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

NCT06328049 | Recruiting Phase 2

• 1 other identifier: HSKY-033
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Incidence of febrile neutropenia (FN)

  Incidence of febrile neutropenia in the first treatment cycle

  during Trilaciclib plus chemotherapy assessed up to 21 days

Secondary Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events

  Up to 2 years

• Antibiotic Use rate

  during Trilaciclib plus chemotherapy assessed up to 21 days

• Number of medication delays

  At the end of Cycle 1 (each cycle is 28 days)

• Number of chemotherapy dose reductions

  At the end of Cycle 1 (each cycle is 28 days)

Study Arms (1)

Trilaciclib plus chemotherapy

EXPERIMENTAL

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.

Drug: Trilaciclib Injection

Interventions

Trilaciclib Injection 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.

Also known as: CDK4/6 inhibitors

Trilaciclib plus chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taixing People's Hospital: lead

Study Sites (1)

Taixing People's Hospital

Taishing, Jiangsu, 225400, China

RECRUITING

MeSH Terms

Interventions

trilaciclib

Study Officials

• liu C yang, M.D.

  Taixing People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

liu C yang, M.D.

CONTACT

87656001; liuyctx@163.com

Study Design

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

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 25, 2024
• Study Start: August 10, 2023
• Primary Completion: February 10, 2025
• Study Completion: August 10, 2025
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

CN (1)