Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy
This was a study to investigate the potential clinical benefit of trilaciclib (G1T28), a Cyclin Dependent Kinase (CDK) 4/6 inhibitor, in preserving the bone marrow and the immune system, in order to decrease chemotherapy-induced myelosuppression and improve anti-tumor efficacy when administered prior to topotecan in patients previously treated for extensive-stage SCLC. The study consisted of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts included 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase began on the day of first dose with study treatment and completes at the Post-Treatment Visit.
Checked against the public recordLast updated Sep 25, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- G1 Therapeutics, Inc.
- Interventions being studied
- Drug: Trilaciclib; Drug: Placebo; Drug: Topotecan
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Key Inclusion Criteria: * Male or female subjects aged ≥18 years * Confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry * Progression during or after prior first- or second-line chemotherapy and eligible to receive topotecan therapy * 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 Key Exclusion Criteria: * Presence of 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 * Receipt of any systemic chemotherapy regimen within 4 weeks prior to enrollment or a noncytotoxic investigational medication within 2 weeks prior to enrollment * History of topotecan treatment for SCLC
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
- Compassionate Cancer Care Medical Group, Inc.Corona, California
- Sutter Medical GroupSacramento, California
- The Oncology Institute of Hope and InnovationWhittier, California
- Memorial Hospital - University of Colorado HealthColorado Springs, Colorado
- Rocky Mountain Cancer CentersDenver, Colorado
- University of Colorado Health, Oncology Clinical Research Northern RegionFort Collins, Colorado
- Florida Cancer Specialists - SouthFort Myers, Florida
- Florida Cancer Specialists - NorthTavares, Florida
- University Cancer and Blood Center, LLCAthens, Georgia
- Emory UniversityAtlanta, Georgia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 25, 2025. Always confirm current availability with the study team.