A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer

Exclusion Criteria

• •History of hypersensitivity to any component of the investigational product.
• •No documented progression after prior treatment, or recurrence during or after prior treatment.
• •Received radiotherapy, chemotherapy, biologicals, immunotherapy or other anti-tumor drugs within 4 weeks prior to the first dose of study treatment.
• •Presence of central nervous system metastasis.
• •Patients with significant clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage prior to the first dose of study drug.
• •Any severe or uncontrolled systemic disease judged by the investigator.
• •Patients with poorly controlled heart diseases.
• •Evidence of active infections, including Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) infection.
• •Active bacterial, viral, fungal, rickettsial, or parasitic infection requiring systemic therapy.
• •Prior history of other primary malignancies.
• •History of the following ophthalmologic abnormalities: severve dry eye syndrome; keratoconjunctivitis sicca; severe exposure keratitis; any other condition that may increase the risk of corneal epithelial damage.
• •History of severe skin disease requiring interruption of previous EGFR targeted therapy; or chronic skin disease requiring oral or intravenous therapy.
• •History of interstitial lung disease (ILD) or pneumonitis, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
• •Pulmonary radiotherapy \> 30 Gy within 6 months prior to first dose of study drug.
• •Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.
• •Patients with active autoimmune disease or history of autoimmune disease, who are using immunosuppressive agents or systemic hormone therapy and still receiving within 2 weeks prior to enrollment.
• •History of allogeneic tissue or solid organ transplant.
• •Female patients with a positive serum pregnancy test or who are breast feeding or do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment.
• •Active uncontrolled concomitant diseases that might limit patient's compliance with study requirements, or compromise patient's ability to provide written informed consent.
• •Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.