Status:
RECRUITING
Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Conditions:
Non-Small Cell Lung Cancer
Myelosuppression
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 evalua...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06929936
Start Date
May 9 2025
End Date
June 1 2026
Last Update
June 8 2025
Active Locations (1)
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1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China