NCT07379476RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 17 Dec 2025
- Start date
- 11 Feb 2026
- Primary completion date
- 3 Mar 2029
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Lung cancer
- NCT number
- NCT07379476
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 64
- From 11 Feb 2026 to the primary completion date, 3 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or concomitant malignancy within 5 years prior registration with the exception of adequately treated localized non-melanoma skin cancer or cervical cancer in situ.
- Contraindication to radiotherapy
Other illness
- Any serious underlying medical, psychiatric, psychological, familial condition that in the judgement of the investigator, that may interfere with planned staging, treatment and follow up, affect patient compliance, or place the patient at high risk from treatment related complications
Other
- Mixed SCLC and NSCLC histology
- Positive pregnancy test
Who the study is looking for
- 18 years of age or older and able to understand and give written informed consent
- Pathologically proven non-small cell lung cancer
- Positive for EGFR exon 19 deletion or EGFR exon 21 L858R mutation (either by tissue or plasma testing)
- Stage IV disease
- Receive first line osimertinib monotherapy for stage IV disease
- Undergo a PET-CT scan after 12-24 weeks of initiation of osimertinib treatment, with no evidence of disease progression, and less than or equal to 3 active disease sites (including primary tumour) amenable to local ablative therapy, as determined by investigator
- At least one brain imaging (CT Brain or MRI Brain with contrast, preferably MRI Brain), either at time of diagnosis or while on osimertinib treatment but before randomization, to document CNS status for stratification. Patients with asymptomatic CNS metastases are eligible. For patients with brain metastases diagnosed at baseline, follow up brain imaging is recommended before randomization.
- Patients with history of palliative radiotherapy are eligible
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate haematological values: haemoglobin ≥9.0g/dL, absolute neutreophil count ≥1.0 x 109/L, platelet count ≥100 x 109/L
- Adequate hepatic function: bilirubin ≤1.5 x ULN, AST/ALT ≤2.5 x ULN
- Adequate renal function: creatinine clearance ≥30ml/min, according to the formula of Cockcroft-Gault equation
- Willing and able to comply with the requirements and restrictions in this protocol
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Clinical Oncology, Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.