Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC)

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Small Cell Lung Cancer

In brief

This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and etoposide in first line treatment for patients with newly diagnosed extensive-stage SCLC. The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, 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, 90 patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part 2 portion.

Key facts

Study ID

NCT02499770

Run by

G1 Therapeutics, Inc.

People needed

122

Starts

2015-06-26

Expected to finish

2019-02-22

Last updated by the study team

2020-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 unirradiated and measurable by RECIST, Version 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
• Adequate organ function

You may not qualify if…

• Prior chemotherapy for extensive-stage SCLC
• Presence of symptomatic brain metastases requiring immediate treatment with radiation therapy or steroids.
• 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 or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
• Receipt of any investigational medication within 4 weeks prior to enrollment

Where it is running

• Genesis Cancer Center — Hot Springs, Arkansas, United States
• Highlands Oncology Group — Rogers, Arkansas, United States
• The Oncology Institute of Hope and Innovation — Whittier, California, United States
• Memorial Hospital - Univ. of Colorado Health — Colorado Springs, Colorado, United States
• University of Colorado Health, Oncology Clinical Research Northern Region — Fort Collins, Colorado, United States
• Boca Raton Regional Hospital - Lynn Cancer Institute — Boca Raton, Florida, United States
• Florida Cancer Specialists - South — Fort Myers, Florida, United States
• Florida Cancer Specialists - North — Tavares, Florida, United States
• Florida Cancer Specialists - East — West Palm Beach, Florida, United States
• University Cancer and Blood Center, LLC — Athens, Georgia, United States
• Emory University — Atlanta, Georgia, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Center For Cancer and Blood Disorders — Bethesda, Maryland, United States
• Norris Cotton Cancer Center — Lebanon, New Hampshire, United States
• University of New Mexico Comprehensive Cancer Center — Albuquerque, New Mexico, United States
• Roswell Park — Buffalo, New York, United States
• UNC - Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Oklahoma University - Peggy and Charles Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Guthrie Medical Group, PC — Sayre, Pennsylvania, United States
• Greenville Health System — Greenville, South Carolina, United States
• Gibbs Cancer Center — Spartanburg, South Carolina, United States
• Tennessee Cancer Specialists — Knoxville, Tennessee, United States
• Hanna Cancer Associates - University of Tennessee — Knoxville, Tennessee, United States
• Texas Oncology — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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