RecruitingPhase 3NCT04841811

MRD Guiding Treatment After Almonertinib Induction Therapy for EGFRm+ Stage III NSCLC in the MDT Diagnostic Model.

Effectiveness and Safety of Dynamic MRD Guiding Treatment After Aumolertinib Induction Therapy of EGFR-mutation-positive Unresectable Stage III Non-Small Cell Lung Cancer in the MDT Diagnostic Model: an Open-label, Multicenter, Randomized, Phase III Study


Sponsor

Guangdong Association of Clinical Trials

Enrollment

192 participants

Start Date

Jun 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, multi-center, randomized, phase III study. It is aimed to firstly evaluate the effectiveness and safety of almonertinib induction therapy in EGFR-mutated patients with unresectable stage III non-small cell lung cancer, and to evaluate the effectiveness and safety of dynamic MRD guided maintenance therapy with almonertinib after induction therapy with almonertinib and local therapy (radical surgery or radiotherapy) evaluated by MDT diagnostic model. The study includes a screening period (not more than 28 days after the subject with signed informed consent before first medication), treatment period (including induction therapy with almonertinib\\ radical therapy under MDT model\\ consolidation therapy with almonertinib) and follow-up period.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a sensitive blood test (called MRD — measurable residual disease) to guide treatment decisions after initial therapy with almonertinib (a targeted drug) can improve outcomes for people with unresectable stage III non-small cell lung cancer that carries a specific mutation called EGFR. **You may be eligible if:** - You are 18–70 years old - You have stage III non-small cell lung cancer that cannot be surgically removed - Your tumor has an EGFR mutation (specifically exon 19 deletion or L858R) - You are in generally good health (ECOG 0–1) with no signs of disease worsening recently **You may NOT be eligible if:** - You have previously had lung surgery, chemotherapy, immunotherapy, or targeted therapy for lung cancer - You have another active cancer - You have serious heart rhythm problems, severe lung scarring, or uncontrolled infections - You are pregnant or breastfeeding - You have a history of severe eye disease 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

DRUGAlmonertinib

ctDNA dynamic monitoring guided the Almonertinib treatment group after redical surgery orradiotherapy


Locations(1)

Guangdong Lung cancer institute

Guangzhou, Guangdong, China

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NCT04841811


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