Trilaciclib Prevents Myelosuppression With Chemoradiotherapy

Phase 2

• Conditions: Myelosuppression
• Interventions: Drug: Trilaciclib

• Registration Number: NCT06490081
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

To evaluate the protective effect of Trilaciclib on myelosuppression in patients with limited-stage small cell lung cancer associated with concurrent chemoradiotherapy and discuss the effect of gut microbiota changes on myelosuppression

Detailed Description

The occurrence of myelosuppression following chemotherapy, including severe neutropenia and hematological toxicity (Grade 3/4), as well as its association with dynamic changes in the gut microbiota, was investigated in conjunction with prophylactic administration of the CDK4/6 inhibitor Trilaciclib prior to the initiation of chemotherapy during radiotherapy for limited stage small cell lung cancer.

Study Timeline

• Study Start: 2024-06-26
• Study First Submitted: 2024-06-29
• Study First Submitted QC: 2024-06-29
• Status Verified: 2024-07
• Study First Posted: 2024-07-08
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-16
• Primary Completion: 2026-01-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. The histopathology is limited-stage small cell lung cancer.
2. ECOG score 0-2.
3. Good organ function (no blood transfusions, no hematopoietic stimulating factors, no transfusions of albumin or blood products within 14 days prior to the examination).
4. It is suitable for patients treated with Trilaciclib combined with etoposide plus cisplatin or carboplatin.
5. Understand and can sign informed consent

Exclusion Criteria

1. Brain metastases with clinical symptoms require local radiotherapy or hormone therapy.
2. Active infections require systemic treatment.
3. Subjects with active, known or suspected autoimmune disease or history of autoimmune disease.
4. Combined with other tumors.
5. The current or previous presence of a clinically significant and medically unstable condition, which in the investigator's professional judgment may compromise subject safety, interfere with study evaluation or endpoint assessment, or otherwise impact the reliability of study results.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trilaciclib combined with concurrent chemoradiotherapy	Trilaciclib	Trilaciclib is used simultaneously before the first cycle of chemotherapy during radiotherapy for limited-stage small cell lung cancer

Primary Outcome Measures

Name	Time	Method
Occurrence of severe neutropenia	14 days	Grade 3/4 decline in neutropenia after the first cycle of chemotherapy during radiotherapy
Duration of severe neutropenia	5 days	Duration of severe neutropenia after the first cycle of chemotherapy during radiotherapy (ANC\<1.0×10\^9/L for more than 5 days)
Occurrence of hematological toxicity	5 days	Grade 3/4 decline in neutrophils, platelets, and red blood cells

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China