Actively Recruiting
Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC)
Led by The First Affiliated Hospital of Xiamen University · Updated on 2026-04-14
49
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, single arm phase II clinical trial aimed at patients with advanced non-small cell lung cancer resistant to EGFR-TKI. The aim is to evaluate the efficacy and safety of trilaciclib in bone marrow protection before monotherapy with sacituzumab tirumotecan. Patients with advanced non-small cell lung cancer resistant to EGFR-TKI, after signing informed consent, will be screened for eligible subjects who meet the inclusion criteria. Prior to receiving treatment with sacituzumab tirumotecan, they will be treated with trilaciclib until disease progression or intolerable toxicity occurs. Record the dynamic changes of whole blood cell count; Hematological toxicity, including febrile neutropenia and associated infections; Transfusion of blood products and supplementation of hematopoietic raw materials. 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 shall be conducted every 6 weeks (± 7 days) from the first study drug administration, or the frequency of imaging evaluation may be increased when there are clinical indications. Subjects who terminate the study drug treatment due to intolerable toxicity or other non disease progression reasons continue to receive tumor evaluation follow-up until disease progression, withdrawal from the study, or death (whichever occurs earliest). After the screening period and one cycle of treatment, subjects may choose to undergo whole-body PET/CT imaging for exploratory analysis.
CONDITIONS
Official Title
Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- ECOG performance status score of 0 or 1
- Expected survival time of at least 3 months
- Diagnosed with locally advanced or metastatic EGFR mutant non-small cell lung cancer confirmed by histology or cytology
- Have failed third-generation EGFR-TKI treatment after up to second-line EGFR-TKI treatment failure
- Patients progressed on 1-2 generations of EGFR-TKI must receive third-generation EGFR-TKI treatment
- Patients progressing more than 6 months after last third-generation EGFR-TKI in neoadjuvant or adjuvant therapy must receive third-generation EGFR-TKI again before study
- Patients progressing within 6 months after last third-generation EGFR-TKI in neoadjuvant or adjuvant therapy can participate directly
- Imaging-confirmed disease progression during or after recent first-line treatment
- At least one measurable lesion per RECIST 1.1 criteria
- Adequate organ function with blood counts and biochemical tests within specified limits without recent transfusions or growth factor corrections
- Recovery from previous treatment toxicities to grade 1 or less (except hair loss)
- Negative pregnancy test for women of childbearing potential and use of reliable contraception until 3 months after last dose
- Voluntary participation with informed consent signed
You will not qualify if you...
- History of myeloid leukemia, myelodysplastic syndrome, or sickle cell disease
- Symptomatic central nervous system metastases or leptomeningeal disease needing immediate radiotherapy or steroids
- Surgery or radiotherapy within 4 weeks before first study drug dose
- Uncontrolled heart conditions including NYHA grade 2 or above heart failure, unstable angina, recent myocardial infarction within 6 months, or significant arrhythmias needing treatment
- History of interstitial lung disease, progressive dyspnea with dry cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary allergic pneumonia, or multiple allergic or peripheral arterial diseases
- Previous hematopoietic stem cell or bone marrow transplantation
- Concurrent need for radiation therapy
- Known allergy to study drug components
- Pregnant or breastfeeding women
- Any other condition deemed unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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