Clinical trial

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

Name

NCC4382

Description

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

Trial arms

Trial start

2024-06-26

Estimated PCD

2026-01-30

Trial end

2026-06-30

Phase

Early phase I

Treatment

Trilaciclib

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

Arms:

Trilaciclib combined with concurrent chemoradiotherapy

Other names:

Trilaciclib combined with concurrent chemoradiotherapy

Size

Primary endpoint

Severe neutropenia

5 days

Occurrence of hematological toxicity

5 days

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2024-07-08

1 organization

1 drug

1 indication

Organization

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Drug

Trilaciclib

Indication

Myelosuppression