Actively Recruiting
A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC
Led by Akeso · Updated on 2025-03-12
560
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent form voluntarily
- Age 18 years or older
- Histologically or cytologically confirmed unresectable locally advanced (Stage III) NSCLC
- No known EGFR sensitive mutations and negative for ALK and ROS1 fusions
- Completed concurrent or sequential chemoradiotherapy 1 to 42 days before first dose
- Chemotherapy regimens follow current clinical guidelines
- No consolidation chemotherapy allowed after radiotherapy
- Total radiotherapy dose between 54Gy and 66Gy
- No disease progression after chemoradiotherapy
- ECOG performance status score of 0 or 1
- Expected survival over 3 months
- Adequate organ and bone marrow function
You will not qualify if you...
- Histopathology includes any small cell lung cancer component
- Currently participating in another interventional clinical study
- Prior treatment with immunotherapy, biotherapy, anti-angiogenic drugs, or small molecule targeted drugs
- Clinically significant cardio-cerebrovascular or venous thromboembolic diseases
- Active malignancy within previous 3 years except cured locally curable cancers
- Tumor invading important vessels or organs
- Acute exacerbation of COPD or asthma within 4 weeks before first dose
- Interstitial lung disease requiring treatment
- Unresolved toxicities from prior anticancer therapy above Grade 1
- Severe infection within 4 weeks before first dose
- Major surgery or severe trauma within 4 weeks before first dose
- Systemic corticosteroid or immunosuppressive treatment within 14 days before first dose
- Active or history of autoimmune diseases that may relapse
- History of severe hypersensitivity to monoclonal antibodies
- Previous organ or allogeneic hematopoietic stem cell transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital of Shandong First Medical University
Jinan, China
Actively Recruiting
Research Team
T
Ting Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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