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
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Kavitha Ramchandran
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

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