A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Atezolizumab; Carboplatin; Cisplatin; Pemetrexed
Intervention description: Participants received IV infusion of 1200 mg atezolizumab on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.; Participants received IV infusion of carboplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period with doses calculated using Calvart formula.; Participants received IV infusion of 75 mg/m^2 cisplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period.; Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.
Intervention MeSH terms: Carboplatin; Pemetrexed; Atezolizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 578.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, Phase III, multicenter, open-label study designed to evaluate the
      safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed
      compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are
      chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be
      randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin +
      Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in
      two phases: Induction Phase and Maintenance Phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Histologically or cytologically confirmed, Stage IV non-squamous NSCLC. Participants
             with tumors of mixed non-small cell histology (i.e., squamous and non-squamous) are
             eligible if the major histological component appears to be non-squamous

          -  No prior treatment for Stage IV non-squamous NSCLC. Participants with a sensitizing
             mutation in the epidermal growth factor receptor (EGFR) gene or with an anaplastic
             lymphoma kinase (ALK) fusion oncogene are excluded. Participants with unknown EGFR and
             ALK status require test results at screening from a local or central laboratory

          -  Participants who have received prior neo-adjuvant, radiotherapy, adjuvant
             chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease
             must have experienced a treatment-free interval of at least 6 months from
             randomization since the last dose of chemotherapy and/or radiotherapy

          -  Participants should submit a pre-treatment tumor tissue sample if available before or
             within 4 weeks after enrollment. If tumor tissue is not available, participants are
             still eligible

          -  For participants enrolled in the extended China enrollment phase: current resident of
             mainland China, Hong Kong, or Taiwan and of Chinese ancestry

          -  Measurable disease, as defined by RECIST v1.1

          -  Adequate hematologic and end organ function

          -  For women of childbearing potential: agreement to remain abstinent or use
             contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per
             year during the treatment period and for at least 5 months after the last dose of
             atezolizumab or 6 months after the last dose of cisplatin

          -  For men: agreement to remain abstinent or use contraceptive measures and agreement to
             refrain from donating sperm

        Exclusion Criteria:

        Cancer-Specific Exclusions

          -  Participants with a sensitizing mutation in the EGFR gene or an ALK fusion oncogene

          -  Active or untreated central nervous system (CNS) metastases as determined by computed
             tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and
             prior radiographic assessments

          -  Spinal cord compression not definitively treated with surgery and/or radiation or
             previously diagnosed and treated spinal cord compression without evidence that disease
             has been clinically stable for greater than or equal to (>= 2) weeks prior to
             randomization

          -  Leptomeningeal disease

          -  Uncontrolled tumor-related pain

          -  Uncontrolled or symptomatic hypercalcemia (greater than [>] 1.5 millimole/Liter
             ionized calcium or calcium >12 milligrams/deciliter or corrected serum calcium >upper
             limit of normal)

          -  Malignancies other than NSCLC within 5 years prior to randomization

          -  Known tumor programmed death-ligand 1 (PD-L1) expression status from other clinical
             studies (e.g., participants whose PD-L1 expression status was determined during
             screening for entry into a study with anti-PD-1 or anti-PD L1 antibodies but were not
             eligible are excluded)

        General Medical Exclusions:

          -  History of severe allergic, anaphylactic, or other hypersensitivity reactions to
             chimeric or humanized antibodies or fusion proteins

          -  History of certain autoimmune disease

          -  History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
             pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis

          -  All participants will be tested for human immunodeficiency virus (HIV) prior to the
             inclusion into the study and HIV-positive participants will be excluded from the
             clinical study

          -  Severe infections within 4 weeks prior to randomization

          -  Significant cardiovascular disease, such as New York Heart Association cardiac disease
             (Class II or greater), myocardial infarction or cerebrovascular accident within 3
             months prior to randomization, unstable arrhythmias, or unstable angina

          -  Illness or condition that may interfere with a participant's capacity to understand,
             follow, and/or comply with study procedures

        Exclusion Criteria Related to Medications and Chemotherapy:

          -  Prior treatment with EGFR inhibitors or ALK inhibitors

          -  Any approved anti-cancer therapy, including hormonal therapy within 21 days prior to
             initiation of study treatment

          -  Prior treatment with cluster of differentiation 137 (CD137) agonists or immune
             checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies

          -  Treatment with systemic immunostimulatory agents within 4 weeks prior to randomization

          -  Treatment with systemic immunosuppressive medications

        Exclusion Criteria Related to Chemotherapy:

          -  History of allergic reactions to cisplatin, carboplatin, or other platinum-containing
             compounds

          -  Participants with hearing impairment (cisplatin)

          -  Grade >=2 peripheral neuropathy as defined by National Cancer Institute Common
             Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria (cisplatin)

          -  Creatinine clearance (CRCL) <60 milliliters/minute (mL/min) for cisplatin or <45
             mL/min for carboplatin