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

NCT ID: NCT06328049

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2025-08-10

Brief 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.

Detailed 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.

Conditions

NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Trilaciclib plus chemotherapy

Patients with lung adenocarcinoma were treated with Trilaciclib (240mg/m2, d1, within 4 hours before each chemotherapy) combined with pemetrexed and carboplatin (dose according to the guideline recommendation, d1, Q3W). "For squamous lung cancer, Trilaciclib (d1, 240mg/m2, 4 hours before each chemotherapy) plus paclitaxel/albumin-bound paclitaxel plus carboplatin (dose according to guideline recommendation, d1), Q3W." In the second cycle, patients were left to their own discretion with or without treaclib combination therapy.

Group Type: EXPERIMENTAL

Trilaciclib Injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

CDK4/6 inhibitors

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taixing People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liu Yangchen

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

liu C yang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Taixing People's Hospital

Locations

Taixing People's Hospital

Taishing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

liu C yang, M.D.

Role: CONTACT

liuyctx@163.com

87656001 ext. 0523

Facility Contacts

liu C yang, M.D.

Role: primary

liuyctx@163.com

87656001 ext. 0523

Other Identifiers

HSKY-033

Identifier Type: -

Identifier Source: org_study_id