A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC

NCT06617416 | Recruiting Phase 3 DMC

• 1 other identifier: AK104-309
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC (Non-small Cell Lung Cancer)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• OS

  5 years

• 6-month PFS rate assessed by INV

  3 years

• AEs

  3 years

Study Arms (2)

AK104 group

EXPERIMENTAL

AK104 Q3W

Drug: Cadonilimab (AK104)

Sugemalimab group

ACTIVE COMPARATOR

Sugemalimab 1200mg Q3W

Drug: Sugemalimab

Interventions

Cadonilimab (AK104) DRUG

AK104 ivgtt Q3W

AK104 group

Sugemalimab DRUG

1200mg Q3W

Sugemalimab group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must sign the written informed consent form (ICF) voluntarily.
• Age ≥18 years.
• Histologically or cytologically confirmed unresectable locally advanced (Stage III) NSCLC.
• Absence of known EGFR sensitive mutations and negative for ALK and ROS1 fusions.
• Concurrent or sequential chemoradiotherapy completed 1 to 42 days prior to the first dose.
• Chemotherapy regimens should be in accordance with current clinical guidelines.
• Consolidation chemotherapy is not allowed after radiotherapy.
• Total dose of radiotherapy is 60Gy±10% (54Gy-66Gy).
• No disease progression after concurrent or sequential chemoradiotherapy.
• ECOG performance status score of 0-1.
• Expected survival of over 3 months.
• Adequate organ and bone marrow function.

You may not qualify if:

• The histopathology contains any component of small cell lung cancer.
• Currently participating in another interventional clinical study.
• Previously received immunotherapy, biotherapy, anti-angiogenic drugs, or small molecule targeted drugs.
• Patients with clinically significant cardio-cerebrovascular or venous thromboembolic diseases.
• Prior malignancy active within the previous 3 years except for the locally curable cancers that have been apparently cured.
• Tumor invades important vessels or organs.
• Experienced acute exacerbation of chronic obstructive pulmonary disease or asthma within 4 weeks prior to the first dose.
• Presence of interstitial lung disease that requires treatment.
• Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).
• Experienced severe infection within 4 weeks prior to the first dose.
• Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose.
• 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.
• Active autoimmune diseases or history of autoimmune diseases that may relapse.
• Previous history of severe hypersensitivity reactions to other monoclonal antibodies.
• Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Cancer Hospital of Shandong First Medical University

Jinan, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sugemalimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jinming Yu, MD

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Liu, MD

CONTACT

+86-0760-89873925; clinicaltrials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)