NSCLC (Non-small Cell Lung Cancer)
Conditions
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.
Interventions
AK104 ivgtt Q3W
DRUGSugemalimab
1200mg Q3W
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) assessed by INV | 3 years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 5 years | Time from randomization to death |
| 6-month PFS rate assessed by INV | 3 years | PFS rate at 6 months |
| AEs | 3 years | Adverse events incidence and severity, clinically significant abnormal laboratory test results. |
Countries
China
Contacts
Primary ContactTing Liu, MD
Outcome results
None listed