Trilaciclib plus docetaxel for second-line or later advanced non-small cell lung cancer

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

This test gives trilaciclib before docetaxel to see if it protects bone marrow and reduces low blood counts in people with advanced or metastatic non-small cell lung cancer receiving second-line or later chemotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Xiamen University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Xiamen, Fujian)
• Trial ID: NCT06929936 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm phase II trial enrolling 33 patients with locally advanced or metastatic NSCLC who have progressed after at least one prior systemic regimen. Participants receive trilaciclib prior to docetaxel for up to four treatment cycles, with serial monitoring of whole blood counts and hematologic adverse events. The study tracks febrile neutropenia, infections, blood product transfusions, and need for hematopoietic support, and performs tumor assessments by RECIST 1.1 every six weeks. Patients who stop study drug for toxicity continue imaging follow-up until progression, withdrawal, or death.

Who should consider this trial

Good fit: Adults (≥18) with stage IV NSCLC who have progressed after at least one prior standard regimen (chemotherapy plus immunotherapy for driver‑negative disease or chemotherapy after failed targeted therapy for driver‑positive disease), with at least one measurable lesion and adequate blood counts and organ function are the intended participants.

Not a fit: Patients with disease controlled by ongoing targeted therapy, those with inadequate baseline blood counts or organ dysfunction, or those who cannot receive docetaxel are unlikely to benefit from this regimen.

Why it matters

Potential benefit: If successful, patients may experience fewer chemotherapy-related low blood counts, infections, transfusions, and treatment delays.

How similar studies have performed: Trilaciclib has demonstrated bone marrow protective effects in prior trials, particularly in small‑cell lung cancer, but randomized and robust evidence in NSCLC is limited.

Eligibility criteria

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.

Where this trial is running

Xiamen, Fujian

• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)

Conditions Non-Small Cell Lung Cancer; Myelosuppression