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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
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.
Continue osimertinib as per standard of care (40mg or 80mg daily)
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
RECRUITING18 month progression-free survival rate (PFS) in per-protocol population as determined by investigator.
Time frame: up to 2 years
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
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