Clinical trial NCT06370416: the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib
Official title: A Single Arm, Exploratory Clinical Study on the Prevention of Bone Marrow Suppression Caused by Platinum Containing Chemotherapy in Advanced Non-small Cell Lung Cancer With Trilaciclib
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small cell lung cancer（NSCLC）
trilaciclib
Bone marrow protection
chemotherapy
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Jiangsu Simcere Pharmaceutical Co., Ltd.
First posted: 2024-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of tralazili before chemotherapy in patients with NSCLC.After pathological diagnosis of non-small cell lung cancer(NSCLC), 40 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of trilaciclib before chemotherapy, after signing informed consent.

Detailed description: This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of tralazili before chemotherapy in patients with non-small cell lung cancer(NSCLC).After pathological diagnosis of NSCLC, 40 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of trilaciclib before chemotherapy, after signing informed consent.Record the dynamic changes in whole blood cell count; Hematological toxicity, including febrile neutropenia and associated infections; Blood product infusion and supplementation of hematopoietic raw materials; The use of hematopoietic growth factors; Systemic use of antibiotics; Score the EQ-5D-5L, FACT-L, and FACT-An scales. Perform tumor imaging evaluation according to RECIST 1.1. Baseline imaging examination should be conducted within 21 days prior to the first administration, and tumor imaging evaluation should be conducted every 6 weeks (± 7 days) since the first study drug administration, or the frequency of imaging evaluation may be increased when there are clinical indications. The imaging examination time should follow calendar days and should not be adjusted due to treatment delay or termination. Subjects who terminate the study drug treatment due to intolerable toxicity or other non disease progression reasons should continue to receive tumor evaluation follow-up until disease progression, withdrawal from the study, or death (whichever occurs earliest) Researchers will monitor potential adverse events (AEs) throughout the entire trial and grade the severity of adverse events according to the guidelines of the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) 5.0. After treatment, the subjects will undergo a 30 day safety follow-up to monitor AE. If the patient does not receive new anti-tumor treatment within 90 days after the last medication, serious adverse events (SAEs) within 90 days after the last medication will be collected. If the subject begins new anti-tumor treatment, SAEs before starting new anti-tumor treatment will be collected, whichever occurs first.

This study will be conducted in accordance with Good Clinical Practice for Drugs (GCP).

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old, regardless of gender;
* Patients with locally advanced and late stage (IIIB, IIIC, IV) NSCLC who have been confirmed by histopathology and cannot be surgically removed (without local symptoms (with or without brain metastasis)) have at least one measurable lesion that meets the RECIST 1.1 criteria
* Need to receive chemotherapy treatment (first-line chemotherapy treatment uses platinum+pemetrexed/docetaxel/albumin paclitaxel/paclitaxel; second-line chemotherapy treatment: choose the above first-line chemotherapy treatment without using chemotherapy drugs; (Note: If first-line chemotherapy treatment does not combine with immunotherapy, subsequent increase in immunotherapy patients will not be counted as an increase in the number of treatment lines, and the number of treatment lines in this trial is limited to the number of chemotherapy treatment lines)
* The laboratory inspection meets the standards
* ECOG PS score 0-1 points;
* Women: All women with potential fertility must have a negative serum pregnancy test result during the screening period, and reliable contraceptive measures must be taken 3 months after signing the informed consent form and the last dose;
* Understand and sign the informed consent form.

Exclusion Criteria:

* Diagnosed as other malignant diseases other than NSCLC within 5 years prior to initial administration (excluding curative basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curative resection of carcinoma in situ);
* Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA grade III or IV);
* Stroke or cardiovascular events within 6 months prior to enrollment
* When screening, QTcF interval\>480msec, for patients with implanted ventricular pacemakers, QTcF\>500msec
* Previously received hematopoietic stem cell or bone marrow transplantation
* Allergy to the investigational drug or its components;
* The researchers believe that it is not suitable to participate in this study.

Primary outcomes:
measure: The incidence of grade ≥ 3 neutropenia during chemotherapy treatment
timeFrame: 1-2 weeks after chemotherapy
Secondary outcomes:
measure: The incidence of grade 4 neutropenia during chemotherapy treatment
timeFrame: 1-2 weeks after chemotherapy
measure: The incidence of grade 3 or grade 4 thrombocytopenia
timeFrame: 1-2 weeks after chemotherapy
measure: The incidence of grade 3 or 4 anemia during chemotherapy treatment
timeFrame: 1-3 weeks after chemotherapy
Other outcomes:
measure: Objective relief rate
timeFrame: every 6 weeks to 1 year
measure: Disease control rate
timeFrame: every 6 weeks to 1 year
measure: Progression free survival
timeFrame: every 6 weeks to 1 year
measure: Overall survival
timeFrame: every 90 days to 1 year
Locations:
city: Zhengzhou
country: China
facility: Henan Tumor Hospital
state: Henan
Study officials:
References: