Trilaciclib Prevents Myelosuppression With Chemoradiotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-26

Study Completion Date

2026-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Myelosuppression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trilaciclib combined with concurrent chemoradiotherapy

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

Group Type EXPERIMENTAL

Trilaciclib

Intervention Type DRUG

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

Interventions

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Trilaciclib

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

Intervention Type DRUG

Other Intervention Names

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Trilaciclib combined with concurrent chemoradiotherapy

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No