A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).
Checked against the public recordLast updated Aug 9, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Hoffmann-La Roche
- Interventions being studied
- Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Drug: Carboplatin; Drug: Nab-Paclitaxel; Drug: Pemetrexed
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Eastern Cooperative Oncology Group performance status of 0 or 1 * Histologically or cytologically confirmed, Stage IV non-squamous NSCLC * Participants with no prior treatment for Stage IV non-squamous NSCLC * Previously obtained archival tumor tissue or tissue obtained from fresh biopsy at screening * Measurable disease, as defined by RECIST v1.1 * Adequate hematologic and end organ function Exclusion Criteria: Cancer-Specific Exclusions: * Active or untreated central nervous system metastases * 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 General Medical Exclusions: * 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 scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted * Positive test for human immunodeficiency virus * Active hepatitis B or hepatitis C * Severe infection within 4 weeks prior to randomization * Significant cardiovascular disease * Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures Exclusion Criteria Related to Medications: * Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Highlands Oncology GroupSpringdale, Arkansas
- Kaiser Permanente Oakland Medical CenterOakland, California
- Kaiser Permanente Medical Center - RosevilleRoseville, California
- Kaiser Permanente - Sacramento Medical Center and Medical OfficesSacramento, California
- Kaiser Permanente - San Francisco Medical CenterSan Francisco, California
- Kaiser Permanente - San Jose Medical CenterSan Jose, California
- Kaiser Permanente - San Leandro Medical CenterSan Leandro, California
- Kaiser Permanente - Santa ClaraSanta Clara, California
- Kaiser Permanente - South San FranciscoSouth San Francisco, California
- Kaiser Permanente; Oncology Clinical TrialsVallejo, California
- Kaiser Permanente - Walnut CreekWalnut Creek, California
- Banner MD Anderson Cancer CenterGreeley, Colorado
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 9, 2021. Always confirm current availability with the study team.