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]
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.
Checked against the public recordLast updated Mar 21, 2022 · 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-programmed death-ligand 1 (anti-PD-L1) antibody; Drug: Carboplatin; Drug: Nab-Paclitaxel; Drug: Paclitaxel
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 (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 Exclusion Criteria: * 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Ironwood Cancer & Research CentersChandler, Arizona
- Highlands Oncology GroupSpringdale, Arkansas
- Southern CA Permanente Med GrpBellflower, California
- Kaiser Permanente Oakland Medical CenterOakland, California
- Kaiser Permanente - Sacramento Medical Center and Medical OfficesSacramento, California
- Kaiser Permanente - San Leandro Medical CenterSan Leandro, California
- Kaiser Permanente - Santa ClaraSanta Clara, California
- Kaiser Permanente; Oncology Clinical TrialsVallejo, California
- Kaiser Permanente - Walnut CreekWalnut Creek, California
- Rocky Mountain Cancer CenterDenver, Colorado
- Danbury HospitalDanbury, Connecticut
- Holy Cross Hospital IncFort Lauderdale, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 21, 2022. Always confirm current availability with the study team.