the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib

NCT06370416 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: HSKY002
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of tralazili before chemotherapy in patients with NSCLC.After pathological diagnosis of non-small cell lung cancer(NSCLC), 40 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of trilaciclib before chemotherapy, after signing informed consent.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer（NSCLC）; trilaciclib; Bone marrow protection; chemotherapy

Outcome Measures

Primary Outcomes (1)

• The incidence of grade ≥ 3 neutropenia during chemotherapy treatment

  Neutrophils ≤ 1.0\*109

  1-2 weeks after chemotherapy

Secondary Outcomes (3)

• The incidence of grade 4 neutropenia during chemotherapy treatment

  1-2 weeks after chemotherapy

• The incidence of grade 3 or grade 4 thrombocytopenia

  1-2 weeks after chemotherapy

• The incidence of grade 3 or 4 anemia during chemotherapy treatment

  1-3 weeks after chemotherapy

Other Outcomes (4)

• Objective Response Rate

  every 6 weeks to 1 year

• Disease control rate

  every 6 weeks to 1 year

• Progression free survival

  every 6 weeks to 1 year

Study Arms (1)

Trilaciclib group

EXPERIMENTAL

240mg/m2, intravenous infusion for 30 minutes, and administration completed within 4 hours before daily chemotherapy;

Drug: Trilaciclib

Interventions

Trilaciclib DRUG

After pathological diagnosis of NSCLC, 40 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of trilaciclib before chemotherapy, after signing informed consent.

Also known as: Trilaciclib Injection

Trilaciclib group

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 locally advanced and late stage (IIIB, IIIC, IV) NSCLC who have been confirmed by histopathology and cannot be surgically removed (without local symptoms (with or without brain metastasis)) have at least one measurable lesion that meets the RECIST 1.1 criteria
• Need to receive chemotherapy treatment (first-line chemotherapy treatment uses platinum+pemetrexed/docetaxel/albumin paclitaxel/paclitaxel; second-line chemotherapy treatment: choose the above first-line chemotherapy treatment without using chemotherapy drugs; (Note: If first-line chemotherapy treatment does not combine with immunotherapy, subsequent increase in immunotherapy patients will not be counted as an increase in the number of treatment lines, and the number of treatment lines in this trial is limited to the number of chemotherapy treatment lines)
• The laboratory inspection meets the standards
• ECOG PS score 0-1 points;
• Women: All women with potential fertility must have a negative serum pregnancy test result during the screening period, and reliable contraceptive measures must be taken 3 months after signing the informed consent form and the last dose;
• Understand and sign the informed consent form.

You may not qualify if:

• Diagnosed as other malignant diseases other than NSCLC within 5 years prior to initial administration (excluding curative basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curative resection of carcinoma in situ);
• Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA grade III or IV);
• Stroke or cardiovascular events within 6 months prior to enrollment
• When screening, QTcF interval\>480msec, for patients with implanted ventricular pacemakers, QTcF\>500msec
• Previously received hematopoietic stem cell or bone marrow transplantation
• Allergy to the investigational drug or its components;
• The researchers believe that it is not suitable to participate in this study.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: collaborator
• Henan Cancer Hospital: lead

Study Sites (1)

Henan Tumor Hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

trilaciclib

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 17, 2024
• Study Start: April 2, 2024
• Primary Completion: January 30, 2026
• Study Completion: January 31, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)