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New combo attack on lung cancer: drug plus local therapy may delay progression
NCT ID NCT07379476
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a local treatment (like radiation or ablation) to the standard drug osimertinib can better control advanced EGFR-mutated lung cancer. About 64 adults with stable disease after 3-6 months on osimertinib and up to 3 remaining active spots will be randomly assigned to continue the drug alone or add local therapy. The goal is to see if the combination improves the chance of staying progression-free at 18 months.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Clinical Oncology, Prince of Wales Hospital
RECRUITINGHong Kong, Hong Kong
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