Overview
To determine whether in patients with EGFR mutated advanced NSCLC and osimertinib as first-line treatment, the (repeated) use of LAT to ≤ 3 OP lesions and continuation of first-line osimertinib, improves the median progression-free survival by more than 3 months (i.e. PFS2-PFS1 = >3 months).
Description
The (repeated) use of LAT to ≤ 3 OP lesions with continuation of first-line osimertinib, is endorsed by international guidelines (NCCN, ESMO).
In this phase IIb prospective non-randomized observational trial, we want to document the benefit of LAT in this patient cohort.
Eligibility
Inclusion Criteria:
- Male or female, ≥ 18 years of age
- Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, with an EGFR actionable mutation receiving first-line targeted TKI therapy with osimertinib
- Initial radiologically confirmed response (at least stable disease) to osimertinib assessed 3 months post commencing osimertinib according to RECIST criteria v1.1.
- Confirmed OPD defined as ≤ 3 intra- and extracranial sites of progressive disease. OP may be defined as progression of an individual metastasis according to RECIST or on 2 consecutive imaging studies at least 2 months apart with a minimum of 5mm increase in size from baseline or an unambiguous development of a new metastatic lesion with a grand total of 3 lesions. All sites must be visible, imaging defined targets, not previously treated with radiation or radiofrequency and suitable for treatment with LAT as determined by the local multi-disciplinary team (MDT).
- Adequate baseline organ function to allow LAT to all the OP targets.
- Predicted life expectancy ≥ 6 months
- Karnofsky Index ≥ 60% and ECOG 0-2
- Provision of written informed consent
- Female participants must be surgically sterile or postmenopausal if SBRT is planned to the abdominal area or must agree to use effective contraception during the period of therapy.
Exclusion Criteria:
- > 3 sites of progressive disease
- Oligoprogressive metastases not amenable to LAT
- Radiotherapy or radiofrequency ablation near the OP lesion prior to the inclusion in the LAT-FLOSI study
- Co-morbidities considered clinically precluding the safe use of LAT
- Any psychological, sociological or geographical issue potentially hampering compliance with the study
- Pregnancy