Actively Recruiting
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 After Chemoradiotherapy
Led by Akeso · Updated on 2025-03-12
560
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of two drugs, AK104 and Sugemalimab, as consolidation therapy for patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) who have not shown disease progression after chemoradiotherapy. This is a Phase III randomized, double-blind study aiming to compare these treatments in a controlled setting to understand their impact on cancer progression and patient outcomes. Participants will be randomly assigned to receive either AK104 or Sugemalimab every three weeks. The study treatments are given intravenously following completion of concurrent or sequential chemoradiotherapy, with strict timing after radiotherapy. No additional consolidation chemotherapy is allowed after radiotherapy, and treatment follows specific dosing and regimen guidelines. During the study, participants will be closely monitored for progression-free survival over three years, along with overall survival, six-month progression-free survival rate, and adverse events up to five years. Assessments include clinical evaluations to track cancer status and safety. The total participation duration can extend up to five years, ensuring long-term follow-up of treatment effects and patient health.
CONDITIONS
Brief Title
A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must voluntarily sign the written informed consent form.
- 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 the first dose.
- Chemotherapy regimens must 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 of over 3 months.
- Adequate organ and bone marrow function.
You will not qualify if you...
- Presence of any small cell lung cancer component in histopathology.
- Currently participating in another interventional clinical study.
- Prior treatment with immunotherapy, biotherapy, anti-angiogenic drugs, or targeted small molecule drugs.
- Clinically significant cardio-cerebrovascular or venous thromboembolic diseases.
- Active prior malignancy within the last 3 years except apparently cured locally curable cancers.
- Tumor invading important vessels or organs.
- Acute exacerbation of chronic obstructive pulmonary disease or asthma within 4 weeks before the first dose.
- Presence of interstitial lung disease requiring treatment.
- Unresolved toxicities from prior anticancer therapy above Grade 1.
- Severe infection within 4 weeks prior to the first dose.
- Major surgery or severe trauma within 4 weeks before the first dose.
- Use of systemic corticosteroids (>10 mg prednisone daily or equivalent) or immunosuppressive agents within 14 days before the first dose.
- Active or history of autoimmune diseases that may relapse.
- History of severe hypersensitivity to monoclonal antibodies.
- Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive either AK104 or Sugemalimab as consolidation therapy after chemoradiotherapy.
Visits every 3 weeks during treatment
Duration - Up to 2 years after treatment
Participants are monitored for progression-free survival, overall survival, and adverse events after treatment ends.
Regular follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Cancer Hospital of Shandong First Medical University
Jinan, China
Actively Recruiting
Research Team
T
Ting Liu, MD
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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