Comparing AK104 and Sugemalimab for advanced lung cancer treatment

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 is testing whether a new treatment called AK104 works better than Sugemalimab for people with advanced lung cancer who haven't seen their disease get worse after chemotherapy and radiation.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 560 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Akeso (Industry-sponsored)
• Drugs / interventions: Chemotherapy, immunotherapy, prednisone, Sugemalimab
• Locations: 1 site (Jinan)
• Trial ID: NCT06617416 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of AK104 compared to Sugemalimab as a consolidation therapy for patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) who have not shown disease progression after receiving chemoradiotherapy. Participants must have completed their treatment within a specific timeframe and meet certain health criteria. The study aims to determine which treatment provides better outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable locally advanced NSCLC who have completed chemoradiotherapy without disease progression.

Not a fit: Patients with small cell lung cancer or those currently participating in another clinical study may not benefit from this trial.

Why it matters

Potential benefit: If successful, this study could offer a more effective treatment option for patients with advanced lung cancer.

How similar studies have performed: Other studies have shown promise in using similar immunotherapy approaches for lung cancer, indicating potential for success in this trial.

Eligibility criteria

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.

Where this trial is running

Jinan

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

Study contacts

• Principal investigator: Jinming Yu, MD — Shandong Cancer Hospital and Institute
• Study coordinator: Ting Liu, MD

Conditions NSCLC