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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK104 group | Experimental | AK104 Q3W |
|
| Sugemalimab group | Active Comparator | Sugemalimab 1200mg Q3W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cadonilimab (AK104) | Drug | AK104 ivgtt Q3W |
| |
| Sugemalimab |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) assessed by INV | 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). | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Time from randomization to death | 5 years |
| 6-month PFS rate assessed by INV | PFS rate at 6 months | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Liu, MD | Contact | +86-0760-89873925 | clinicaltrials@akesobio.com |
| Name | Affiliation | Role |
|---|---|---|
| Jinming Yu, MD | Shandong Cancer Hospital and Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of Shandong First Medical University | Recruiting | Jinan | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000723018 | sugemalimab |
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| Drug |
1200mg Q3W |
|
| AEs | Adverse events incidence and severity, clinically significant abnormal laboratory test results. | 3 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |