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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

138

Study ID:

NCT01846416

Recruitment Status:

Completed

Sponsor:

Genentech, Inc.

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There are 29 Locations for this study

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HonorHealth Research Institute - Pima Center
Scottsdale Arizona, 85258, United States
Stanford University/Lucile Packard Children's Hospital
Palo Alto California, 94304, United States
The Angeles Clinic and Research Institute, Santa Monica Office
Santa Monica California, 90025, United States
University Of Colorado
Aurora Colorado, 80045, United States
Yale University School Of Medicine
New Haven Connecticut, 06510, United States
Georgetown University
Washington District of Columbia, 20007, United States
Florida Hospital Cancer Inst
Orlando Florida, 32804, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie Florida, 34952, United States
Florida Cancer Specialists.
Saint Petersburg Florida, 33705, United States
H. Lee Moffitt Cancer Center and Research Inst.
Tampa Florida, 33612, United States
Northwest Georgia Oncology Centers P.C.
Carrollton Georgia, 30117, United States
The University of Chicago Medical Center
Chicago Illinois, 60637, United States
Dartmouth Hitchcock Med Center; Norris Cotton Cancer Ctr
Lebanon New Hampshire, 03756, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Duke University Health Systems
Durham North Carolina, 27710, United States
Carolina BioOncology Institute; Can Therapy & Res Ctr
Huntersville North Carolina, 28078, United States
Ohio State Uni Hospital
Columbus Ohio, 43210, United States
Oncology Hematology Care, Inc.
Hamilton Ohio, 45103, United States
Penn State Univ. Milton S. Hershey Medical Center; MSHMC Cardiology
Hershey Pennsylvania, 17033, United States
Penn Presbyterian Medical Center; Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
SCRI-Tennessee Oncology
Nashville Tennessee, 37203, United States
Huntsman Cancer Institute; University of Utah
Salt Lake City Utah, 84112, United States
Virginia Cancer Institute
Richmond Virginia, 23226, United States
University of Washington Seattle Cancer Care Alliance
Seattle Washington, 98195, United States
Sint Augustinus Wilrijk
Wilrijk , 2610, Belgium
Centre Léon Bérard
Lyon , 69008, France
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam , 1066 , Netherlands
Queen Mary University of London
London , EC1M , United Kingdom
Royal Marsden Hospital - Fulham; Oncology Department
London , SW3 6, United Kingdom
Royal Marsden Hospital - Fulham
London , SW3 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

138

Study ID:

NCT01846416

Recruitment Status:

Completed

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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