A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Trial Parameters
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Brief Summary
The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with osimertinib as first-Line treatment for patients with epidermal growth factor receptor (EGFR) mutations, locally advanced or metastatic non-squamous non-small cell lung cancer.
Eligibility Criteria
Inclusion Criteria: 1. Aged ≥18 years to ≤75 years at the time of signing the informed consent form (ICF), regardless of gender. 2. Histologically or cytologically confirmed non-squamous NSCLC that is locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC not eligible to radical surgery and/or radical radiotherapy. 3. No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. 4. Histologically or cytologically confirmed EGFR-sensitive mutations. 5. Tumor tissue samples obtained at or after the diagnosis of locally advanced or metastatic tumor are eligible. 6. At least one target lesion assessed by the investigator based on RECIST v1.1. 7. ECOG performance status score of 0 or 1 within 7 days prior to randomization. 8. Life expectancy ≥ 12 weeks. 9. Adequate organ and bone marrow function. Exclusion Criteria: 1. Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components