A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC

Akeso

Status and phase: Enrolling; Phase 3

Conditions: NSCLC (Non-small Cell Lung Cancer)

Treatments: Drug: Sugemalimab; Drug: Cadonilimab (AK104)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06617416

AK104-309

Details and patient eligibility

About

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.

Enrollment: 560 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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560 participants in 2 patient groups

AK104 group

Experimental group

Description:

AK104 Q3W

Treatment:

Drug: Cadonilimab (AK104)

Sugemalimab group

Active Comparator group

Description:

Sugemalimab 1200mg Q3W

Treatment:

Drug: Sugemalimab