NCT06572722

Perioperative Immunotherapy for NSCLC (ECTOP-1030)

Perioperative Immunotherapy for Early-stage Non-small-cell Lung Cancer: a Randomised, Multicentre, Open-label, Phase 2 Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This trial is a randomized, multicenter, open label phase II clinical study. The main objective is to evaluate the efficacy of three perioperative immunotherapy modalities (atezolizumab adjuvant therapy, nivolumab neoadjuvant therapy, pembrolizumab neoadjuvant+adjuvant therapy) in early-stage resectable NSCLC patients. The enrolled patients are randomly assigned in a 1:1:1 ratio to receive relevant treatment in the three perioperative immunotherapy groups mentioned above, and undergoing short-term pathological efficacy evaluation and long-term prognosis follow-up after surgery.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab	atezolizumab adjuvant therapy
DRUG	Nivolumab	nivolumab neoadjuvant therapy
DRUG	Pembrolizumab	pembrolizumab neoadjuvant+adjuvant therapy

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-09-01
• Completion: 2029-09-01
• First posted: 2024-08-27
• Last updated: 2024-08-27