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

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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.


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
New Orleans, Louisiana 70121
Principal Investigator: Suma Satti, MD
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New Orleans, LA
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Arlington, Virginia 22205
Principal Investigator: Alexander Spira, MD
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Arlington, VA
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Atlanta, Georgia 30318
Principal Investigator: Trevor Feinstein, MD
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Atlanta, GA
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Atlanta, Georgia 30341
Principal Investigator: Rodolfo Bordoni, MD
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from
Atlanta, GA
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Beverly Hills, California 90211
Principal Investigator: David Berz, MD
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from
Beverly Hills, CA
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Blacksburg, Virginia 24060
Principal Investigator: Jerome H Goldschmidt, MD
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from
Blacksburg, VA
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Bridgeton, Missouri 63044
Principal Investigator: Juan Cuevas, MD
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from
Bridgeton, MO
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Burgas,
Principal Investigator: Krasimir Nikolov, MD
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Burgas,
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Fort Belvoir, Virginia 22060
Principal Investigator: Pramvir S. Verma, MD
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from
Fort Belvoir, VA
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Fullerton, California 92835
Principal Investigator: William Lawler, MD
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from
Fullerton, CA
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Houston, Texas 77090
Principal Investigator: Anirudha Dasgupta, MD
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from
Houston, TX
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Joliet, Illinois 60435
Principal Investigator: Jason Suh, MD
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from
Joliet, IL
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Lafayette, Indiana 47905
Principal Investigator: Wael A. Harb, MD
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from
Lafayette, IN
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Loma Linda University
Loma Linda, California 92354
(909) 558-4000
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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Loma Linda, CA
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1850 Bluegrass Avenue
Louisville, Kentucky 40215
Principal Investigator: Monte Martin, MD
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from
Louisville, KY
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831 South Broadway Street
Minot, North Dakota 58701
Principal Investigator: Patanit Watanaboouyakhet, MD
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from
Minot, ND
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Morristown, New Jersey 07960
Principal Investigator: Sarada Gurubhagavatula, MD
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from
Morristown, NJ
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Mount Kisco, New York 10549
Principal Investigator: Jonathan Goldberg, MD
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from
Mount Kisco, NY
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Oklahoma City, Oklahoma 73117
Principal Investigator: Raid Aljumaily, MD
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from
Oklahoma City, OK
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4921 Parkview Place
Saint Louis, Missouri 63110
Principal Investigator: Saiama Naheed Waqar, MD
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from
Saint Louis, MO
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2020 Santa Monica Boulevard
Santa Monica, California 90404
Principal Investigator: Jonathan Goldman, MD
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from
Santa Monica, CA
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3540 Mendocino Avenue
Santa Rosa, California 95403
Principal Investigator: Ian Churchill Anderson, MD
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from
Santa Rosa, CA
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Spartanburg, South Carolina 29303
Principal Investigator: Caio Rocha-Lima, MD
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from
Spartanburg, SC
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3109 Bienville Boulevard
Whittier, California 90603
Principal Investigator: Eddie Thara, MD
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from
Whittier, CA
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