Clinical trial · Interventional
Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer
An Open-label, Randomized, Phase 3 Study of Nivolumab or Chemotherapy in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First Line Chemotherapy (CheckMate 331: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 331)
NCT02481830CI-TRIAL-00068316CheckMate331completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A Nivolumab
- description
- Nivolumab intravenous infusion as specified
- interventionNames
- Drug: Nivolumab
- type
- ACTIVE_COMPARATOR
- label
- Arm B Chemotherapy Topotecan
- description
- Topotecan as specified
- interventionNames
- Drug: Topotecan
- type
- ACTIVE_COMPARATOR
- label
- Arm B Chemotherapy Amrubicin
- description
- Amrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.