Trilaciclib Prevents Myelosuppression With Chemoradiotherapy

NCT06490081 | Recruiting Phase 2

• 1 other identifier: NCC4382
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Myelosuppression

Outcome Measures

Primary Outcomes (3)

• 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

• Occurrence of hematological toxicity

  Grade 3/4 decline in neutrophils, platelets, and red blood cells

  5 days

Study Arms (1)

Trilaciclib combined with concurrent chemoradiotherapy

EXPERIMENTAL

Trilaciclib is used simultaneously before the first cycle of chemotherapy during radiotherapy for limited-stage small cell lung cancer

Drug: Trilaciclib

Interventions

Trilaciclib DRUG

During concurrent chemoradiotherapy in limited-stage small cell lung cancer, Trilaciclib is administered prophylactically before the first cycle of chemotherapy

Also known as: Trilaciclib combined with concurrent chemoradiotherapy

Trilaciclib combined with concurrent chemoradiotherapy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Brain metastases with clinical symptoms require local radiotherapy or hormone therapy.
• Active infections require systemic treatment.
• Subjects with active, known or suspected autoimmune disease or history of autoimmune disease.
• Combined with other tumors.
• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Interventions

trilaciclib; Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Lei Deng, PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Xinrong Lian

CONTACT

010-87787692; 15810538030@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 8, 2024
• Study Start: June 26, 2024
• Primary Completion: January 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 24, 2024

Record last verified: 2024-07

Locations

CN (1)