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 |
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.
(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
Scottsdale, Arizona 85258
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
Port Saint Lucie, Florida 34952
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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9801 Kincey Avenue
Huntersville, North Carolina 28078
Huntersville, North Carolina 28078
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
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
Santa Monica, California 90025
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Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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