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]
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.
Checked against the public recordLast updated Jan 8, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Genentech, Inc.
- Interventions being studied
- Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- HonorHealth Research Institute - Pima CenterScottsdale, Arizona
- Stanford University/Lucile Packard Children's HospitalPalo Alto, California
- The Angeles Clinic and Research Institute, Santa Monica OfficeSanta Monica, California
- University Of ColoradoAurora, Colorado
- Yale University School Of MedicineNew Haven, Connecticut
- Georgetown UniversityWashington D.C., District of Columbia
- Florida Hospital Cancer InstOrlando, Florida
- Hematology Oncology Associates of the Treasure CoastPort Saint Lucie, Florida
- Florida Cancer Specialists.St. Petersburg, Florida
- H. Lee Moffitt Cancer Center and Research Inst.Tampa, Florida
- Northwest Georgia Oncology Centers P.C.Carrollton, Georgia
- The University of Chicago Medical CenterChicago, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 8, 2019. Always confirm current availability with the study team.