Actively Recruiting
Local Ablative Therapy to Oligoresidual Metastasis in EGFR Mutated Non-small Cell Lung Cancer
Led by Chinese University of Hong Kong · Updated on 2026-02-12
64
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Local Ablative Therapy to Oligoresidual Metastasis in EGFR Mutated Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older and able to understand and give written informed consent
- Pathologically confirmed non-small cell lung cancer
- Positive for EGFR exon 19 deletion or exon 21 L858R mutation by tissue or plasma testing
- Stage IV disease
- Receiving first-line osimertinib monotherapy for stage IV disease
- PET-CT scan 12-24 weeks after starting osimertinib showing no disease progression and 3 or fewer active disease sites suitable for local ablative therapy
- At least one brain imaging (CT or MRI with contrast) done at diagnosis or during osimertinib treatment before randomization
- Patients with asymptomatic CNS metastases eligible
- Patients with prior palliative radiotherapy eligible
- ECOG performance status 0-1
- Adequate blood counts: haemoglobin ≥9.0 g/dL, absolute neutrophil count ≥1.0 x 10^9/L, platelet count ≥100 x 10^9/L
- Adequate liver function: bilirubin ≤1.5 x upper limit of normal, AST/ALT ≤2.5 x upper limit of normal
- Adequate kidney function: creatinine clearance ≥30 ml/min (Cockcroft-Gault equation)
- Willing and able to follow protocol requirements
You will not qualify if you...
- Previous or concurrent malignancy within 5 years except treated localized non-melanoma skin cancer or cervical cancer in situ
- Mixed small cell lung cancer and non-small cell lung cancer histology
- Positive pregnancy test
- Contraindication to radiotherapy
- Serious medical, psychiatric, psychological, or familial conditions that may interfere with staging, treatment, follow-up, compliance, or increase risk of treatment complications
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
M
Molly SC LI, MBBS, MRCP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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