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)
Condition: Carcinoma, Non-Squamous Non-Small Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Carboplatin; Nab-Paclitaxel; Pemetrexed
Intervention description: Atezolizumab was administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Atezolizumab was administered to participants who were randomized to "Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin)" and to participants in "Arm B (Nab-Paclitaxel + Carboplatin)" who cross over at progression.; Carboplatin was administered at area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.; Nab-paclitaxel was administered as IV infusion at a dose of 100 milligrams per square meter (mg/m^2) on Days 1, 8, and 15 of each 21-day cycle.; Switch maintenance to pemetrexed can be administered within 6 weeks of Day 1 of the last induction cycle.
Intervention MeSH terms: Paclitaxel; Carboplatin; Pemetrexed; Atezolizumab; Antibodies; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 723.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        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