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This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of adjuvant Toripalimab therapy in completely resected stage IA2-IB non-squamous NSCLC with high-risk factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toripalimab adjuvant therapy group | Experimental | Patients must be enrolled within 8 weeks of complete surgical excision and receive Toripalimab at a dose of 240 mg intravenously (IV) once every 3 weeks for a planned duration of 1 years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab | Drug | This is a prospective, open, single-center, single-arm phase II clinical study with no driver mutations identified in the central laboratory,to evaluate the efficacy and safety of adjuvant Toripalimab therapy in completely resected stage IA2-IB non-squamous NSCLC with high-risk factors. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year DFS rate | DFS is defined as time from randomization to disease recurrence (determined by CT or MRI scan and/or pathologic disease on biopsy) or death (from any cause) by investigator assessment. 3-year DFS rate is Disease-Free Survival at 3 Years. | From date of randomisation up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| DFS | DFS is defined as time from randomization to disease recurrence (determined by CT or MRI scan and/or pathologic disease on biopsy) or death (from any cause) by investigator assessment. | From date of randomisation up to approximately 10 years |
| 3-year OS rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongsheng Yue | Contact | +8602223109106 | yuedongsheng_cg@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Dongsheng Yue | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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Defined as the percentage of patients alive at 3 years, respectively, estimated from a Kaplan Meier plot of OS at the time of the primary analysis |
| From date of randomization up to approximately 5 years |
| 5-year OS rate | Defined as the percentage of patients alive at 5 years, respectively, estimated from a Kaplan Meier plot of OS at the time of the primary analysis | From date of randomization up to approximately 5 years |
| OS | OS is defined as the time from the date of randomisation until death due to any cause. | From date of randomization up to approximately 10 years |
| Safety and tolerability in overall population | AEs graded by CTCAE version 5.0 | From date of randomisation up to approximately 10 years |