Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC

NCT06929936 | Recruiting Phase 2

• 1 other identifier: PROTECT-1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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 evaluate the bone marrow protective effect of trilaciclib before docetaxel chemotherapy for locally advanced or metastatic NSCLC.

Conditions

Non-Small Cell Lung Cancer; Myelosuppression

Outcome Measures

Primary Outcomes (1)

• Incidence of grade ≥ 3 neutropenia during chemotherapy treatment

  Time from date of first dose of trilaciclib and docetaxel through 30 days following the last dose of trilaciclib and docetaxel

Secondary Outcomes (10)

• Incidence rate of grade 3 or 4 thrombocytopenia

  Time from date of first dose of trilaciclib and docetaxel through 30 days following the last dose of trilaciclib and docetaxel

• Incidence rate of grade 3 or 4 anemia during chemotherapy treatment

  Time from date of first dose of trilaciclib and docetaxel through 30 days following the last dose of trilaciclib and docetaxel

• Incidence rate of febrile neutropenia

  Time from date of first dose of trilaciclib and docetaxel through 30 days following the last dose of trilaciclib and docetaxel

• Usage rate of symptomatic treatments for myelosuppression

  Time from date of first dose of trilaciclib and docetaxel through 30 days following the last dose of trilaciclib and docetaxel

• Objective response rate

  12 months after the last subject participating in

Study Arms (1)

Trilaciclib combined with Docetaxel

EXPERIMENTAL

Trilaciclib combined with Docetaxel

Drug: Trilaciclib combined with Docetaxel

Interventions

Trilaciclib combined with Docetaxel DRUG

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.

Trilaciclib combined with Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: April 16, 2025
• Study Start: May 9, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)