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

Sponsor
Akeso
Study ID
NCT07010263
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AK112 — DRUG
    AK112 20mg/kg, intravenous \[IV\]),Q3W
  • Placebo — OTHER
    Placebo, intravenous \[IV\]),Q3W

Study Details

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.

Key Dates

First listed
Jun 8, 2025
Start date
Jun 13, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
560 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ak112 arm
    AK112 intravenous \[IV\]),every 3 weeks
  • Placebo Comparator: Placebo arm
    Placebo intravenous \[IV\]),every 3 weeks

Primary Outcome Measure

Progression-Free Survival(PFS) assessed by Blinded independent center review(BIRC) [ Time Frame: Approximately 6 years ]

Central Contacts

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