Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Location status: Recruiting
NCT Number: NCT07554846
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 sensitive mutations. This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1030.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 3
Shanghai, 200032, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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: 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.
Time frame: From randomization up to 3 years after randomization
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.
Fudan University
Other
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)
Acronym: ECTOP-1030
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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