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]

Completed · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01846416

Run by

Genentech, Inc.

People needed

138

Starts

2013-05-30

Expected to finish

2017-12-18

Last updated by the study team

2019-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• HonorHealth Research Institute - Pima Center — Scottsdale, Arizona, United States
• Stanford University/Lucile Packard Children's Hospital — Palo Alto, California, United States
• The Angeles Clinic and Research Institute, Santa Monica Office — Santa Monica, California, United States
• University Of Colorado — Aurora, Colorado, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Florida Hospital Cancer Inst — Orlando, Florida, United States
• Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
• Florida Cancer Specialists. — St. Petersburg, Florida, United States
• H. Lee Moffitt Cancer Center and Research Inst. — Tampa, Florida, United States
• Northwest Georgia Oncology Centers P.C. — Carrollton, Georgia, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• Dartmouth Hitchcock Med Center; Norris Cotton Cancer Ctr — Lebanon, New Hampshire, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University Health Systems — Durham, North Carolina, United States
• Carolina BioOncology Institute; Can Therapy & Res Ctr — Huntersville, North Carolina, United States
• Ohio State Uni Hospital — Columbus, Ohio, United States
• Oncology Hematology Care, Inc. — Hamilton, Ohio, United States
• Penn State Univ. Milton S. Hershey Medical Center; MSHMC Cardiology — Hershey, Pennsylvania, United States
• Penn Presbyterian Medical Center; Abramson Cancer Center — Philadelphia, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• SCRI-Tennessee Oncology — Nashville, Tennessee, United States
• Huntsman Cancer Institute; University of Utah — Salt Lake City, Utah, United States
• Virginia Cancer Institute — Richmond, Virginia, United States
• University of Washington Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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