Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Extensive Stage Small Cell Lung Cancer (SCLC)
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/30/2018 |
Start Date: | April 7, 2017 |
End Date: | May 2020 |
Phase 2 Study of Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib in Patients With Untreated Extensive Stage Small Cell Lung Cancer
This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in
preserving the bone marrow and the immune system, and enhancing antitumor efficacy when
administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line
treatment for patients with newly diagnosed extensive-stage SCLC.
The study is a randomized, double-blinded, placebo-controlled design. The study will include
3 study phases: Screening Phase,Treatment Phase (induction part + maintenance part), and
Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study
treatment and completes at the Post-Treatment Visit. Approximately, 100 patients will be
enrolled in the study.
preserving the bone marrow and the immune system, and enhancing antitumor efficacy when
administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line
treatment for patients with newly diagnosed extensive-stage SCLC.
The study is a randomized, double-blinded, placebo-controlled design. The study will include
3 study phases: Screening Phase,Treatment Phase (induction part + maintenance part), and
Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study
treatment and completes at the Post-Treatment Visit. Approximately, 100 patients will be
enrolled in the study.
Inclusion Criteria:
- Male or female subjects aged ≥18 years
- Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably
including the presence of neuroendocrine features by immunohistochemistry
- At least 1 target lesion that is measurable by RECIST, Version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Adequate organ function
Exclusion Criteria:
- Prior chemotherapy for extensive-stage SCLC
- Prior immunotherapies including but not limited to CD137, anti-PD-1, anti-PD-L1, and
CTLA4.
- Presence of symptomatic brain metastases requiring immediate treatment with radiation
therapy or steroids.
- History of pulmonary fibrosis, organizing pneumonia or pneumonitis on screening chest
CT
- Active, known, suspected autoimmune disease requiring systemic treatment in the past 2
years
- Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart
failure
- Known history of stroke or cerebrovascular accident within 6 months prior to
enrollment
- Other uncontrolled serious chronic disease or conditions that in the investigator's
opinion could affect compliance or follow-up in the protocol
- Concurrent radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment
- Receipt of any investigational medication within 4 weeks prior to enrollment
- Administration of attenuated vaccine within 4 weeks before enrollment
- Systemic treatment with corticosteriods or other immunosuppressive medications within
14 days of study drug administration
We found this trial at
24
sites
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Arlington, Virginia 22205
Principal Investigator: Alexander Spira, MD
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Atlanta, Georgia 30341
Principal Investigator: Rodolfo Bordoni, MD
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Bridgeton, Missouri 63044
Principal Investigator: Juan Cuevas, MD
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Fort Belvoir, Virginia 22060
Principal Investigator: Pramvir S. Verma, MD
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Joliet, Illinois 60435
Principal Investigator: Jason Suh, MD
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Loma Linda University
Loma Linda, California 92354
Loma Linda, California 92354
(909) 558-4000
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Principal Investigator: Hamid Mirshahidi, MD
Loma Linda University Loma Linda University (LLU) is a Seventh-day Adventist educational health-sciences institution with...
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1850 Bluegrass Avenue
Louisville, Kentucky 40215
Louisville, Kentucky 40215
Principal Investigator: Monte Martin, MD
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831 South Broadway Street
Minot, North Dakota 58701
Minot, North Dakota 58701
Principal Investigator: Patanit Watanaboouyakhet, MD
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Morristown, New Jersey 07960
Principal Investigator: Sarada Gurubhagavatula, MD
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Mount Kisco, New York 10549
Principal Investigator: Jonathan Goldberg, MD
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Oklahoma City, Oklahoma 73117
Principal Investigator: Raid Aljumaily, MD
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4921 Parkview Place
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Principal Investigator: Saiama Naheed Waqar, MD
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2020 Santa Monica Boulevard
Santa Monica, California 90404
Santa Monica, California 90404
Principal Investigator: Jonathan Goldman, MD
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3540 Mendocino Avenue
Santa Rosa, California 95403
Santa Rosa, California 95403
Principal Investigator: Ian Churchill Anderson, MD
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3109 Bienville Boulevard
Whittier, California 90603
Whittier, California 90603
Principal Investigator: Eddie Thara, MD
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