Phase 3 Study Comparing AK104 and Sugemalimab as Consolidation Therapy in Patients with Unresectable Locally Advanced Non-Small Cell Lung Cancer After Chemoradiotherapy

What this Trial Is About

Researchers are evaluating the effectiveness and safety of two drugs, AK104 and Sugemalimab, as consolidation therapy for patients with unresectable, locally advanced non-small cell lung cancer NSCLC who have not shown disease progression after chemoradiotherapy. This is a Phase III randomized, double-blind study aiming to compare these treatments in a controlled setting to understand their impact on cancer progression and patient outcomes. Participants will be randomly assigned to receive either AK104 or Sugemalimab every three weeks. The study treatments are given intravenously following completion of concurrent or sequential chemoradiotherapy, with strict timing after radiotherapy. No additional consolidation chemotherapy is allowed after radiotherapy, and treatment follows specific dosing and regimen guidelines. During the study, participants will be closely monitored for progression-free survival over three years, along with overall survival, six-month progression-free survival rate, and adverse events up to five years. Assessments include clinical evaluations to track cancer status and safety. The total participation duration can extend up to five years, ensuring long-term follow-up of treatment effects and patient health.

A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC