A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]
Summary
This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.
Timeline
- Start
- 2015-06-11
- Primary completion
- 2018-10-03
- Completion
- 2021-02-17
Outcome
Mixed primary results
registry Arm C: Nab-Paclitaxel + Carboplatin vs Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin; p = 0.0006; Hazard Ratio (HR) 0.75 (95% CI 0.64 to 0.88) NCT02367794 ↗
registry MEDIAN Arm C: Nab-Paclitaxel + Carboplatin: 5.6 (5.5 to 5.7) Months NCT02367794 ↗
registry MEDIAN Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin: 6.5 (5.7 to 7.1) Months NCT02367794 ↗
registry Arm C: Nab-Paclitaxel + Carboplatin vs Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin; p = 0.1581; Hazard Ratio (HR) 0.88 (95% CI 0.73 to 1.05) NCT02367794 ↗
registry MEDIAN Arm C: Nab-Paclitaxel + Carboplatin: 13.5 (12.2 to 15.1) Months NCT02367794 ↗
registry MEDIAN Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin: 14.2 (12.3 to 16.8) Months NCT02367794 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Carboplatin | Small molecule | 6 unknown | — |
| Subject | Nab-paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |