NCT06370416

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

A Single Arm, Exploratory Clinical Study on the Prevention of Bone Marrow Suppression Caused by Platinum Containing Chemotherapy in Advanced Non-small Cell Lung Cancer With Trilaciclib

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of tralazili before chemotherapy in patients with non-small cell lung cancer(NSCLC).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.Record the dynamic changes in whole blood cell count; Hematological toxicity, including febrile neutropenia and associated infections; Blood product infusion and supplementation of hematopoietic raw materials; The use of hematopoietic growth factors; Systemic use of antibiotics; Score the EQ-5D-5L, FACT-L, and FACT-An scales. Perform tumor imaging evaluation according to RECIST 1.1. Baseline imaging examination should be conducted within 21 days prior to the first administration, and tumor imaging evaluation should be conducted every 6 weeks (± 7 days) since the first study drug administration, or the frequency of imaging evaluation may be increased when there are clinical indications. The imaging examination time should follow calendar days and should not be adjusted due to treatment delay or termination. Subjects who terminate the study drug treatment due to intolerable toxicity or other non disease progression reasons should continue to receive tumor evaluation follow-up until disease progression, withdrawal from the study, or death (whichever occurs earliest) Researchers will monitor potential adverse events (AEs) throughout the entire trial and grade the severity of adverse events according to the guidelines of the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) 5.0. After treatment, the subjects will undergo a 30 day safety follow-up to monitor AE. If the patient does not receive new anti-tumor treatment within 90 days after the last medication, serious adverse events (SAEs) within 90 days after the last medication will be collected. If the subject begins new anti-tumor treatment, SAEs before starting new anti-tumor treatment will be collected, whichever occurs first. This study will be conducted in accordance with Good Clinical Practice for Drugs (GCP).

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2024-04-02
• Primary completion: 2026-01-30
• Completion: 2026-01-31
• First posted: 2024-04-17
• Last updated: 2026-01-28

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study