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]

  • Non-Small Cell Lung Cancer
Trial Status:

Completed

This trial runs in
Countries
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Mexico
  • Netherlands
  • Peru
  • Portugal
  • Russia
  • Singapore
  • Slovakia
  • Spain
  • Taiwan
  • Ukraine
  • United States
Trial Identifier:

NCT02367794 2014-003208-59 GO29437

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT02367794 , GO29437 , 2014-003208-59 Trial Identifier
      Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody, Carboplatin, Nab-Paclitaxel, Paclitaxel Treatments
      Squamous Non-Small Cell Lung Cancer Condition
      Official Title

      A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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

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