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This is a randomized, open-label, multi-center Phase III clinical study aimed at head-to-head evaluating the clinical efficacy of three immunotherapy strategies, namely perioperative immunotherapy, neoadjuvant immunotherapy, and adjuvant immunotherapy using Toripalimab, in patients with resectable stage II-IIIA non-small cell lung cancer (NSCLC) without EGFR/ALK mutations. This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1030.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perioperative immunotherapy | Experimental | After randomization, patients will receive neoadjuvant treatment with three cycles of Toripalimab combined with platinum-based doublet chemotherapy, one cycle per 3 weeks and the drug administered on the first day of each cycle. Radical surgery will be performed within 4-6 weeks after completing the three cycles of neoadjuvant treatment. Subjects who have undergone radical surgery will receive one cycle of adjuvant treatment with Toripalimab combined with platinum-based doublet chemotherapy post-surgery, followed by 13 cycles of maintenance treatment with Toripalimab, one cycle per 3 weeks and the drug administered on the first day of each cycle |
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| Neoadjuvant immunotherapy | Active Comparator | After randomization, patients will receive neoadjuvant treatment with three cycles of Toripalimab combined with platinum-based doublet chemotherapy, one cycle per 3 weeks and the drug administered on the first day of each cycle. Radical surgery will be performed within 4-6 weeks after completing the three cycles of neoadjuvant treatment. Subjects who have undergone radical surgery will selectively receive adjuvant chemotherapy with or without radiation therapy post-surgery |
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| Adjuvant immunotherapy | Active Comparator | After randomization, subjects will undergo radical surgery. Those who complete the radical surgery will receive adjuvant platinum-based doublet chemotherapy for 1-4 cycles after surgery, followed by 17 cycles of maintenance therapy with Toripalimab, administered every 3 weeks on first day of each cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peroperative immunotherapy | Drug | Neoadjuvant phase: Toripalimab injection [240 mg, administered on Day 1, Q3W (once every 3 weeks)] + pemetrexed injection [500 mg/m2, administered on Day 1, Q3W] + carboplatin injection (AUC=5, administered on Day 1, Q3W) or cisplatin injection (75 mg/m2, administered on Day 1, Q3W) for 3 cycles; Adjuvant phase: Toripalimab injection [240 mg, administered on Day 1, Q3W (once every 3 weeks)] + pemetrexed injection [500 mg/m2, administered on Day 1, Q3W] + carboplatin injection (AUC=5, administered on Day 1, Q3W) or cisplatin injection (75 mg/m2, administered on Day 1, Q3W) for 1 cycles; Maintenanse phase: Toripalimab injection [240 mg, administered on Day 1, Q3W (once every 3 weeks)] for 13 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year events-free survival (EFS) rate | It is defined as the percentage of the total number of individuals in the analysis dataset who, from randomization to the first recorded event, die due to disease progression leading to inoperability, distant metastatic lesions, local recurrence, or any other reason within 3 years. | From randomization up to 3 years after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
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| Neoadjuvant immunotherapy | Drug | Neoadjuvant phase: Toripalimab injection [240 mg, administered on Day 1, Q3W (once every 3 weeks)] + pemetrexed injection [500 mg/m2, administered on Day 1, Q3W] + carboplatin injection (AUC=5, administered on Day 1, Q3W) or cisplatin injection (75 mg/m2, administered on Day 1, Q3W) for 3 cycles; |
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| Adjuvant immunotherapy | Drug | Adjuvant phase: Pemetrexed injection [500 mg/m2, administered on Day 1, Q3W] + carboplatin injection (AUC=5, administered on Day 1, Q3W) or cisplatin injection (75 mg/m2, administered on Day 1, Q3W) for 1-4 cycles; Maintenanse phase: Toripalimab injection [240 mg, administered on Day 1, Q3W (once every 3 weeks)] for 17 cycles. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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