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

Name: A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy — clinical trial record (NCT07010263)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: AK112-311

StatusRecruiting

PhasePhase 3

SponsorAkeso

Started2025-06-13

View on ClinicalTrials.gov ↗

Amendment history

2026-03-04

Not Yet Recruiting→Recruiting Study Status, Study Design, Outcome Measures, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2025-05-29→confirmed 2025-06-13

Enrollment target480→560

Study sites42→53

Secondary endpoints9 to 8 entries

~~Overall Survival (OS)~~

Primary endpoints1 to 2 entries

Overall Survival (OS)

2025-06-05

Original filing

Akeso

96 trials monitored

See 1 trial at risk

Lung Cancer

4,033 trials monitored

See 210 trials at risk

Small Cell Lung Cancer

539 trials monitored

See 30 trials at risk

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.

Trial Details

NCT Number	NCT07010263
Lead Sponsor	Akeso
Conditions	Small Cell Lung Cancer
Enrollment	560 participants
Start Date	2025-06-13
Primary Completion	2028-12-31 (estimated)
Study Completion	2029-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-05