Trials / Completed
CompletedNCT02367794
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]
A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,021 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody | Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle. |
| DRUG | Carboplatin | Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles. |
| DRUG | Nab-Paclitaxel | Nab-paclitaxel 100 milligrams per meter squared (mg/m\^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles. |
| DRUG | Paclitaxel | Paclitaxel 200 mg/m\^2 IV on Day 1 of each 21-day cycle for 4 or 6 cycles. Participants of Asian race/ethnicity will be administered paclitaxel 175 mg/m\^2 IV. |
Timeline
- Start date
- 2015-06-11
- Primary completion
- 2018-10-03
- Completion
- 2021-02-17
- First posted
- 2015-02-20
- Last updated
- 2022-03-21
- Results posted
- 2019-11-12
Locations
242 sites across 26 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, France, Germany, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Peru, Portugal, Russia, Singapore, Slovakia, Spain, Taiwan, Ukraine
Source: ClinicalTrials.gov record NCT02367794. Inclusion in this directory is not an endorsement.