A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC

Recruiting now · Phase 3

Conditions studied: NSCLC (Non-small Cell Lung Cancer)

In brief

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.

Key facts

Study ID

NCT06617416

Run by

Akeso

People needed

560

Starts

2024-11-12

Expected to finish

2028-12-30

Last updated by the study team

2025-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Cancer Hospital of Shandong First Medical University — Jinan, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.