This study is a multicenter, single-arm, phase II clincial trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (sac-TMT) and Furmonertinib in the treatment of EGFR-mutant advanced or metastatic NSCLC after failure of first-line Third-generation EGFR-TKI therapy.
Monotherapy with third-generation EGFR-TKIs has become the standard first-line treatment for advanced NSCLC with EGFR mutations. However, acquired resistance inevitably occurs. ADCs harness the precise targeting and selectivity of monoclonal antibodies while capitalizing on the potent cytotoxic effects of their payload, thereby minimizing off-target toxicity. Sacituzumab Tirumotecan (sac-TMT) is a novel TROP2-directed ADC, had shown encouraging antitumor efficacy in previously treated patients with EGFR mutated advanced NSCLC. Theoretically, combination with small molecule inhibitors (including EGFR-TKI) are one of the combinational strategies for TROP2-ADC with synergistic mechanism. This study aims to evaluate the efficacy and safety of furmonertinib plus Sacituzumab Tirumotecan in patients with EGFR mutated advanced NSCLC after failure of first-line third-generation EGFR-TKI therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
fixed dosage 4mg/kg iv, D1, D15, each 4 weeks one cycle. Drug reduction will be implemented according to the research plan.
160mg QD or 80mg QD, each 4 weeks one cycle, according to the safety run-in phase, until confirmed by the investigator as imaging disease progression, intolerable toxicity, subject's request to terrminate treatment, or other treatment termination criteria specified in the protocol. Drug reduction will be implemented according to the research plan.
Objective Response Rate (ORR)
Objective Response Rate (ORR) assessed according to the evaluation criteria for the efficacy of RECIST v1.1
Time frame: Up to approximately 12 months
Progression Free Survival (PFS)
The time from the beginning of the patient's treatment to the disease progression or death for any reason. Based on RECIST v1.1.
Time frame: From treatment administration up to a maximum duration of 12 months.
Duration of Response (DoR)
The time from the first time the evaluation results meet CR or PR criteria to the observation of PD or death.
Time frame: Through study completion, an expected average of 12 months.
Disease Control Rate (DCR)
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD) in total subjects after the last subject participating in.
Time frame: From treatment administration up to a maximum duration of 12 months.
Overall Survival (OS)
Time from start of treatment to death due to any cause.
Time frame: From treatment administration up to a maximum duration of 12 months.
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