Search / Trial NCT06617416

A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC

Launched by AKESO · Sep 25, 2024

Trial Information

Current as of December 22, 2024

Not yet recruiting

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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. 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 60Gy±10% (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 ≤ 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.

Trial Officials

Jinming Yu, MD

Principal Investigator

Shandong Cancer Hospital and Institute

About Akeso

Akeso, Inc. is a leading biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for the treatment of cancer and autoimmune diseases. With a robust pipeline of monoclonal antibodies and targeted therapies, Akeso leverages cutting-edge research and advanced biotechnological platforms to address unmet medical needs. Committed to improving patient outcomes, Akeso's clinical trials focus on delivering effective and safe treatment options while adhering to the highest standards of regulatory compliance and ethical practices. The company is driven by a mission to transform the landscape of modern medicine through scientific excellence and collaboration.

Locations

Jinan, , China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0