RecruitingPhase 3NCT06617416

A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC

A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Consolidation Therapy of AK104 Versus Sugemalimab in Patients With Unresectable Locally Advanced Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent or Sequential Chemoradiotherapy


Sponsor

Akeso

Enrollment

560 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study compares the efficacy and safety of AK104 versus Sugemalimab as consolidation therapy in patients with unresectable, locally advanced NSCLC who have not progressed following concurrent or sequential chemoradiotherapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing AK104 — a bispecific antibody that blocks two immune checkpoint proteins at once (PD-1 and CTLA-4) — as a maintenance treatment in patients with stage III non-small cell lung cancer (NSCLC) that cannot be surgically removed. AK104 is given after standard chemoradiotherapy to try to prevent the cancer from coming back. **You may be eligible if...** - You are 18 or older - You have been confirmed to have stage III NSCLC that cannot be surgically removed - Your tumor does not have EGFR mutations or ALK/ROS1 fusions - You completed chemoradiotherapy 1 to 42 days before starting treatment - Your cancer did not progress after completing chemoradiotherapy - You received the right radiation dose (around 60 Gy) - You are in good general health (ECOG score 0–1) and have adequate organ function **You may NOT be eligible if...** - Your cancer has EGFR mutations or ALK/ROS1 gene fusions - Your cancer progressed after chemoradiotherapy - You have active autoimmune disease or serious lung inflammation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCadonilimab (AK104)

AK104 ivgtt Q3W

DRUGSugemalimab

1200mg Q3W


Locations(1)

Cancer Hospital of Shandong First Medical University

Jinan, China

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NCT06617416


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