Trilaciclib Prevents Myelosuppression With Chemoradiotherapy

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

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

Study Overview

• Status: Recruiting
• Conditions: Myelosuppression
• Intervention / Treatment: Drug: Trilaciclib

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xinrong Lian; Phone Number: 010-87787692; Email: 15810538030@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
      • Contact: Lei Deng, PhD

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trilaciclib combined with concurrent chemoradiotherapy; Trilaciclib is used simultaneously before the first cycle of chemotherapy during radiotherapy for limited-stage small cell lung cancer	Drug: Trilaciclib; During concurrent chemoradiotherapy in limited-stage small cell lung cancer, Trilaciclib is administered prophylactically before the first cycle of chemotherapy; Other Names: Trilaciclib combined with concurrent chemoradiotherapy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Study Chair: Lei Deng, PhD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2024
• Primary Completion (Estimated): January 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 29, 2024
• First Submitted That Met QC Criteria: June 29, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NCC4382

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No