Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC
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
The First Affiliated Hospital of Xiamen University
33 participants
May 9, 2025
INTERVENTIONAL
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
Inclusion Criteria12
- Age ≥ 18 years old, regardless of gender;
- 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.
- At least one measurable lesion that meets the RECIST 1.1 criteria exists;
- 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;
- ECOG PS score 0-2;
- Expected survival time ≥ 3 months;
- 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;
- Understand and sign the informed consent form.
Exclusion Criteria9
- Previously received treatment with docetaxel;
- 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);
- Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV);
- Stroke or cardiovascular events within the first 6 months of enrollment;
- When screening, if the QTcF interval is greater than 480 milliseconds, for patients implanted with ventricular pacemakers, QTcF\>500msec；
- Human immunodeficiency virus (HIV) infected individuals (HIV 1/2 antibody positive), known syphilis infected individuals;
- Previously received hematopoietic stem cell or bone marrow transplantation;
- Allergies to research drugs or their components;
- The researchers believe that it is not suitable to participate in this study.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06929936