Actively Recruiting
Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-06-08
33
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Diagnosed with stage IV non-small cell lung cancer (NSCLC) after failure of at least one standard treatment
- Patients with negative driver genes must have received first-line chemotherapy combined with immunotherapy
- Patients with positive driver genes must have received at least one line of chemotherapy after targeted therapy failure
- At least one measurable tumor lesion according to RECIST 1.1 criteria
- Laboratory results meeting specified blood counts, kidney and liver function thresholds
- Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 2
- Expected survival time of 3 months or longer
- Women of childbearing potential must have a negative pregnancy test and use reliable contraception from consent until 3 months after last dose
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior treatment with docetaxel
- Diagnosis of malignant diseases other than NSCLC within 5 years (excluding certain skin cancers)
- Uncontrolled ischemic heart disease or significant congestive heart failure (NYHA class III or IV)
- Stroke or cardiovascular events within 6 months before enrollment
- QTcF interval greater than 480 milliseconds or greater than 500 milliseconds in patients with ventricular pacemakers
- HIV infection or known syphilis infection
- Previous hematopoietic stem cell or bone marrow transplantation
- Allergies to study drugs or their components
- Investigator judgment deeming participant unsuitable for the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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