Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC)
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 21, 2020 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- G1 Therapeutics, Inc.
- Interventions being studied
- Drug: Carboplatin; Drug: Placebo; Drug: Trilaciclib; Drug: Etoposide
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Genesis Cancer CenterHot Springs, Arkansas
- Highlands Oncology GroupRogers, Arkansas
- The Oncology Institute of Hope and InnovationWhittier, California
- Memorial Hospital - Univ. of Colorado HealthColorado Springs, Colorado
- University of Colorado Health, Oncology Clinical Research Northern RegionFort Collins, Colorado
- Boca Raton Regional Hospital - Lynn Cancer InstituteBoca Raton, Florida
- Florida Cancer Specialists - SouthFort Myers, Florida
- Florida Cancer Specialists - NorthTavares, Florida
- Florida Cancer Specialists - EastWest Palm Beach, Florida
- University Cancer and Blood Center, LLCAthens, Georgia
- Emory UniversityAtlanta, Georgia
- Norton Cancer InstituteLouisville, Kentucky
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 21, 2020. Always confirm current availability with the study team.