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This randomized phase II exploratory clinical study aims to evaluate the efficacy and safety of SHR-1701 in patients with unresectable stage III non-small cell lung cancer (NSCLC). A total of 84 eligible patients will be randomized 1:1 into an induction immunotherapy group or a consolidation immunotherapy group. Group A will receive SHR-1701 combined with platinum-based chemotherapy as induction therapy followed by concurrent chemoradiotherapy (cCRT) and subsequent SHR-1701 consolidation therapy, while Group B will receive standard cCRT followed by SHR-1701 consolidation therapy. The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1701 induction Group | Experimental | SHR-1701 combined with platinum-doublet chemotherapy induction therapy followed by concurrent chemoradiotherapy and SHR-1701 consolidation therapy. |
|
| Control Group | Active Comparator | Standard concurrent chemoradiotherapy followed by SHR-1701 consolidation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1701 combined with platinum-doublet chemotherapy induction therapy | Drug | SHR-1701 combined with platinum-doublet chemotherapy induction therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 4 years | |
| Disease Control Rate (DCR) | 4 years | |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengfei Zhu | Contact | +8618017312901 | fuscczzf@163.com |
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| SHR-1701 consolidation therapy | Drug | SHR-1701 consolidation therapy |
|
| Platinum-doublet chemotherapy | Drug | Platinum-doublet chemotherapy |
|
| radiotherapy | Radiation | Thoracic concurrent radiotherapy, total dose 60 Gy ±10% |
|
| 4 years |
| Treatment-Related Adverse Events (TRAE) | 4 years |
| Serious Adverse Events (SAE) | 4 years |
| Treatment-Emergent Adverse Events (TEAE) | 4 years |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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