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Clinical Trials in China / NCT06370416
Enrolling by invitation Phase 2

the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib

NCT06370416 · tracked via the Priya Life Science China tracker
Sponsor
Henan Cancer Hospital
Phase
Phase 2
Started
2024-04-02
Last updated
2026-01-28

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Trilaciclib

Trilaciclib: After pathological diagnosis of NSCLC, 40 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of trilaciclib before chemotherapy, after signing informed consent.

Study summary

This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of tralazili before chemotherapy in patients with NSCLC.After pathological diagnosis of non-small cell lung cancer(NSCLC), 40 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of trilaciclib before chemotherapy, after signing informed consent.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years old, regardless of gender; * Patients with locally advanced and late stage (IIIB, IIIC, IV) NSCLC who have been confirmed by histopathology and cannot be surgically removed (without local symptoms (with or without brain metastasis)) have at least one measurable lesion that meets the RECIST 1.1 criteria * Need to receive chemotherapy treatment (first-line chemotherapy treatment uses platinum+pemetrexed/docetaxel/albumin paclitaxel/paclitaxel; second-line chemotherapy treatment: choose the above first-line chemotherapy treatment without using chemotherapy drugs; (Note: If first-line chemotherapy treatment does not combine with immunotherapy, subsequent increase in immunotherapy patients will not be counted as an increase in the number of treatment lines, and the number of treatment lines in this trial is limited to the number of chemotherapy treatment lines) * The laboratory inspection meets the standards * ECOG PS score 0-1 points; * Women: All women with potential fertility must have a negative serum pregnancy test result during the screening period, and reliable contraceptive measures must be taken 3 months after signing the informed consent form and the last dose; * Understand and sign the informed consent form. Exclusion Criteria: * Diagnosed as other malignant diseases other than NSCLC within 5 years prior to initial administration (excluding curative basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curative resection of carcinoma in situ); * Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA grade III or IV); * Stroke or cardiovascular events within 6 months prior to enrollment * When screening, QTcF interval\>480msec, for patients with implanted ventricular pacemakers, QTcF\>500msec * Previously received hematopoietic stem cell or bone marrow transplantation * Allergy to the investigational drug or its components; * The researchers believe that it is not suitable to participate in this study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Henan Tumor Hospital Zhengzhou Henan

More Henan Cancer Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06370416 on ClinicalTrials.gov ↗ ← All trials in China