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Clinical Trial NCT06617416 for NSCLC (Non-small Cell Lung Cancer) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC Phase 3 560

Recruiting
Clinical Trial NCT06617416 is designed to study Treatment for NSCLC (Non-small Cell Lung Cancer). It is a Phase 3 interventional study that is recruiting, having started on November 12, 2024, with plans to enroll 560 participants. Led by Akeso, it is expected to complete by December 30, 2028. The latest data from ClinicalTrials.gov was last updated on March 12, 2025.
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.
Official Title

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 Who Have Not Progressed After Concurrent or Sequential Chemoradiotherapy

Conditions
NSCLC (Non-small Cell Lung Cancer)
Other Study IDs
  • AK104-309
NCT ID Number
NCT06617416
Start Date (Actual)
2024-11-12
Last Update Posted
2025-03-12
Completion Date (Estimated)
2028-12-30
Enrollment (Estimated)
560
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalAK104 group
AK104 Q3W
Cadonilimab (AK104)
AK104 ivgtt Q3W
Active ComparatorSugemalimab group
Sugemalimab 1200mg Q3W
Sugemalimab
1200mg Q3W
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Progression-free survival (PFS) assessed by INV
PFS is defined as the time from randomization until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1).
3 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
OS
Time from randomization to death
5 years
6-month PFS rate assessed by INV
PFS rate at 6 months
3 years
AEs
Adverse events incidence and severity, clinically significant abnormal laboratory test results.
3 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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.
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Study Central Contact
Contact: Ting Liu, MD, +86-0760-89873925, [email protected]
1 Study Locations in 1 Countries
Cancer Hospital of Shandong First Medical University, Jinan, China
Jinming Yu, MD, Contact, +86-0531-87984777, [email protected]
Recruiting