approximately 73 months)	Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined. OS in TMB by the following cutoff points: ≥10 mutations/mb, \< 10 mutations/mb, ≥13 mutations/mb, \<13 mutations/mb
Progression Free Survival (PFS) Per BICR in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population	From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)	Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined. PFS in TMB by the following cutoff points: ≥10 mutations/mb, \< 10 mutations/mb, ≥13 mutations/mb, \<13 mutations/mb.

Trial Locations

Locations (176): Local Institution - 0003
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Sacramento, California, United States
Local Institution - 0202
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New Haven, Connecticut, United States
Local Institution - 0127
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Fort Myers, Florida, United States
Local Institution - 0007
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Jacksonville, Florida, United States
Local Institution - 0128
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Saint Petersburg, Florida, United States
Local Institution - 0010
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Atlanta, Georgia, United States
Local Institution - 0013
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Indianapolis, Indiana, United States
Local Institution - 0061
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Fairway, Kansas, United States
Local Institution - 0012
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Wichita, Kansas, United States
Local Institution - 0032
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Lexington, Kentucky, United States
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Local Institution - 0003
🇺🇸Sacramento, California, United States