A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]

  • Non-Small Cell Lung Cancer
Trial Status:

Active, not recruiting

This trial runs in
Countries
  • Brazil
  • China
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Japan
  • Korea, Republic of
  • Poland
  • Romania
  • Russian Federation
  • Serbia
  • Spain
  • Thailand
  • Turkey
  • Ukraine
  • United Kingdom
  • United States
Trial Identifier:

NCT02409342 2014-003083-21 GO29431

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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 efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT02409342 , GO29431 , 2014-003083-21 Trial Identifier
      Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody, Carboplatin, Cisplatin, Gemcitabine, Pemetrexed Treatments
      Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer Condition
      Official Title

      A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous Or Squamous Non-Small Cell Lung Cancer

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC
      • No prior treatment for Stage IV non-squamous or squamous NSCLC. Participant known to have a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene are excluded from the study
      • Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
      • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
      • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
      • Adequate hematologic and end-organ function
      Exclusion Criteria
      • Known sensitizing mutation in the EGFR gene or ALK fusion oncogene
      • Active or untreated central nervous system (CNS) metastases as determined by Computed Tomography (CT) or magnetic resonance imaging (MRI) evaluation
      • 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 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 (CD) 137 agonists or immune checkpoint blockade therapies, anti PD1, and anti-PD-L1 therapeutic antibody
      • Severe infection within 4 weeks prior to randomization
      • Significant history of cardiovascular disease

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