A Phase Ⅱ Study of RC108 in Combination With Furmonertinib for the First-line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC

Exclusion Criteria

• •1. Subjects with the presence of meningeal metastases, spinal cord compression, or active brain metastases；
• •2. Received ADC or MET inhibitors；
• •3. Suffering from refractory nausea and vomiting, chronic gastrointestinal disorders, inability to swallow pharmaceutical preparations, or previous major bowel resection that may prevent adequate absorption, distribution, metabolism, or excretion of oral medications;
• •4. Subjects with uncontrolled tumor-related pain；
• •5. Use of an investigational drug or major surgery within 4 weeks before the first dose;
• •6. Received any live vaccine within 28 days prior to the first dose or plan to be vaccinated during the study;
• •7. Subjects with uncontrolled or severe cardiovascular disease;
• •8. Presence of clinically uncontrollable third interstitial effusion;
• •9. Presence of severe lung disease, including but not limited to active tuberculosis, interstitial lung disease requiring treatment, radiation pneumonitis, etc.
• •10. Toxicity due to prior antineoplastic therapy has not recovered to National Cancer Institute Commonly Used Criteria Terminology for Generic Adverse Events, Version 5.0, Grade 0-1;
• •11. Persistent grade ≥2 sensory or motor neuropathy;
• •12. Active infections requiring systemic IV antibiotic therapy within 7 days before the first dose, allowing routine antimicrobial prophylaxis;
• •13. Positive test result for Human Immunodeficiency Virus (HIV) or history of Acquired Immune Deficiency Syndrome (AIDS);
• •14. Active hepatitis B or HCV-positive subjects;
• •15. Received systemic corticosteroid therapy with \>10 mg/day prednisone or other immunosuppressive medications within 2 weeks before randomization;
• •16. Other malignant tumor within 5 years before signed the informed consent form;
• •17. Known hypersensitivity or delayed hypersensitivity to RC108, certain components of Furmonertinib or similar drugs or any contraindication to the drug;
• •18. Poor compliance and unable to complete the study procedures as assessed by investigator;