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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Trilaciclib: 240 mg/m2 as a 30-min iv. infusion, completed ≤4h prior to sacituzumab tirumotecan. Sacituzumab Tirumotecan: 5 mg/kg on days 1 \& 15 of a 28 day cycle via intravenous (IV) infusion until progressive disease or discontinuation.
Incidence of grade ≥ 3 neutropenia during sacituzumab tirumotecan treatment
Time frame: Time from date of first dose of trilaciclib and sacituzumab tirumotecan through 30 days following the last dose of trilaciclib and sacituzumab tirumotecan
Incidence rate of grade 3 or 4 thrombocytopenia
Time frame: Time from date of first dose of trilaciclib and sacituzumab tirumotecan 30 days following the last dose of trilaciclib and sacituzumab tirumotecan
Incidence rate of grade 3 or 4 anemia during sacituzumab tirumotecan treatment
Time frame: Time from date of first dose of trilaciclib and sacituzumab tirumotecan through 30 days following the last dose of trilaciclib and sacituzumab tirumotecan
Incidence rate of febrile neutropenia
Time frame: Time from date of first dose of trilaciclib and sacituzumab tirumotecan through 30 days following the last dose of trilaciclib and sacituzumab tirumotecan
Usage rate of symptomatic treatments for myelosuppression
Such as granulocyte colony-stimulating factor (G-CSF) (not for prevention), thrombopoietin (TPO), interleukin-11 (IL-11), erythropoiesis-stimulating agents (ESA), iron supplements, etc
Time frame: Time from date of first dose of trilaciclib and sacituzumab tirumotecan through 30 days following the last dose of trilaciclib and sacituzumab tirumotecan
Objective response rate (ORR)
Time frame: 18 months after the last subject participating in
Disease control rate (DCR)
Time frame: 18 months after the last subject participating in
Duration of response (DOR)
Time frame: 18 months after the last subject participating in
Progression-free survival (PFS)
Time frame: 18 months after the last subject participating in
Overall survival (OS)
Time frame: From the date of randomization to the date of death for patients who died in the study due to any cause, or to the last contact date known to be alive for those who survived as of the data cutoff date, assessed up to 30 months.
Incidence rate of adverse events
Time frame: Time from date of first dose of trilaciclib and sacituzumab tirumotecan through 90 days following the last dose of trilaciclib and sacituzumab tirumotecan
Evaluate the relationship between standardized uptake value (SUV) of target lesion at baseline and treatment efficacy of Sacituzumab Tirumotecan.
The changes (%) in lesion SUV values before and after treatment with Sacituzumab Tirumotecan.
Time frame: 18 months after the last subject participating in
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