Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06490081

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location status: Recruiting

Location contact

Lei Deng, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Trilaciclib

Drug

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

Primary outcomes

  1. Occurrence of severe neutropenia

    Time frame: 14 days

    Grade 3/4 decline in neutropenia after the first cycle of chemotherapy during radiotherapy

  2. Duration of severe neutropenia

    Time frame: 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)

  3. Occurrence of hematological toxicity

    Time frame: 5 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xinrong Lian

CONTACT

[email protected]

010-87787692

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.