NCT06617416 A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC
| NCT ID | NCT06617416 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Akeso |
| Condition | NSCLC (Non-small Cell Lung Cancer) |
| Study Type | INTERVENTIONAL |
| Enrollment | 560 participants |
| Start Date | 2024-11-12 |
| Primary Completion | 2026-10-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 560 participants in total. It began in 2024-11-12 with a primary completion date of 2026-10-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Jinming Yu, MD
PRINCIPAL INVESTIGATOR
Shandong Cancer Hospital and Institute
Frequently Asked Questions
Who can join the NCT06617416 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NSCLC (Non-small Cell Lung Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06617416 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 560 participants.
Is NCT06617416 currently recruiting?
Yes, NCT06617416 is actively recruiting participants. Contact the research team at clinicaltrials@akesobio.com for enrollment information.
Where is the NCT06617416 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06617416 clinical trial?
NCT06617416 is sponsored by Akeso. The principal investigator is Jinming Yu, MD at Shandong Cancer Hospital and Institute. The trial plans to enroll 560 participants.
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