A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/7/2019 |
Start Date: | June 7, 2016 |
End Date: | August 1, 2019 |
A Phase I/III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin Plus Etoposide With or Without Atezolizumab (Anti-PD-L1 Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study is
designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1
[PD-L1] antibody) in combination with carboplatin plus (+) etoposide compared with treatment
with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC.
Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin +
etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the
induction phase followed by maintenance with atezolizumab or placebo until progressive
disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid
Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD
or symptomatic deterioration.
designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1
[PD-L1] antibody) in combination with carboplatin plus (+) etoposide compared with treatment
with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC.
Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin +
etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the
induction phase followed by maintenance with atezolizumab or placebo until progressive
disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid
Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD
or symptomatic deterioration.
Inclusion Criteria:
- Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration
Lung Study Group [VALG] staging system)
- No prior systemic treatment for ES-SCLC
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end organ function
- Treatment-free for at least 6 months since last chemo/radiotherapy, among those
treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
Exclusion Criteria:
- Active or untreated central nervous system (CNS) metastases as determined by computed
tomography (CT) or magnetic resonance imaging (MRI) evaluation
- Malignancies other than SCLC within 5 years prior to randomization, with the exception
of those with a negligible risk of metastasis or death treated with expected curative
outcome
- Pregnant or lactating women
- History of autoimmune disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is
permitted.
- Positive test result for human immunodeficiency virus (HIV)
- Active hepatitis B or hepatitis C
- Severe infections at the time of randomization
- Significant cardiovascular disease
- Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint
blockade therapies, anti-programmed death-1 (PD-1), and anti-PD-L1 therapeutic
antibody
- History of severe (or known) hypersensitivity to chimeric or humanized antibodies or
fusion proteins or any component of atezolizumab formulation
We found this trial at
26
sites
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
Fort Myers, Florida 33916
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3730 South Eastern Avenue
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
Marietta, Georgia 30060
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Florida Hospital Florida Hospital is one of the country
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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