Trilaciclib plus chemotherapy for CDK4/6-dependent solid tumors
Official title: Exploration of Indications and Establishment of a Primary Prevention Prediction Model for Trilaciclib in Combination With Chemotherapy in Patients With CDK4/6-Dependent Solid Tumors, and Investigation of the Mechanisms of Related Influencing Factors
Run by Hebei Medical University Fourth Hospital · NCT07490236 · Data updated 2026-11-12
This trial will try adding trilaciclib to chemotherapy to protect the bone marrow of people with CDK4/6-dependent solid tumors from severe drops in blood counts.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Hebei Medical University Fourth Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shijiazhuang, Hebei) |
| Status | Recruiting |
| Started | January 1, 2023 |
| Main results expected | August 1, 2027 |
| Study ends | August 1, 2028 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT07490236 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with CDK4/6‑dependent solid tumors who are receiving myelosuppressive chemotherapy and meet the study's Model A criteria for primary prophylaxis.
✕Probably not a fit
Patients whose tumors are not CDK4/6‑dependent, who are not receiving significantly myelosuppressive regimens, or who are ineligible under Model A are unlikely to benefit from trilaciclib in this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 program combines retrospective real‑world data collection with prospective interventional work to study trilaciclib as prophylaxis against chemotherapy‑induced myelosuppression in CDK4/6‑dependent solid tumors. The first part collects clinical outcomes from patients who have already received trilaciclib for bone marrow protection; subsequent parts will use a prediction algorithm (Model A) to guide primary versus secondary prophylactic use. The study will be conducted at a single center and focuses on hematologic safety outcomes, the incidence of grade 3–4 myelosuppression, and building a prediction model to identify patients who most need primary prophylaxis. Findings will inform whether trilaciclib can be extended beyond small‑cell lung cancer into other solid tumor settings.
Why it matters
Potential benefit: If successful, trilaciclib could reduce severe drops in white cells, red cells, and platelets and help patients stay on their planned chemotherapy schedule.
How similar studies have gone: Trilaciclib is already approved to protect bone marrow in small‑cell lung cancer with trials showing reduced myelosuppression there, but its use in other solid tumors remains largely experimental.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients for whom primary prophylaxis with trilaciclib is indicated per Model A will receive primary prophylactic treatment. Exclusion Criteria: * patients for whom primary prophylaxis with trilaciclib is not indicated per Model A will receive secondary prophylaxis according to protocol.
Where it's running
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The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.