RecruitingPhase 3NCT07554846

Comparison of Perioperative Immunotherapy, Adjuvant Immunotherapy or Neoadjuvant Immunotherapy for Resectable Stage II-IIIA NSCLC

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)


Sponsor

Fudan University

Enrollment

759 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

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 sensitive mutations. This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1030.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Adjuvant immunotherapy, a drug called Neoadjuvant immunotherapy, and others for people with resectable stage ii-iiia nsclc. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPeroperative 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.

DRUGNeoadjuvant 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;

DRUGAdjuvant 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

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NCT07554846