drugset / Trial / NCT02574078
A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.
Timeline
- Start
- 2015-11-23
- Primary completion
- 2020-04-15
- Completion
- 2020-04-15
Outcome
Mixed primary results
registry analysis (superiority test); Group C, Nivo vs Group C, ICC; p = 0.0442; Hazard Ratio (HR) 2.04 (95% CI 1.00 to 4.16); Unstratified log-rank NCT02574078 ↗
registry analysis (superiority test); Group B, Nivo vs Group B, BSC; p = 0.0241; Hazard Ratio (HR) 0.31 (95% CI 0.11 to 0.91); Unstratified log-rank NCT02574078 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | — | — |
| Comparator | Carboplatin | Small molecule | — | — |
| Subject | Crizotinib | Small molecule | — | — |
| Comparator | Docetaxel | Small molecule | — | — |
| Subject | Erlotinib | Small molecule | — | — |
| Comparator | Gemcitabine | Small molecule | — | — |
| Comparator | Nab-paclitaxel | Small molecule | — | — |
| Subject | Nivolumab | Monoclonal antibody | — | — |
| Comparator | Paclitaxel | Small molecule | — | — |
| Subject | Pemetrexed | Small molecule | — | — |