NCT07010263

A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy

A Multicenter, Randomized, Double-blind, Phase III Clinical Study of Comparing the Efficacy and Safety of AK112 (PD-1/VEGF Bispecific Antibody) Versus Placebo as Consolidation Treatment for Patients With Limited Stage Small-Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK112 to placebo as consolidation treatment for patients with limited stage small cell lung cancer who have not progressed following concurrent chemoradiation therapy.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	AK112	AK112 20mg/kg, intravenous \[IV\]),Q3W
OTHER	Placebo	Placebo, intravenous \[IV\]),Q3W

Timeline

• Start date: 2025-06-13
• Primary completion: 2028-12-31
• Completion: 2029-07-31
• First posted: 2025-06-08
• Last updated: 2026-03-05

Locations

53 sites across 1 country: China