Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC

Prior treatment

• Subjects with other malignant tumors within 5 years prior to enrollment, and other tumors have been cured through local therapy, such as cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-primary invasive bladder cancer, and prostate/cervical/breast cancer in situ.
• Adequate washout of previous therapy before the first dose.
• Prior treatment with topoisomerase I inhibitors (e.g., irinotecan, topotecan), antibody-drug conjugates containing topoisomerase I inhibitors (e.g., DS-8201, HER3-DXd, DS-1062), or targeting TROP2 or HER3.
• Previous treatment with docetaxel.
• Previous history of allogeneic bone marrow or organ transplantation.
• Known allergy to any component of the study drug, and previous history of severe allergic reaction to other antibody drugs.

Other illness

• Presence of brainstem, meningeal metastases, spinal cord metastases or compression, leptomeningeal metastases, or history of carcinomatous meningitis; Presence of active brain metastases.
• During the screening period, imaging shows that the tumor invades, compresses, or occurs in the surrounding important organs (such as the heart and pericardium, trachea, esophagus, superior vena cava, etc.) or there is a risk of esophageal tracheal fistula or esophageal pleural fistula.
• Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
• Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
• Have an uncontrolled infection, a history of immunodeficiency, a positive human immunodeficiency virus (HIV) test, or a history of AIDS.
• Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risk and/or uncertainty in survival evaluation, such as tumor leukemia response , cachexia manifestations, etc.

Other

• Presence of any small cell carcinoma component in histopathology.
• Gastrointestinal abnormalities with obvious clinical manifestations.
• Pregnant and/or lactating females.

• Voluntarily participate and sign the informed consent form.
• Age ≥ 18 years old, ≤ 75 years old, male or female.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
• Expected survival ≥ 3 months.
• Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not suitable for radical surgery and/or radical radiotherapy.
• At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
• Recently archived or fresh tumor tissue samples are available.
• Have good organ function.
• Have no current birth plans and agree to contraception during the trial.