Phase 3
N=907
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
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02538666 ↗Enrolled (actual)
907
Serious AEs
53.4%
Results posted
Oct 2019
Primary outcome: Primary: Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population — 9.56; 9.17 Months — p=0.3693
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nivolumab (Biological); Ipilimumab (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population |
9.56; 9.17 | 0.3693 |
| SECONDARY Overall Survival (OS) of Nivolumab Versus Placebo |
9.56; 10.18; 9.28; 8.18 | — |
| SECONDARY Overall Survival (OS) of Nivolumab + Ipilimumab Versus Nivolumab |
10.18; 9.17; 8.18; 10.48 | — |
| SECONDARY Progression Free Survival (PFS) Per BICR |
1.41; 1.94; 1.74; 1.38; 1.58; 1.54 | — |
| SECONDARY Overall Survival (OS) in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population |
11.96; 12.81; 10.55; 9.20; 9.76; 8.11 | — |
| SECONDARY Progression Free Survival (PFS) Per BICR in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population |
1.58; 2.79; 2.33; 1.41; 1.61; 1.48 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02538666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.