A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation

Inclusion Criteria

• •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
• •Has relapsed from or is refractory to standard treatment and had received both platinum-based therapy and immunotherapy.
• •Measurable lesion according to RECIST 1.1.
• •Documented HER2 exon 20 insertion mutation.
• •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• •Adequate organ function.
• •For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive (such as an intrauterine device, contraceptives, or condoms) during study treatment and within 6 months after the end of study, the blood pregnancy test within 7 days of study enrollment must be negative and must be non-lactating. Male subjects: Patients who should be surgically sterilized or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study.
• •Willing and able to follow trial and follow-up procedures.