RecruitingPhase 2NCT07379476

Local Ablative Therapy to Oligoresidual Metastasis in EGFR Mutated Non-small Cell Lung Cancer

ATOM2: A Randomized Phase II Trial on Ablative Therapy to Oligoresidual Metastasis in EGFR Mutated Non-small Cell Lung Cancer After Osimertinib Treatment


Sponsor

Chinese University of Hong Kong

Enrollment

64 participants

Start Date

Feb 11, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, multicentre, randomized phase II clinical trial. Patients with stage IV (AJCC 9th edition) non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion or exon 21 L858R mutation, who had less than or equal to 3 active oligoresidual cancer sites amenable to local ablative therapy (LAT) (as determined by physician) after 3-6 months of firstline osimertinib treatment, are eligible. Subjects will be randomized 1:1 to osimertinib with or without LAT.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a focused local treatment (such as radiation or ablation) to the small number of remaining disease sites after the targeted therapy osimertinib improves outcomes in patients with EGFR-mutated, stage IV non-small cell lung cancer. **You may be eligible if...** - You are 18 or older with confirmed non-small cell lung cancer and an EGFR exon 19 deletion or exon 21 L858R mutation - You have stage IV disease and are currently being treated with osimertinib (a targeted lung cancer drug) - After 12–24 weeks of osimertinib, your cancer has not progressed and you have 3 or fewer active disease sites that can receive local treatment - You have had at least one brain scan to check for brain involvement **You may NOT be eligible if...** - Your disease has progressed on osimertinib - You have more than 3 active disease sites - Your blood counts or organ function are below acceptable levels 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

RADIATIONLocal ablative therapy

Local ablative therapy (LAT) will be given in the form of stereotactic body radiotherapy (SBRT) or hypofractionated radiotherapy. LAT should be started within 90 days from the screening PET-CT scan.

DRUGOsimertinib alone

Continue osimertinib as per standard of care (40mg or 80mg daily)


Locations(1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

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NCT07379476


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