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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]
Not Recruiting
Trial ID: NCT01846416
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
Stanford Investigator(s)
Heather Wakelee
Winston Chen and Phyllis Huang Professor
Joel Neal, MD, PhD
Associate Professor of Medicine (Oncology)
Kavitha Ramchandran
Clinical Professor, Medicine - Oncology
Eligibility
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
Intervention(s):
drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061