2345 - A Prospective, Phase II, Single-Arm Trial Evaluating Efficacy and Safety of the Regimen of Induction Cadonilimab plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Cadonilimab Therapy for Unresectable Stage III NSCLC
Presenter(s)
L. CHU1, R. Ye2, J. Ni3, X. Yang4, X. Chu1, H. Chen2, S. Yu2, and Z. Zhu4; 1Fudan University Shanghai Cancer Center, Shanghai, China, 2Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China, 3Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China, 4Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
Purpose/Objective(s): Concurrent chemoradiotherapy (cCRT) remains the standard treatment for patients with unresectable stage III NSCLC. Evidence from the PACIFIC study, immunotherapy has recently become a main-stream treatment option following cCRT. Cadonilimab, a bispecific antibody targeting both PD-1 and CTLA-4, has shown promising results in multiple clinical trials, demonstrating favorable safety, tolerability, and anti-tumor efficacy. In this prospective trial, we will investigate the efficacy and safety of cadonilimab for induction and consolidative therapy in patients with stage III unresectable NSCLC receiving cCRT.
Materials/Methods: This prospective, phase II, single-arm study will recruit up to 41 patients of age 18 years and older, with an ECOG 0-1, confirmed by histology/cytology as unresectable stage III NSCLC without actionable driven genes (EGFR/ALK/ROS1). Patients who had histologically confirmed mixed SCLC or NSCLC would be excluded. The study includes an induction therapy which included 2 cycles of treatment with cadonilimab combined with cisplatin/carboplatin (cisplatin 25 mg/m² d1-3 IV or carboplatin with AUC 5 IV d1, every 3 weeks) plus etoposide (100 mg/m² d1-3), followed by cCRT (Radiotherapy 60 Gy ±10% in 30 fractions. Chemotherapy: etoposide 50 mg/m² IV on days 43-47 and 71-75, and cisplatin 50 mg/m² IV on days 43, 50, 71, and 78 or carboplatin with AUC 2 IV weekly for 6 weeks). The patients will receive consolidative therapy with cadonilimab 10 mg/kg IV every 3 weeks within 6 weeks after completion of cCRT for up to 1 year or until progression, or unacceptable toxicity. The primary endpoints are the 1-year PFS rate in the ITT population and the 1-year PFS rate in patients who have completed cCRT and initiated consolidative therapy. Secondary endpoints include pre-cCRT ORR, ORR, pre-cCRT DCR, the proportion of patients receiving consolidative therapy, OS, PFS, and toxicity. Adverse effects are graded per CTCAE v.5.0. The first patient had been enrolled in August 2024.
Results: TBD.
Conclusion: TBD.