JMT101 Combined With Osimertinib in Patients With Stage Ⅲb-Ⅳ Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Common Mutations

Exclusion Criteria

• •1. Previously received EGFR monoclonal antibody therapy.
• •2. Have received anti-tumor treatments such as chemotherapy, biological therapy, targeted therapy, immunotherapy, etc. within 4 weeks prior to the first use of the study drug.
• •3. Have undergone major organ surgery (excluding biopsy) or experienced significant trauma within 4 weeks prior to the first use of the study drug.
• •4. Have received other clinical study drugs within 4 weeks prior to the first use of the study drug.
• •5. Known hypersensitivity or intolerance to any component of the study drug or its excipients.
• •6. Those who use strong or moderate CYP3A4 inducers within 14 days before the first administration of the study drug.
• •7. The adverse reactions of previous anti-tumor treatments have not yet recovered to CTCAE 5.0 evaluation ≤ level 1 except for toxicity such as alocepia, which is judged to be of no safety risk by researchers;
• •8. Central nervous system metastasis or meningeal metastasis with clinical symptoms.
• •9. Having a history of autoimmune diseases, immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.
• •10. Active hepatitis B (hepatitis B virus titer\>1000 copies/mL or 200 IU/mL); Hepatitis C virus and syphilis infections.
• •11. Have a history of serious cardiovascular disease.
• •12. Unable to swallow medication orally, or has a condition that has been determined by researchers to seriously affect gastrointestinal absorption.
• •13. Within 5 years prior to the first use of the study drug, there were other malignant tumors, except for localized tumors such as cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ that have been confirmed to be cured.
• •14. Any evidence of a history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid treatment, or clinically active interstitial lung disease.
• •15. Patients with a history of other serious systemic diseases who have been determined by the researchers to be unsuitable for clinical trials.
• •16. Known to have alcohol or drug dependence.
• •17. Has a clear history of neurological or psychiatric disorders, including epilepsy or dementia.
• •18. Pregnant or lactating women.
• •19. The researchers believe that the subjects are not suitable to participate in this clinical study due to other reasons.