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AK112 in Advanced Non-Small Cell Lung Cancer

StatusActive, Not Recruiting
PhasePhase 3
SponsorAkeso
Started2022-11-09
View on ClinicalTrials.gov ↗

Amendment history

2026-03-05
Study Status v5
Completion date2025-12-31→2026-12-31
2025-03-02
Study Status v4
Primary completion dateestimated 2024-06-17→confirmed 2024-01-29
Completion date2025-06-17→2025-12-31
2023-09-17
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v3
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 388→confirmed 398
Study sitesdetails revised at 1 of 1 site
2022-11-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-09-15→confirmed 2022-11-09
Study sitesdetails revised at 1 of 1 site
2022-08-12
Study Identification, Study Status v1
Study title-21 characters
A Phase III Trial of AK112 in Advanced Non-Small Cell Lung Cancer
2022-08-11
Original filing
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%.
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