This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection combined with pyrotinib in subjects with local advanced or metastatic non-small cell lung cancer with HER2 mutation.
Voluntary agreement to provide written informed consent.
Predicted survival ≥ 12 weeks.
According to UICC/AJCC 8th Edition, histologically and/or cytologically-confirmed, cannot be surgically removed, locally advanced or metastatic NSCLC.
Is willing and able to provide an adequate archival tumor tissue sample
No known EGFR, ALK, ROS1, RET, NTRK, MET 14 or BRAF V600E mutation.
Patient has had previous treatment with HER2-targeted therapy prior to study participation.
History of major surgery within 4 weeks of planned start of trial treatment.
Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive.
Single group
RC48-ADC
DrugRC48-ADC 1.5/2.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 14-day cycle
Pyrotinib
DrugPyrotinib 400 mg by oral once a day.
maximal tolerance dose (MTD) of RC48-ADC combined with Pyrotinib
Maximum-tolerated dose (MTD) was defined as the highest dose level at which no more than one of six patients experienced DLT during the DLT assessment window.
Overall response rate (ORR)
The objective response rate will be mainly analyzed by investigators according to the RECIST 1.1 standard tumor evaluation.
Disease control rate (DCR)
Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.
Duration of relief (DOR)
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.
Progression-free survival (PFS)
Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death.
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