RecruitingPhase 4NCT06561620

Befotertinib Adjuvant Therapy in Stage IA2-IB NSCLC Patients

A Prospective Study of Befotertinib Adjuvant Therapy in Patients With Postoperative MRD-positive Non-small Cell Lung Cancer in Stage IA2-IB With High Risk Factors


Sponsor

Fudan University

Enrollment

592 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate 3-year disease-free survival after complete resection in patients with MRD-positive EGFR-sensitive mutations in Stage IA2-IB NSCLC treated with adjuvant befortinib and under routine observation (3y-DFS).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests befotertinib — a targeted oral drug that blocks the EGFR mutation — as preventive treatment after surgery for patients with early-stage lung cancer (stage IA2–IB) who have an EGFR mutation and evidence of minimal residual disease detected in the blood. **You may be eligible if...** - You are aged 18–75 and had surgery for early-stage lung adenocarcinoma with clear margins - Your tumor tested positive for a sensitive EGFR mutation - A blood test after surgery showed residual cancer markers (MRD positive) - Your tumor is 1–4 cm and you have at least 2 high-risk features (e.g., blood vessel invasion, poor differentiation) **You may NOT be eligible if...** - You have received any treatment before surgery - You have had another cancer within the past 2 years - You have a history of interstitial lung disease - 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

DRUGBefotertinib

Befotertinib is a novel, selective oral third-generation epidermal growth factor receptor tyrosine-kinase inhibitor.


Locations(1)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06561620