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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Patients must meet all of the following inclusion criteria to be included in this study:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Time Frame
Start Date: 2025-05-09
Estimated Completion Date: 2026-06
Participants
Target number of participants: 33
Treatments
Experimental: Trilaciclib combined with Docetaxel
Trilaciclib combined with Docetaxel
Sponsors
Leads: The First Affiliated Hospital of Xiamen University

This content was sourced from clinicaltrials.gov

Similar Clinical Trials