A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC

Phase 3

Recruiting

• Conditions: NSCLC (Non-small Cell Lung Cancer)
• Interventions: Drug: Cadonilimab (AK104); Drug: Sugemalimab

• Registration Number: NCT06617416
• Lead Sponsor: Akeso

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-09-25
• Study First Posted: 2024-09-27
• Study Start: 2024-11-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12
• Primary Completion: 2026-10-28
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 560

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK104 group	Cadonilimab (AK104)	AK104 Q3W
Sugemalimab group	Sugemalimab	Sugemalimab 1200mg Q3W

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) assessed by INV	3 years	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).

Secondary Outcome Measures

Name	Time	Method
OS	5 years	Time from randomization to death
6-month PFS rate assessed by INV	3 years	PFS rate at 6 months
AEs	3 years	Adverse events incidence and severity, clinically significant abnormal laboratory test results.

Trial Locations

Locations (1)

Cancer Hospital of Shandong First Medical University; 🇨🇳 Jinan, China