RecruitingPhase 2NCT05536505

Adjuvant Treatment Based on MRD for EGFR Mutant NSCLC

Adjuvant Treatment Based on Minimal Residual Disease for Resectable Non-squamous Non-Small-Cell-Lung-Cancer With EGFR Mutations


Sponsor

Guangdong Association of Clinical Trials

Enrollment

180 participants

Start Date

Sep 13, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

A prospective, multicenter clinical study designed to explore the efficacy of postoperative adjuvant EGFR-TKIs therapy based on MRD status in patients with stage IB-IIIB EGFR-mutant non-squamous non-small cell lung cancer (non-squamous NSCLC). Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and median disease-free survival (mDFS).


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving targeted therapy (a drug called osimertinib or a similar EGFR inhibitor) after lung cancer surgery can be guided by a blood test that detects residual cancer DNA. Rather than giving all patients the same treatment, doctors would use this sensitive test to determine who still has cancer cells remaining after surgery and who actually needs additional treatment. **You may be eligible if:** - You are 18–79 years old - You have non-small cell lung cancer (NSCLC) with a specific EGFR gene mutation (exon 19 deletion, L858R, L861Q, or G719X) - Your lung cancer has been completely removed by surgery (stage IB–IIIB) - Your general health is good (ECOG score 0–1) - Your blood cell counts and organ function meet the required levels **You may NOT be eligible if:** - Your cancer has spread beyond what surgery can address - You have had prior EGFR-targeted drug treatment - You have serious liver, kidney, or heart problems - 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

GENETICAdjuvant treatment for MRD positivity

The MRD positive group would receive icotinib as adjuvant treatment. When the peripheral blood MRD turned negative, the subjects entered the drug withdrawal observation period. When the MRD turned positive again, the subjects resumed icotinib treatment. If EGFR T790M mutation was found, researchers would resume medication and choose osimertinib therapy.


Locations(16)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Chongqing University Three Gorges Hospital

Chongqing, China

The First People's Hospital of Foshan

Foshan, China

Fujian Medical University Union Hospital

Fuzhou, China

Affiliated Cancer Hospital of Guangzhou Medical University

Guangzhou, China

Nanfang Hospital Southern Medical University

Guangzhou, China

Guangdong Provincial People's Hospital

Guanzhou, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

The First Affiliated Hospital of USTC Anhui Provincial Hospital

Hefei, China

The Affiliated Hospital of Inner Mongolia Hospital

Hohhot, China

The Affiliated Hospital of Qingdao University

Qingdao, China

Zhongshan Hospital Fudan University

Shanghai, China

Shenzhen People's Hospital

Shenzhen, China

Tongji Hospital Tongji College of HUST

Wuhan, China

The First Affiliated Hospital of Xiamen University

Xiamen, China

Zhongshan City People's Hospital

Zhongshan, China

View Full Details on ClinicalTrials.gov

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NCT05536505


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