Status:
COMPLETED
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]
Lead Sponsor:
Genentech, Inc.
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2017
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT01846416
Start Date
May 30 2013
End Date
December 18 2017
Last Update
January 8 2019
Active Locations (31)
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1
HonorHealth Research Institute - Pima Center
Scottsdale, Arizona, United States, 85258
2
Stanford University/Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
3
The Angeles Clinic and Research Institute, Santa Monica Office
Santa Monica, California, United States, 90025
4
University Of Colorado
Aurora, Colorado, United States, 80045