Lung Cancer (NSCLC)Phase 2NCT07379476
Local Ablative Therapy to Oligoresidual Metastasis in EGFR Mutated Non-small Cell Lung Cancer
A Phase 2 study testing Local ablative therapy and Osimertinib alone in people with Lung Cancer (NSCLC), run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Local ablative therapy and Osimertinib alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Feb 2026to 3 Mar 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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.
- Mixed SCLC and NSCLC histology
- Positive pregnancy test
- Contraindication to radiotherapy
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
Molly SC LI, MBBS, MRCP, 3505 1042, molly@clo.cuhk.edu.hk
Molly SC LI, MBBS, MRCP
About this study
Official title: ATOM2: A Randomized Phase II Trial on Ablative Therapy to Oligoresidual Metastasis in EGFR Mutated Non-small Cell Lung Cancer After Osimertinib Treatment
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.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Local ablative therapy, Osimertinib alone
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local ablative therapyRadiation
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.
Osimertinib aloneDrug
Continue osimertinib as per standard of care (40mg or 80mg daily)
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy arm | Experimental | * Continue osimertinib as per standard of care (40mg or 80mg daily).
* Undergo radiotherapy to 1-3 disease sites as determined by the investigator. Receives: Radiation: Local ablative therapy |
| Control arm | Active comparator | Continue osimertinib as per standard of care (40mg or 80mg daily) Receives: Drug: Osimertinib alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
18 month progression-free survival rate (PFS) in per-protocol population as determined by investigator.
Measured: up to 2 years
Secondary outcomes (4)
Overall survival (OS)
Measured: 2 years
Safety and tolerability reflected by number of participants with treatment related adverse events as assessed by CTCAE v5.0, number of participants with SAE
Measured: 2 years
Time to treatment failure (TTF), defined as the time period between osimertinib initiation and cessation or death
Measured: 2 years
Site of tumour progression at disease progression
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start11 Feb 2026
- Primary completion3 Mar 2029 (estimated)
- Study completion3 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Molly SC Li, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379476
- Sponsor's protocol ID
- LUN126
- Status last verified
- Feb 2026
- First submitted
- 17 Dec 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATOM2: A Randomized Phase II Trial on Ablative Therapy to Oligoresidual Metastasis in EGFR Mutated Non-small Cell Lung Cancer After Osimertinib Treatment
- ClinicalTrials.gov ID
- NCT07379476
- Acronym / sponsor ID
- LUN126
- Conditions
- Lung Cancer (NSCLC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 3 Mar 2029 (estimated)
- Study completion
- 3 Mar 2030 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy arm | Experimental | Radiation: Local ablative therapy* Continue osimertinib as per standard of care (40mg or 80mg daily). * Undergo radiotherapy to 1-3 disease sites as determined by the investigator. |
| Control arm | Active comparator | Drug: Osimertinib aloneContinue osimertinib as per standard of care (40mg or 80mg daily) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
- Mixed SCLC and NSCLC histology
- Positive pregnancy test
- Contraindication to radiotherapy
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local ablative therapyLocal 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. | Radiation | Radiotherapy arm |
| Osimertinib aloneContinue osimertinib as per standard of care (40mg or 80mg daily) | Drug | Control arm |
Primary outcome
18 month progression-free survival rate (PFS) in per-protocol population as determined by investigator.
Time frame: up to 2 years
4 secondary outcomes
Overall survival (OS)
Time frame: 2 years
Safety and tolerability reflected by number of participants with treatment related adverse events as assessed by CTCAE v5.0, number of participants with SAE
Time frame: 2 years
Time to treatment failure (TTF), defined as the time period between osimertinib initiation and cessation or death
Time frame: 2 years
Site of tumour progression at disease progression
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Local ablative therapy and Osimertinib alone in people with Lung Cancer (NSCLC), run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Molly SC LI, MBBS, MRCP (3505 1042, molly@clo.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18 month progression-free survival rate (PFS) in per-protocol population as determined by investigator. (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.