Lung Cancer Clinical Trial
Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC)
Summary
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.
Eligibility Criteria
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 unirradiated and 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
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
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There are 40 Locations for this study
Hot Springs Arkansas, 71913, United States
Rogers Arkansas, 72758, United States
Whittier California, 90603, United States
Colorado Springs Colorado, 80909, United States
Fort Collins Colorado, 80528, United States
Boca Raton Florida, 33486, United States
Fort Myers Florida, 33916, United States
Tavares Florida, 32778, United States
West Palm Beach Florida, 33401, United States
Athens Georgia, 30607, United States
Atlanta Georgia, 30322, United States
Louisville Kentucky, 40202, United States
Bethesda Maryland, 20817, United States
Lebanon New Hampshire, 03756, United States
Albuquerque New Mexico, 87106, United States
Buffalo New York, 14263, United States
Chapel Hill North Carolina, 27514, United States
Oklahoma City Oklahoma, 73117, United States
Philadelphia Pennsylvania, 19107, United States
Sayre Pennsylvania, 18840, United States
Greenville South Carolina, 29605, United States
Spartanburg South Carolina, 29203, United States
Knoxville Tennessee, 37909, United States
Knoxville Tennessee, 37920, United States
Tyler Texas, 75702, United States
Vancouver Washington, 98684, United States
Rennes , 35033, France
Tbilisi , 0112, Georgia
Farkasgyepu Veszprem, 8582, Hungary
Budapest , 1121, Hungary
Szolnok , 5000, Hungary
Chisinau , 2025, Moldova, Republic of
Olsztyn , 10-35, Poland
Torun , 87-10, Poland
Warszawa , 02-78, Poland
Malaga Andalucia, 29010, Spain
Barcelona , 08041, Spain
Castillón , 12002, Spain
Madrid , 28009, Spain
Madrid , 28040, Spain
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