A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC
Recruiting
Phase 3
Interventional Study
NSCLC (Non-small Cell Lung Cancer)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 560 (estimated)
- Sponsor
- Akeso · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Subjects must sign the written informed consent form (ICF) voluntarily.
2. Age ≥18 years.
3. Histologically or cytologically confirmed unresectable locally advanced (Stage III) NSCLC.
4. Absence of known EGFR sensitive mutations and negative for ALK and ROS1 fusions.
5. Concu…
Contacts