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โ† Trials
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A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC

RecruitingPhase 3Ages 18 Years - anyAllAkeso
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Subjects must sign the written informed consent form (ICF) voluntarily. 2. Age โ‰ฅ18 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. Concurrent or sequential chemoradiotherapy completed 1 to 42 days prior to the first dose. 6. Chemotherapy regimens should be in accordance with current clinical guidelines. 7. Consolidation chemotherapy is not allowed after radiotherapy. 8. Total dose of radiotherapy is 60Gyยฑ10% (54Gy-66Gy). 9. No disease progression after concurrent or sequential chemoradiotherapy. 10. ECOG performance status score of 0-1. 11. Expected survival of over 3 months. 12. Adequate organ and bone marrow function. Exclusion Criteria: 1. The histopathology contains any component of small cell lung cancer. 2. Currently participating in another interventional clinical study. 3. Previously received immunotherapy, biotherapy, anti-angiogenic drugs, or small molecule targeted drugs. 4. Patients with clinically significant cardio-cerebrovascular or venous thromboembolic diseases. 5. Prior malignancy active within the previous 3 years except for the locally curable cancers that have been apparently cured. 6. Tumor invades important vessels or organs. 7. Experienced acute exacerbation of chronic obstructive pulmonary disease or asthma within 4 weeks prior to the first dose. 8. Presence of interstitial lung disease that requires treatment. 9. Toxicities of prior anticancer therapy have not resolved to โ‰ค Grade 1 (NCI-CTCAE version 5.0). 10. Experienced severe infection within 4 weeks prior to the first dose. 11. Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose. 12. Any condition that required systemic treatment with corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose. 13. Active autoimmune diseases or history of autoimmune diseases that may relapse. 14. Previous history of severe hypersensitivity reactions to other monoclonal antibodies. 15. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.
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What it tests

  • Cadonilimab (AK104)
  • Sugemalimab
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Where

1 site
Cancer Hospital of Shandong First Medical University
Jinan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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