CompletedPhase 3NCT02367781

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

StatusCompleted
PhasePhase 3
U.S. locations132
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-PD-L1 antibody; Drug: Carboplatin; Drug: Nab-Paclitaxel; Drug: Pemetrexed
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 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.

04
Study sites

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.

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