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Trial Title:
A Study of Trilaciclib Combined With Chemotherapy in the Treatment of NSCLC
NCT ID:
NCT06328049
Condition:
NSCLC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Trilaciclib Injection
Description:
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.
Arm group label:
Trilaciclib plus chemotherapy
Other name:
CDK4/6 inhibitors
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Taixing People's Hospital
Address:
City:
Taixing
Zip:
225400
Country:
China
Status:
Recruiting
Contact:
Last name:
liu C yang, M.D.
Phone:
87656001
Phone ext:
0523
Email:
liuyctx@163.com
Start date:
August 10, 2023
Completion date:
August 10, 2025
Lead sponsor:
Agency:
Taixing People's Hospital
Agency class:
Other
Source:
Taixing People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06328049
