Local Ablative Therapy to Oligoresidual Metastasis in EGFR Mutated Non-small Cell Lung Cancer

Sponsor
Chinese University of Hong Kong
Study ID
NCT07379476
Phase
PHASE2
Status
Recruiting
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Conditions

  • Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Local ablative therapy — RADIATION
    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 alone — DRUG
    Continue osimertinib as per standard of care (40mg or 80mg daily)

Study Details

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.

Key Dates

Start date
Feb 11, 2026
Status verified
Feb 2026
Primary completion
Mar 3, 2029
Completion
Mar 3, 2030

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Radiotherapy arm
    * Continue osimertinib as per standard of care (40mg or 80mg daily). * Undergo radiotherapy to 1-3 disease sites as determined by the investigator.
  • Active Comparator: Control arm
    Continue osimertinib as per standard of care (40mg or 80mg daily)

Primary Outcome Measure

18 month progression-free survival rate (PFS) in per-protocol population as determined by investigator. [ Time Frame: up to 2 years ]

Central Contacts

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