Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer

Inclusion criteria

• Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
• Age ≥ 18 years old and ≤ 75 years old at the time of randomization.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Expected life expectancy of at least 3 months.
• Histologically or cytologically confirmed diagnosis of NSCLC.
• Locally advanced or metastatic NSCLC (American Joint Committee on Cancer [AJCC] 8th edition).
• Previously received systemic platinum-based chemotherapy and PD-1/L1 inhibitors.
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• Adequate organ function.

Exclusion criteria

• Histologic or cytopathologic evidence of the presence of small cell lung carcinoma.
• Other malignancies within 3 years prior to randomization.
• Known actionable genomic alterations.
• Prior administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors.
• Previous treatment with docetaxel.
• History of severe bleeding tendency or coagulation dysfunction.
• Active autoimmune disease requiring systemic therapy within 2 years prior to randomization.
• History of myocarditis, cardiomyopathy, and malignant arrhythmia.