A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC

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

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC (Non-small Cell Lung Cancer)
• Intervention / Treatment: Drug: Cadonilimab (AK104); Drug: Sugemalimab

• Study Type: Interventional
• Enrollment (Estimated): 560
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ting Liu, MD; Phone Number: +86-0760-89873925; Email: clinicaltrials@akesobio.com

Study Locations

• China
  • Jinan, China
    • Recruiting
    • Cancer Hospital of Shandong First Medical University
    • Contact: Jinming Yu, MD; Phone Number: +86-0531-87984777; Email: sdzlllh803@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AK104 group; AK104 Q3W	Drug: Cadonilimab (AK104); AK104 ivgtt Q3W
Active Comparator: Sugemalimab group; Sugemalimab 1200mg Q3W	Drug: Sugemalimab; 1200mg Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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 Measure	Measure Description	Time 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

Collaborators and Investigators

• Sponsor: Akeso
• Investigators: Principal Investigator: Jinming Yu, MD, Shandong Cancer Hospital and Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: AK104-309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No