Clinical Trial

AK112 in Advanced Non-Small Cell Lung Cancer

Active, Not Recruiting Phase 3
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Summary
This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 comparing Pembrolizumab in subjects with advanced NSCLC whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-08-11; most recent amendment 2026-03-05.
Status change: Recruiting → Active, Not Recruiting 2023-09-17
Status change: Not Yet Recruiting → Recruiting 2022-11-09
Trial Details
NCT Number NCT05499390
Lead Sponsor Akeso
Conditions Advanced Non-small-cell Lung Cancer
Enrollment 398 participants
Start Date 2022-11-09
Primary Completion 2024-01-29 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-09