RecruitingPhase 2NCT06269211

Neoadjuvant Toripalimab for Clinically Stage II-IIIB Resectable Non-small Cell Lung Cancer with EGFR Mutation and PD-L1 Positive Expression

Neoadjuvant Toripalimab for Clinically Stage II-IIIB Resectable Non-small Cell Lung Cancer with EGFR Mutation and PD-L1 Positive Expression: a Prospective, Open-label, Multicenter, Single-arm Phase II Clinical Study

Sponsor

Ruijin Hospital

Enrollment

29 participants

Start Date

Apr 20, 2024

Study Type

INTERVENTIONAL

Conditions

Carcinoma, Non-Small Cell Lung

Summary

The study is a prospective, open label, multicenter, single arm Phase II clinical trial, aiming to explore the use of neoadjuvant Toripalimab for clinically stage II-IIIB NSCLC patients with EGFR mutations and PD-L1 positive expression, providing a novel perspective for further improving the prognosis of NSCLC patients. This study will provide valuable information for further clinical trials of neoadjuvant Toripalimab and other immune checkpoint inhibitors in NSCLC patients with EGFR mutations and PD-L1 positive expression.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving an immunotherapy drug called toripalimab before surgery (neoadjuvant treatment) can improve outcomes in patients with non-small cell lung cancer that has an EGFR mutation and also shows signs of immune activity (PD-L1 positive). **You may be eligible if...** - You are 18 or older - You have been diagnosed with non-squamous non-small cell lung cancer, Stage II–IIIB, that can be surgically removed - Your tumor has a confirmed EGFR mutation - Your tumor tests positive for PD-L1 (a protein that indicates potential immune response to therapy) - A biopsy has confirmed your diagnosis **You may NOT be eligible if...** - Your tumor does not have an EGFR mutation or does not express PD-L1 - Your cancer is not operable - You have serious autoimmune conditions or organ dysfunction - You are pregnant Talk to your doctor to see if this trial is right for you.

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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