Overview

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]

Status:
Completed
Trial end date:
2017-12-18
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genentech, Inc.
Treatments:
Antibodies
Antibodies, Monoclonal
Atezolizumab
Criteria
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