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]
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
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.
Official Title
A Phase II, Multicenter, Single-arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
Eligibility 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
- * 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov
