A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer

Exclusion Criteria

• •1. Have used T-DM1 or participated in other HER2-ADC clinical studies.
• •2. Received anti-tumor treatment 4 weeks before study administration, including chemotherapy (late toxicity chemotherapy was 6 weeks before study administration), radiotherapy (palliative local radiotherapy for bone metastases was 2 weeks before the study administration), biological therapy (small molecule targeted drugs were 8 days before the study administration) or immunotherapy, etc.
• •3. Major surgery was performed within 4 weeks prior to study administration and did not fully recover.
• •4. Other clinical trial drugs have been used within 4 weeks before the start of study administration.
• •5. Live vaccine received within 4 weeks before the start of study administration.
• •6. Have received anti-tumor Chinese medicine treatment within 2 weeks before the start of study administration.
• •7. History of other malignant tumors within 5 years before signing the informed consent (except for non-melanoma skin cancer, cervical carcinoma in situ that has been effectively treated, or malignant tumors that have been resolved for more than 3 years after effective treatment and are considered to be cured) .
• •8. Toxicity of previous anti-tumor treatment has not recovered to CTCAE (version 4.03) 0-1, except for the following conditions: a. Hair loss; b. Pigmentation; c. Long-term toxicity caused by radiotherapy, which cannot be restored by the judgement of the investigator.
• •9. Active central nervous system (CNS) metastasis and/or cancerous meningitis (subjects who have received brain metastasis treatment can participate in this study, provided that the condition is stable (no evidence of progression confirmed by imaging studies at least 4 weeks before study dosing, and all neurological symptoms have returned to baseline levels), no evidence of new or enlarged brain metastases, and discontinuation of steroid treatment at least 7 days before the first dose of trial treatment. This exception does not include cancerous meningitis, which should be excluded whether clinical status was stable).
• •10. Diagnosed with HBsAg positive and HBV DNA positive, or HCV Ab positive, or HIV Ab positive.
• •11. Severe arterial/venous thrombosis or cardio-cerebral vascular accidents occurred within 1 year before the study, such as deep vein thrombosis, pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, etc.
• •12. Active infections requiring systemic treatment.
• •13. Other lung diseases required systemic treatment such as active tuberculosis, interstitial lung disease, etc.
• •14. Uncontrolled systemic diseases such as diabetes, hypertension, cirrhosis, etc.
• •15. Heart failure graded 3 or above by the NYHA.
• •16. Pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms that cannot be controlled by drainage or other methods.
• •17. Mental illness or substance abuse known to have an impact on compliance with study requirements.
• •18. Hypersensitivity or delayed allergic reaction to certain components of RC48-ADC or similar drugs.
• •19. Any other disease, metabolic abnormality, abnormal physical examination or abnormal laboratory test, etc., based on the judgment of the investigator, it is reasonable to suspect that the patient has a certain disease or condition unsuitable for the research drug, or will affect the interpretation of the research results, or putting patients at high risk.
• •20. Pregnant or lactating female or female / male who are planning to have children.
• •21. Insufficient adherence to participate in this clinical study.
• •22. Any other condition in which the investigator considers the patient unsuitable for this study.