SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer

This is an open-label, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.

Inclusion Criteria: * Histologically or cytologically confirmed locally advanced or metastatic NSCLC * Without epidermal growth factor receptor (EGFR) sensitizing mutation, and anaplastic lymphoma kinase (ALK) fusion gene. * Provide a tumor tissue sample. * At least one measurable lesion as assessed by the investigator according to RECIST v1.1. * ECOG performance status of 0 or 1. * Life expectancy ≥ 12 weeks. * Adequate bone marrow, liver, kidney, and coagulation function. * Male and female participants must agree to use highly effective methods of contraception during the specified period of the study. Exclusion Criteria: * Histologically or cytologically confirmed co-existing small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components. * Participants with known metastases to meninges, brainstem metastases, metastases to spinal cord and/or compression, or active metastases to central nervous system (CNS). * Uncontrolled systemic disease as judged by the investigator. * Presence of uncontrolled, clinically symptomatic, or requiring repeated drainage pleural effusion, pericardial effusion, or ascites. * Presence of other moderate to severe lung disorders. * History of haemorrhagic diathesis or coagulopathy and/or clinically significant bleeding symptoms or risks. * Previous or co-existing gastrointestinal diseases, surgery, and wound healing complications. * Active hepatitis b or hepatitis c or co-infection with HBV and HCV. * Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation. * Known hypersensitivity to the study drug or any of its components. * Pregnant or lactating women.