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Clinical Trials in China / NCT06929936
Recruiting Phase 2

Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC

NCT06929936 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital of Xiamen University
Phase
Phase 2
Started
2025-05-09
Last updated
2025-06-08

Condition(s) studied

Non-Small Cell Lung CancerMyelosuppression

Investigational drug(s) / intervention(s)

Trilaciclib combined with Docetaxel

Trilaciclib combined with Docetaxel: Trilaciclib: 240 mg/m2 as a 30-min iv. infusion, completed ≤4h prior to chemotherapy. Docetaxel: 75mg/m2, iv. infusion for 1 hour on days 1 of each 21-day cycle, totaling 4 cycles of medication.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be included in this study: 1. Age ≥ 18 years old, regardless of gender; 2. Patients with stage IV NSCLC who have failed at least one line of standard treatment regimen: A. Patients with negative driver genes must have received first line standard treatment (chemotherapy combined with immunotherapy). B. Patients with positive driver genes must have received at least one line chemotherapy after standard targeted therapy has failed. C. Definition of driver genes: EGFR (including 19del, L858R, S768I, L861Q, and/or G719X), BRAF V600E, NTRK, MET14 exon skipping mutation, RET, ROS1, etc. 3. At least one measurable lesion that meets the RECIST 1.1 criteria exists; 4. The laboratory test results meet the following criteria: Hemoglobin ≥ 100 g/L (female), 110g/L (male) ,Neutrophil count ≥ 2×109/L Platelet count ≥ 100×109/L; Creatinine ≤15mg/L or creatinine clearance rate (CrCl) ≥ 60mL/min (Cockcroft Gault formula); Total bilirubin ≤ 1.5xupper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN or ≤ 5×ULN (for patients with liver metastases); Albumin ≥ 30 g/L; 5. ECOG PS score 0-2; 6. Expected survival time ≥ 3 months; 7. Women: All women with potential fertility must have a negative serum pregnancy test result during the screening period, and must take reliable contraceptive measures from signing the informed consent form until 3 months after the last dose; 8. Understand and sign the informed consent form. Exclusion Criteria: 1. Previously received treatment with docetaxel; 2. Diagnosed with malignant diseases other than NSCLC within 5 years prior to the first administration (excluding curative basal cell carcinoma, squamous cell carcinoma, and/or excised carcinoma in situ); 3. Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV); 4. Stroke or cardiovascular events within the first 6 months of enrollment; 5. When screening, if the QTcF interval is greater than 480 milliseconds, for patients implanted with ventricular pacemakers, QTcF\>500msec; 6. Human immunodeficiency virus (HIV) infected individuals (HIV 1/2 antibody positive), known syphilis infected individuals; 7. Previously received hematopoietic stem cell or bone marrow transplantation; 8. Allergies to research drugs or their components; 9. The researchers believe that it is not suitable to participate in this study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Xiamen University Xiamen Fujian Recruiting

More The First Affiliated Hospital of Xiamen University trials in China

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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 NCT06929936 on ClinicalTrials.gov ↗ ← All trials in China