NCT06617416RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 12 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 560 (estimated)
- First submitted
- 25 Sept 2024
- Start date
- 12 Nov 2024
- Primary completion date
- 28 Oct 2026
- Lead sponsor
- Akeso
- Diseases
- Lung cancer
- NCT number
- NCT06617416
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 560
- From 12 Nov 2024 to the primary completion date, 28 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously received immunotherapy, biotherapy, anti-angiogenic drugs, or small molecule targeted drugs.
- Experienced acute exacerbation of chronic obstructive pulmonary disease or asthma within 4 weeks prior to the first dose.
- 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.
- Previous history of severe hypersensitivity reactions to other monoclonal antibodies.
- Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.
Other illness
- The histopathology contains any component of small cell lung cancer.
- 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.
- Presence of interstitial lung disease that requires treatment.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
Other
- Currently participating in another interventional clinical study.
- Tumor invades important vessels or organs.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.