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Phase II Clinical Trial of Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This study is a prospective, single arm phase II study aimed at patients with locally advanced or metastatic non-small cell lung cancer undergoing second-line or beyond treatment. The aim is to evaluate the bone marrow protective effect of trilaciclib before docetaxel chemotherapy for locally advanced or metastatic NSCLC.
After obtaining informed consent from patients diagnosed with locally advanced or metastatic NSCLC through pathology, 33 eligible subjects who met the inclusion criteria were selected to receive the treatment regimen of trilaciclib before docetaxel chemotherapy, with a treatment period of 4 cycles. Record the dynamic changes of whole blood cell count; Hematological toxicity, including febrile neutropenia and associated infections; Transfusion of blood products and supplementation of hematopoietic raw materials. Perform tumor imaging evaluation according to RECIST 1.1. Baseline imaging examination shall be conducted within 21 days prior to the first administration, and tumor imaging evaluation shall be conducted every 6 weeks (± 7 days) from 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 the calendar day 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)
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Start Date
May 9, 2025
Primary Completion Date
May 1, 2026
Completion Date
June 1, 2026
Last Updated
June 8, 2025
33
ESTIMATED participants
Trilaciclib combined with Docetaxel
DRUG
Lead Sponsor
The First Affiliated Hospital of Xiamen University
NCT07190248
NCT06305754
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07100080