A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Consolidation Therapy of AK104 Versus Sugemalimab in Patients With Unresectable Locally Advanced Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent or Sequential Chemoradiotherapy
This study compares the efficacy and safety of AK104 versus Sugemalimab as consolidation therapy in patients with unresectable, locally advanced NSCLC who have not progressed following concurrent or sequential chemoradiotherapy.
• Subjects must sign the written informed consent form (ICF) voluntarily.
• Age ≥18 years.
• Histologically or cytologically confirmed unresectable locally advanced (Stage III) NSCLC.
• Absence of known EGFR sensitive mutations and negative for ALK and ROS1 fusions.
• Concurrent or sequential chemoradiotherapy completed 1 to 42 days prior to the first dose.
• Chemotherapy regimens should be in accordance with current clinical guidelines.
• Consolidation chemotherapy is not allowed after radiotherapy.
• Total dose of radiotherapy is 60Gy±10% (54Gy-66Gy).
• No disease progression after concurrent or sequential chemoradiotherapy.
⁃ ECOG performance status score of 0-1.
⁃ Expected survival of over 3 months.
⁃ Adequate organ and bone marrow function.