CompletedPhase 3NCT02367794

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

StatusCompleted
PhasePhase 3
U.S. locations242
SponsorHoffmann-La Roche
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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