Lung Cancer Clinical Trial
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]
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:
Participants with no prior chemotherapy for advanced disease;
Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants);
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:
who will not receive prior chemotherapy for advanced disease
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
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There are 29 Locations for this study
Scottsdale Arizona, 85258, United States
Palo Alto California, 94304, United States
Santa Monica California, 90025, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06510, United States
Washington District of Columbia, 20007, United States
Orlando Florida, 32804, United States
Port Saint Lucie Florida, 34952, United States
Saint Petersburg Florida, 33705, United States
Tampa Florida, 33612, United States
Carrollton Georgia, 30117, United States
Chicago Illinois, 60637, United States
Lebanon New Hampshire, 03756, United States
New York New York, 10065, United States
Durham North Carolina, 27710, United States
Huntersville North Carolina, 28078, United States
Columbus Ohio, 43210, United States
Hamilton Ohio, 45103, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19104, United States
Nashville Tennessee, 37203, United States
Salt Lake City Utah, 84112, United States
Richmond Virginia, 23226, United States
Seattle Washington, 98195, United States
Wilrijk , 2610, Belgium
Lyon , 69008, France
Amsterdam , 1066 , Netherlands
London , EC1M , United Kingdom
London , SW3 6, United Kingdom
London , SW3 6, United Kingdom
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