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]
Completed · Phase 3
Conditions studied: Squamous Non-Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT02367794
- Run by
- Hoffmann-La Roche
- People needed
- 1021
- Starts
- 2015-06-11
- Expected to finish
- 2021-02-17
- Last updated by the study team
- 2022-03-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC
- Previously obtained archival tumor tissue or tissue obtained from biopsy at screening
- Measurable disease as defined by RECIST v1.1
- Adequate hematologic and end organ function
You may not qualify if…
- Active or untreated central nervous system (CNS) metastasis
- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- Pregnant or lactating women
- History of autoimmune disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan, History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Positive test for Human Immunodeficiency Virus (HIV)
- Active hepatitis B or hepatitis C
- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
- Severe infection within 4 weeks prior to randomization
- Significant history of cardiovascular disease
Where it is running
- Highlands Oncology Group — Springdale, Arkansas, United States
- Southern CA Permanente Med Grp — Bellflower, California, United States
- Kaiser Permanente Oakland Medical Center — Oakland, California, United States
- Kaiser Permanente - Sacramento Medical Center and Medical Offices — Sacramento, California, United States
- Kaiser Permanente - San Leandro Medical Center — San Leandro, California, United States
- Kaiser Permanente - Santa Clara — Santa Clara, California, United States
- Kaiser Permanente; Oncology Clinical Trials — Vallejo, California, United States
- Kaiser Permanente - Walnut Creek — Walnut Creek, California, United States
- Rocky Mountain Cancer Center — Denver, Colorado, United States
- Danbury Hospital — Danbury, Connecticut, United States
- Holy Cross Hospital Inc — Fort Lauderdale, Florida, United States
- SCRI Florida Cancer Specialists South — Fort Myers, Florida, United States
- Florida Cancer Specialists — Palm Beach Gardens, Florida, United States
- Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
- Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) — St. Petersburg, Florida, United States
- University Cancer & Blood Center, LLC; Research — Athens, Georgia, United States
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital — Carrollton, Georgia, United States
- Central Georgia Cancer Care PC — Macon, Georgia, United States
- Southeastern Regional Medical Center, Inc. — Newnan, Georgia, United States
- University of Chicago — Chicago, Illinois, United States
- Joliet Oncology-Hematology; Associates, Ltd. — Joliet, Illinois, United States
- Quincy Medical Group — Quincy, Illinois, United States
- Fort Wayne Med Oncology & Hematology Inc — Fort Wayne, Indiana, United States
- Hematology-Oncology; Associates of the Quad Cities — Bettendorf, Iowa, United States
- Ironwood Cancer & Research Centers — Chandler, Arizona, United States
Full record on ClinicalTrials.gov
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