This is an open-label, multicenter, Phase II clinical study designed to evaluate the safety and efficacy of JSKN033 in the treatment of patients with advanced NSCLC. The study is divided into two phases: Part 1 (Dose Selection) and Part 2 (Cohort Expansion). Enrolled subjects are patients with locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC who are not eligible for curative treatment. Part 1 (Dose Selection): It consists of two dose groups, with a maximum of 20 subjects enrolled in each group. Part 2 (Cohort Expansion): It consists of two cohorts, with a maximum of 60 subjects enrolled in each cohort.
Subjects can understand the informed consent form,voluntarily participate in the study, and sign the informed consent form.
Subjects are≥18 years old on the day of signing the informed consent form, regardless of gender.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Expected survival time ≥3 months.
Presence of any small cell carcinoma component in the histological pathology.
History of other malignant tumors within 5 years prior to the first dose administration.
History of brainstem, meningeal, or spinal cord metastases/compression, or carcinomatous meningitis; presence of active brain metastases.
Imaging during the screening phase shows tumor invasion, compression, or location in surrounding vital organs.