A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients With EGFRm+ Advanced Non-small Cell Lung Cancer

Exclusion Criteria

• •Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor drug treatments within 4 weeks before the first administration of the study drug.
• •Have previously received more than one EGFR-TKI inhibitor;
• •Received other unlisted clinical study drugs or treatments within 4 weeks before the first administration.
• •Received major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first administration, or require elective surgery during the trial period.
• •Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the first use of the study drug.
• •Known active brain metastasis or progression evidence.
• •Other primary malignant tumors within 2 years before the first administration of the study drug.
• •Adverse reactions from previous anti-tumor treatments have not recovered to NCI-CTCAE v5.0 grade ≤1 (except for toxicities judged by the researcher to have no safety risks, such as hair loss, grade 2 peripheral neurotoxicity, and stable thyroid function after hormone replacement therapy).
• •Skin/pressure ulcers, chronic leg ulcers, known active gastric ulcers, or non-healing wounds.
• •History of severe allergies, or allergies to any active or inactive ingredients of the study drug;
• •Severe infections requiring intravenous antibiotic infusion or hospitalization at the time of screening; or uncontrollable active infections within 4 weeks before administration;
• •Known active or suspected autoimmune diseases; or known active ocular diseases (such as active wet age-related macular degeneration, diabetic retinopathy with macular edema);
• •Human immunodeficiency virus (HIV) (HIV1/2 antibody) positive, syphilis spirochete antibody positive .
• •Patients with interstitial lung disease.
• •History of severe cardiovascular diseases.
• •Unable to orally swallow medication, or there is a condition that significantly affects gastrointestinal absorption as judged by the researcher;
• •Clinical intervention is required for pleural effusion, ascites (excluding subjects who do not need drainage and have been stable for more than 2 weeks after drainage).
• •Known alcohol or drug dependence.
• •Mental disorders or poor compliance;
• •Pregnant or lactating women;
• •The investigator believes that the subject has other reasons that make them unsuitable for participating in this clinical study.