Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advance… (NCT06929936) | Clinical Trial Compass
RecruitingPhase 2
Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC
China33 participantsStarted 2025-05-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years old, regardless of gender;
✓. Patients with stage IV NSCLC who have failed at least one line of standard treatment regimen:
✓. At least one measurable lesion that meets the RECIST 1.1 criteria exists;
✓. The laboratory test results meet the following criteria:
✓. 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 criteria
✕. 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;
What they're measuring
1
Incidence of grade ≥ 3 neutropenia during chemotherapy treatment
Timeframe: Time from date of first dose of trilaciclib and docetaxel through 30 days following the last dose of trilaciclib and docetaxel
Trial details
NCT IDNCT06929936
SponsorThe First Affiliated Hospital of Xiamen University