A Study of Atezolizumab in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) [FIR]
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Intervention description: Atezolizumab 1200 mg IV on Day 1 of each 21-day cycle until disease progression.
Intervention MeSH terms: Atezolizumab; Antibodies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab
      (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC.
      Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab
      (MPDL3280A) on Day 1 of 21-day cycles until disease progression.

      Eligible participants will be categorized in to three groups as follows:

        1. Participants with no prior chemotherapy for advanced disease;

        2. Participants who progress during or following a prior-platinum based chemotherapy
           regimen for advanced disease (2L+participants);

        3. Participants who are 2L+ and previously treated for brain metastases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent
             NSCLC

          -  PDL1-positive status as determined by an immunohistochemistry assay performed by a
             central laboratory. A positive result in chemotherapy, chemoradiation of the tumor
             sample biopsy will satisfy the eligibility criterion

          -  Eastern Cooperative Oncology group Performance Status of 0 or 1

          -  Life expectancy greater than or equal to 12 weeks

          -  Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors Version
             1.1

          -  Adequate hematologic and end organ function

        Exclusion Criteria:

          -  Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3
             weeks prior to initiation of study treatment; the following exceptions are allowed.
             Hormone-replacement therapy or oral contraceptives, and tyrosine kinase inhibitors
             approved for treatment of NSCLC discontinued greater than 7 days prior to Cycle 1 Day
             1

          -  Treatment with any other investigational agent or participation in another clinical
             trial with therapeutic intent within 28 days prior to enrollment

          -  Known central nervous system disease, including treated brain metastases in the
             following participants:

               1. who will not receive prior chemotherapy for advanced disease

               2. who progress during or following a prior-platinum based chemotherapy regimen for
                  advanced disease (referred as 2L+ participants)

          -  Participants with a history of treated asymptomatic brain metastases are allowed in
             the 2L+ participants and previously treated for brain metastases.

          -  Leptomeningeal disease

          -  Uncontrolled tumor-related pain

          -  Uncontrolled hypercalcemia