Trilaciclib in Combination With Chemotherapy in Patients With CDK4/6-Dependent Solid Tumors

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

Trilaciclib, an innovative first-in-class therapy that protects bone marrow at the source, has been approved for use in CDK4/6-independent small-cell lung cancer. However, clinical practice shows that patients with solid tumors frequently experience treatment-related pancytopenia involving neutrophils, erythroid lineage, and platelets after antineoplastic therapy, with a particularly high incidence of grade 3-4 myelosuppression. This poses serious threats to patient safety and delays the timely, standard administration of anticancer treatments. Therefore, it is imperative to investigate the expansion of trilaciclib's indications to solid tumors and its underlying mechanisms, and to establish a primary prophylaxis prediction model for solid tumor patients receiving chemotherapy.

This study is designed in three parts:

1. Retrospective study: Collect real-world clinical data from patients with solid tumors who received trilaciclib for bone marrow protection during antineoplastic therapy, identify relevant multifactorial determinants, and use statistical methods to develop Primary Prophylaxis Prediction Model A.
2. Prospective study: Based on Model A, patients will be allocated into two experimental cohorts. Experimental Cohort 1: patients for whom primary prophylaxis with trilaciclib is indicated per Model A will receive primary prophylactic treatment. Experimental Cohort 2: patients for whom primary prophylaxis with trilaciclib is not indicated per Model A will receive secondary prophylaxis according to protocol. Outcomes will include the incidence of grade 3-4 myelosuppression, factors potentially influencing trilaciclib's marrow-protective effect, objective response rate (ORR) and progression-free survival (PFS) over 4-6 cycles, and changes in immunologic parameters.
3. Mechanistic exploration: Factors identified by the prediction model as influencing the need for trilaciclib primary prophylaxis will serve as mechanistic targets. Through in vivo and in vitro experiments using flow cytometry and single-cell sequencing, we will validate trilaciclib's bone marrow-protective effects across animal models of solid tumors with varying CDK4/6 dependence, and assess changes in tumor efficacy endpoints, T-lymphocyte subsets, and tumor immune microenvironment markers following trilaciclib monotherapy or combination with standard anticancer regimens.

Study Overview

• Status: Recruiting
• Conditions: Trilaciclib; CDK4/6-dependent Solid Tumors
• Intervention / Treatment: Drug: Trilaciclib group

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050300
      • Recruiting
      • The Fourth Hospital of Hebei Medical University
      • Contact: JIAN SHI, PhD; Phone Number: 0311 - 86095588; Email: shijian6668@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trilaciclib+chemotherapy	Drug: Trilaciclib group; Trilaciclib+chemotherapy
No Intervention: chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of grade 3-4 myelosuppression	Within 4 weeks after completion of chemotherapy

Collaborators and Investigators

• Sponsor: Hebei Medical University Fourth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: G1T28-T-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No