A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
Condition: Small Cell Lung Carcinoma
MeSH terms: Small Cell Lung Carcinoma
Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Carboplatin; Etoposide; Placebo
Intervention description: Atezolizumab intravenous infusion was administered at a dose of 1200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).; Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).; Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4).; Placebo intravenous infusion was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).
Intervention MeSH terms: Carboplatin; Etoposide; Atezolizumab; Antibodies; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 503.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was
      designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1
      [PD-L1] antibody) in combination with carboplatin plus (+) etoposide compared with treatment
      with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC.
      Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin +
      etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the
      induction phase followed by maintenance with atezolizumab or placebo until progressive
      disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid
      Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD
      or symptomatic deterioration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration
             Lung Study Group [VALG] staging system)

          -  No prior systemic treatment for ES-SCLC

          -  Eastern Cooperative Oncology Group performance status of 0 or 1

          -  Measurable disease, as defined by RECIST v1.1

          -  Adequate hematologic and end organ function

          -  Treatment-free for at least 6 months since last chemo/radiotherapy, among those
             treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC

        Exclusion Criteria:

          -  Active or untreated central nervous system (CNS) metastases as determined by computed
             tomography (CT) or magnetic resonance imaging (MRI) evaluation

          -  Malignancies other than SCLC 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 result for human immunodeficiency virus (HIV)

          -  Active hepatitis B or hepatitis C

          -  Severe infections at the time of randomization

          -  Significant cardiovascular disease

          -  Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint
             blockade therapies, anti-programmed death-1 (PD-1), and anti-PD-L1 therapeutic
             antibody

          -  History of severe (or known) hypersensitivity to chimeric or humanized antibodies or
             fusion proteins or any component of atezolizumab formulation.