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This is a two-arm, randomized, multicenter phase II clinical study to evaluate the efficacy and safety of the Iparomlimab and Tuvonralimab combined with 2 or 4 cycles of chemotherapy as neoadjuvant therapy for resectable stage II-IIIB (N2 only) NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iparomlimab and Tuvonralimab combined with 2 cycles of chemotherapy as neoadjuvant therapy | Experimental | Iparomlimab and Tuvonralimab (5mg/kg Q3W, for 4 cycles) combined with 2 cycles of platinum-based doublet chemotherapy will be administered as neoadjuvant therapy, followed by surgical resection within 6 weeks after completing neoadjuvant therapy. Postoperative adjuvant therapy with the Iparomlimab and Tuvonralimab (5mg/kg, Q3W) for up to 16 cycles may be administered at the investigator's discretion. |
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| Iparomlimab and Tuvonralimab combined with 4 cycles of chemotherapy as neoadjuvant therapy | Experimental | Iparomlimab and Tuvonralimab (5mg/kg Q3W, for 4 cycles) combined with 4 cycles of platinum-based doublet chemotherapy will be administered as neoadjuvant therapy, followed by surgical resection within 6 weeks after completing neoadjuvant therapy. Postoperative adjuvant therapy with the Iparomlimab and Tuvonralimab (5mg/kg, Q3W) for up to 16 cycles may be administered at the investigator's discretion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 2 cycles (Platinum-based doublet chemotherapy) | Drug | Iparomlimab and Tuvonralimab 5mg/kg:5mg/kg,q3W Platinum-based doublet chemotherapy:q3w |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response (pCR) Rate | Pathologic complete response (pCR) rate is defined as the percentage of participants with absence of viable tumor cells in the resected lung tumor bed and lymph nodes. | One week postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathologic Response (MPR) Rate | Major pathologic response (MPR) rate is defined as percentage of participants with ≤10% viable tumor cells in the resected lung tumor bed and lymph nodes. | One week postoperatively |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junye Wang | Contact | 13719229662 | wangjy@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | China |
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| 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 4 cycles (Platinum-based doublet chemotherapy) | Drug | Iparomlimab and Tuvonralimab 5mg/kg:5mg/kg,q3W Platinum-based doublet chemotherapy:q3w |
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Objective Response Rate (ORR) is defined as the percentage of participants with a best response of complete response (CR) or partial response (PR) on preoperative imaging among all subjects who received neoadjuvant therapy and had at least one post-baseline imaging assessment.
| Prior to surgery |
| R0 Resection rate | R0 Resection rate is defined as the percentage of participants who achieve complete surgical resection (R0). | At time of surgery |
| 2-Year Event-Free Survival (EFS) Rate | EFS is defined as the time from the first study treatment to the occurrence of any event, including disease progression or deterioration preventing surgery, inability to achieve gross resection, disease recurrence, or death from any cause. The 2-year EFS rate was estimated using the Kaplan-Meier method. | up to 2 years |
| Disease-free survival (DFS) | Disease-free survival (DFS) is the length of time from postoperative baseline imaging confirmation of no residual disease to disease recurrence or death from any cause, whichever occurs first. | up to 3 years |
| Overall Survival (OS) | Overall Survival (OS) is the length of time after initial administration the participant remains alive. | up to 3 years |
| The Second Affiliated Hospital of Air Force Medical University | Xi'an | China |
| 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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