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
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/10/2019
Start Date:May 30, 2013
End Date:December 18, 2017

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A Phase II, Multicenter, Single-arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer

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.


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
We found this trial at
26
sites
8850 East Pima Center Parkway
Scottsdale, Arizona 85258
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
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Aurora, Colorado 80045
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Carrollton, Georgia 30117
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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410 West 10th Avenue
Columbus, Ohio 43210
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Durham, North Carolina 27710
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2055 Hospital Drive
Hamilton, Ohio 45103
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Hershey, PA
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9801 Kincey Avenue
Huntersville, North Carolina 28078
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Lebanon, NH
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Nashville, Tennessee 37203
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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2501 North Orange Avenue
Orlando, Florida 32804
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Palo Alto, CA
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Richmond, Virginia 23235
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Saint Petersburg, Florida 33705
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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11818 Wilshire Boulevard
Santa Monica, California 90025
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Seattle, WA
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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24 Oosterveldlaan
Wilrijk, 2610
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