drugset / Trial / NCT02481830
Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.
Timeline
- Start
- 2015-09-14
- Primary completion
- 2018-08-17
- Completion
- 2022-08-30
Outcome
Missed primary endpoint
registry analysis (superiority test); Group A vs Group B; p = 0.1144; Hazard Ratio (HR) 0.86 (95% CI 0.72 to 1.04); Log Rank NCT02481830 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amrubicin | Small molecule | — | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | — | Intravenous |
| Comparator | Topotecan | Small molecule | — | — |