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
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
Click here to add this to my saved trials
1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
Port Saint Lucie, Florida 34952
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
9801 Kincey Avenue
Huntersville, North Carolina 28078
Huntersville, North Carolina 28078
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
Click here to add this to my saved trials
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
11818 Wilshire Boulevard
Santa Monica, California 90025
Santa Monica, California 90025
Click here to add this to my saved trials
8850 East Pima Center Parkway
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
Click here to add this to my saved trials
Click here to add this to my saved trials