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Comparison of Perioperative Immunotherapy, Adjuvant Immunotherapy or Neoadjuvant Immunotherapy for Resectable Stage II-IIIA NSCLC
Sponsor: Fudan University
Summary
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.
Official title: A Randomized, Open-label, Multicenter Phase III Clinical Trial Comparing Perioperative Immunotherapy to Adjuvant Immunotherapy or Neoadjuvant Immunotherapy With Toripalimab in Resectable Stage II-IIIA Non-small Cell Lung Cancer (ECTOP-1030)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
759
Start Date
2026-05-01
Completion Date
2032-05-01
Last Updated
2026-04-28
Healthy Volunteers
No
Conditions
Interventions
Peroperative immunotherapy
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.
Neoadjuvant immunotherapy
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 immunotherapy
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.
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, China