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]

• Status: Completed
• Trial end date: 2017-12-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Atezolizumab

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