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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06328049
Other study ID # HSKY-033
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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