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]
Condition: Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody; Carboplatin; Cisplatin; Gemcitabine; Pemetrexed
Intervention description: Atezolizumab 1200 milligram (mg) will be administered as intravenous infusion every 21 days until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).; Carboplatin will be administered as intravenous infusion at a dose of area under the concentration-time curve (AUC) 6 when given in combination with pemetrexed or at a dose of AUC 5 when given in combination with gemcitabine, every 21 days for 4 or 6 cycles as per local standard of care.; Cisplatin will be administered as intravenous infusion at a dose of 75 mg per meter squared (mg/m^2) every 21 days for 4 or 6 cycles as per local standard of care.; Gemcitabine will be administered as intravenous infusion at a dose of 1250 mg/m^2 (in combination with cisplatin) or 1000 mg/m^2 (in combination with carboplatin), on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles as per local standard of care.; Pemetrexed will be administered as intravenous infusion at a dose of 500 mg/m^2 on Day 1 of each 21-day cycle as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Intervention MeSH terms: Carboplatin; Gemcitabine; 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: 572.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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