Phase 3
Completed N=569
Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer
Source: ClinicalTrials.gov NCT02481830 ↗Enrolled (actual)
569
Serious AEs
64.7%
Results posted
Jan 2020
Primary outcomePrimary: Overall Survival (OS) — 7.46; 8.38 Months — p=0.1144
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
7.46; 8.38 | 0.1144 |
| SECONDARY Progression Free Survival (PFS) |
1.45; 3.71 | — |
| SECONDARY Objective Response Rate (ORR) |
13.7; 16.8 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed small cell lung cancer (SCLC)
- Subjects with either limited or extensive disease stage at the initial diagnosis
- Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of limited or extensive disease stage SCLC
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria
- Untreated or symptomatic central nervous system (CNS) metastases
- Prior therapy with anti-PD-1, anti-PDL1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody
- Inadequate hematologic or hepatic function
Data sourced from ClinicalTrials.gov (NCT02481830). 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. Informational only — not medical advice.