Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC (PROTECT-1)

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 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.

Study Overview

• Status: Recruiting
• Conditions: Non-Small Cell Lung Cancer; Myelosuppression
• Intervention / Treatment: Drug: Trilaciclib combined with Docetaxel

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 treatment regimen of trilaciclib before docetaxel chemotherapy, with a treatment period of 4 cycles.

Record the dynamic changes of whole blood cell count; Hematological toxicity, including febrile neutropenia and associated infections; Transfusion of blood products and supplementation of hematopoietic raw materials. Perform tumor imaging evaluation according to RECIST 1.1. Baseline imaging examination shall be conducted within 21 days prior to the first administration, and tumor imaging evaluation shall be conducted every 6 weeks (± 7 days) from the first study drug administration, or the frequency of imaging evaluation may be increased when there are clinical indications. The imaging examination time should follow the calendar day and should not be adjusted due to treatment delay or termination. Subjects who terminate the study drug treatment due to intolerable toxicity or other non disease progression reasons should continue to receive tumor evaluation follow-up until disease progression, withdrawal from the study, or death (whichever occurs earliest)

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China
      • Recruiting
      • The first affiliated hospital of xiamen university
      • Contact: Wu; Phone Number: 86 592 2137611; Email: 23889925@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trilaciclib combined with Docetaxel	Drug: Trilaciclib combined with Docetaxel; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	such as granulocyte colony-stimulating factor (G-CSF) (not for prevention), thrombopoietin (TPO), interleukin-11 (IL-11), erythropoiesis-stimulating agents (ESA), iron supplements, etc	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
Disease control rate		12 months after the last subject participating in
Duration of response		12 months after the last subject participating in
Progression-free survival		12 months after the last subject participating in
Overall survival		From the date of randomization to the date of death for patients who died in the study due to any cause, or to the last contact date known to be alive for those who survived as of the data cutoff date, assessed up to 30 months.
Incidence rate of adverse events		Time from date of first dose of trilaciclib and docetaxel through 90 days following the last dose of trilaciclib and docetaxel

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 23, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: PROTECT-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No