A Study of Trilaciclib Combined With Chemotherapy in the Treatment of NSCLC

NSCLC Clinical Trial

Official title:

A Prospective, Single-arm, Exploratory Clinical Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06328049
• Other study ID #: HSKY-033
• Status: Recruiting
• Phase: Phase 2
• Start date: August 10, 2023
• Est. completion date: August 10, 2025

Study information

• Verified date: March 2024
• Source: Taixing People's Hospital
• Contact: liu C yang, M.D.
• Phone: 87656001
• Email: liuyctx[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the safety and efficacy of the prophylactic use of Trilaciclib in patients with non-small cell lung cancer (NSCLC) receiving platinum-based chemotherapy, so as to provide more evidence-based medical evidence for the optimal diagnosis and treatment strategy in this population.

Description:

This is a single-arm, exploratory clinical study. Eligible patients were treated with Trilaciclib before the first cycle of chemotherapy, and their peripheral blood samples were tested on days 3,7,14,21±1 after chemotherapy. At the same time, the incidence of FN, the use of antibiotics, the safety, the number of patients who delayed the second cycle of treatment, the number of patients who reduced the dose of chemotherapy, the number of patients who reduced the dose of chemotherapy due to neutropenia, and the number of patients who discontinued chemotherapy were observed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 10, 2025
• Est. primary completion date: February 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age above 18 years old (including 18 years old),regardless of gender;
• ECOG-PS score of 0-1,;
• expected survival=12 weeks;
• There was no tumor deterioration in the 2 weeks prior to study drug treatment.
• Advanced non-small cell lung cancer without systemic chemotherapy.
• At least one tumor lesion with a maximum diameter =10 mm (short diameter =15 mm if it is a lymph node) that could be measured accurately at baseline according to RECIST1.1 criteria. Baseline tumor imaging was performed within 28 days before the first dose.
• Women of childbearing age should use appropriate contraception and should not breastfeed from screening until 3 months after discontinuation of study treatment.
• Male subjects should use barrier contraception (i.e., condoms) for 3 months from screening until discontinuation of study treatment.
• All subjects voluntarily participated and signed the informed consent form in person.

Exclusion Criteria:

• Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV);
• stroke or cardio-cerebrovascular event within 6 months before enrollment;
• QTcF interval > 480msec at screening or > 500msec for patients with implanted ventricular pacemakers;
• Previous hematopoietic stem cell or bone marrow transplantation;
• Allergy to the study drug or its components;
• Others considered by the investigator to be unsuitable for this study.

Related Conditions & MeSH terms

• NSCLC

Intervention

Drug:
• Trilaciclib Injection
Patients with lung adenocarcinoma were given Trilaciclib combined with pemetrexed and carboplatin, Q3W; For patients with lung squamous cell carcinoma,Trilaciclib combined with paclitaxel/albumin-bound paclitaxel and carboplatin, Q3W. From cycle 2 onwards, patients chose whether to use trasylol with chemotherapy.

Locations

Country	Name	City	State
China	Taixing People's Hospital	Taixing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Taixing People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of febrile neutropenia (FN)	Incidence of febrile neutropenia in the first treatment cycle	during Trilaciclib plus chemotherapy assessed up to 21 days
Secondary	Incidence of Treatment-Emergent Adverse Events	Occurrence and severity of AEs by NCI CTCAE v5.0	Up to 2 years
Secondary	Antibiotic Use rate	Antibiotic Use rate in the first treatment cycle	during Trilaciclib plus chemotherapy assessed up to 21 days
Secondary	Number of medication delays	Number of delays in the second treatment cycle due to myelosuppression	At the end of Cycle 1 (each cycle is 28 days)
Secondary	Number of chemotherapy dose reductions	Number of chemotherapy dose reductions in the second treatment cycle due to myelosuppression	At the end of Cycle 1 (each cycle is 28 days)