A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC

Ki vehet részt

• ≥Age 18, gender is not limited
• Locally advanced or metastatic NSCLC confirmed by pathology
• Patients who have been genetically tested to carry EGFR sensitive mutations
• Blood/Tissue samples must be provided for testing
• Must have a minimum life expectancy of >= 3 months
• At least one measurable tumor lesion according to RECIST version 1.1; ● Previous radiotherapy-treated lesions cannot be used as target lesions unless imaging studies show clear progression of the lesions
• Physical Status (ECOG PS) score was 0-1
• Have full organ function
• Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method
• Subjects are required to give informed consent to this study before the experiment and sign a written informed consent voluntarily

Ki nem vehet részt

• 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
• 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 drugs
• 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)
• Severe infections requiring intravenous antibiotic infusion or hospitalization at the time of screening; or uncontrollable active infections within 4 weeks before administration
• Known alcohol or drug dependence
• History of severe allergies, or allergies to any active or inactive ingredients of the study drug
• 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)
• Mental disorders or poor compliance
• Have previously received more than two EGFR-TKI inhibitors for part A
• Known active or suspected autoimmune diseases; or known active ocular diseases (such as active wet age-related macular degeneration, diabetic retinopathy with macular edema)
• Skin/pressure ulcers, chronic leg ulcers, known active gastric ulcers, or non-healing wounds
• Pregnant or lactating women
• The investigator believes that the subject has other reasons that make them unsuitable for participating in this clinical study