Comparison of Neoadjuvant Cadonilimab Versus Chemotherapy Combined With PD-1 in the Treatment of Resectable Non-Small Cell Lung Cancer With High PD-L1 Expression: A Single-Center, Randomized, Exploratory Clinical Study

The advent of immunotherapy has changed the treatment landscape for patients with non-small cell lung cancer. It has become the mainstay of perioperative treatment for patients with resectable non-small cell lung cancer。 Cadonilimab is the world's first bispecific antibody drug targeting PD-1 and CTLA-4. Previous studies on AK104 have demonstrated preliminary efficacy in both treatment-naïve advanced NSCLC patients and immunotherapy-resistant patients, showing a favorable safety and tolerability profile. This study aims to evaluate the effectiveness of neoadjuvant bispecific antibody AK104 compared with neoadjuvant chemotherapy combined with a PD-1 inhibitor in the treatment of resectable non-small cell lung cancer (NSCLC) with high PD-L1 expression.

NCT Number	NCT06946836
Lead Sponsor	Shanghai Pulmonary Hospital, Shanghai, China
Conditions	Resectable Non-small Cell Lung Cancer, Bispecific Antibody, Neoadjuvant Therapy
Enrollment	80 participants
Start Date	2025-04-21
Primary Completion	2031-05-01 (estimated)
Study Completion	2031-05-11 (estimated)
Updated on ClinicalTrials.gov	2025-04-27