RecruitingPhase 2NCT06383728

Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma

Osimertinib as Neoadjuvant Therapy in Patients With Resectable Stage II-IIIB EGFR-mutated Lung Squamous Cell Carcinoma: A Single-centre, Single-arm, Phase 2 Trial


Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Enrollment

51 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Previous trials, such as ADURA and CTONG, have demonstrated the benefits of neoadjuvant targeted therapy in patient with EGFR mutations , which can effectively reduce the extent of tumors and improve the survival outcomes. However, clinical trials of neoadjuvant targeted therapy in NSCLC have rarely enrolled patients with EGFR-mutated lung squamous cell carcinoma due to its rarity, which means that the safety and feasibility of neoadjuvant osimertinib in patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma remains controversial.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing targeted therapy drugs given before surgery (called neoadjuvant therapy) in people with a specific type of lung cancer — squamous cell carcinoma with an EGFR gene mutation — to try to shrink the tumor before it is removed. **You may be eligible if...** - You are 18 or older - You have stage II–IIIB lung squamous cell carcinoma that can be surgically removed - Your tumor has an EGFR gene mutation confirmed by genetic testing - Scans confirm the cancer has not spread to other parts of the body - You are in generally good health **You may NOT be eligible if...** - You have had another cancer in the past 5 years - You have uncontrolled infections, heart failure, autoimmune disease, or active bleeding - You have HIV or active hepatitis - You have had major surgery in the last 2 months - You are pregnant or breastfeeding 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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Interventions

DRUGOsimertinib

Patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma will receive Osimertinib ( 80mg/d, ≥9 weeks).


Locations(1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

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NCT06383728


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