Cadonilimab Plus Chemotherapy as First-line Treatment for PD-L1 Negative NSCLC

LungCadX is a multi-center, open-label, single-arm, investigator initiated, phase Ⅱ study. Patients received cadonilimab (10 mg/kg, IV, every 3 weeks) plus platinum-based chemotherapy (carboplatin \[area under the curve (AUC) 5 mg/mL per min, IV\] and paclitaxel \[175 mg/m2, IV\] for squamous NSCLC, or carboplatin \[AUC 5 mg/mL per min, IV\] and pemetrexed \[500 mg/m2, IV\] for non-squamous NSCLC) for up to four cycles, followed by maintenance therapy with cadonilimab for squamous NSCLC, and intravenous cadonilimab plus pemetrexed for non-squamous NSCLC. The primary endpoint was 12-month PFS rate by investigator assessment per RECIST 1.1. Secondary endpoints included PFS, OS, ORR，DoR，DCR, and the safety. Exploratory objective was to assess blood/tumor/urine/faeces tissue for potential biomarkers study. Adverse events will be monitored throughout the trial and graded according to the CTCAE v5.0.