NCT04216121 LAT for Oligoprogressive NSCLC Treated With First-line OSImertinib
| NCT ID | NCT04216121 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor |
| Study Type | OBSERVATIONAL |
| Enrollment | 39 participants |
| Start Date | 2021-05-10 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 39 participants in total. It began in 2021-05-10 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Male or female, ≥ 18 years of age 2. Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, with an EGFR actionable mutation receiving first-line targeted TKI therapy with osimertinib 3. Initial radiologically confirmed response (at least stable disease) to osimertinib assessed 3 months post commencing osimertinib according to RECIST criteria v1.1. 4. 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). 5. Adequate baseline organ function to allow LAT to all the OP targets. 6. Predicted life expectancy ≥ 6 months 7. Karnofsky Index ≥ 60% and ECOG 0-2 8. Provision of written informed consent 9. 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: 1. \> 3 sites of progressive disease 2. Oligoprogressive metastases not amenable to LAT 3. Radiotherapy or radiofrequency ablation near the OP lesion prior to the inclusion in the LAT-FLOSI study 4. Co-morbidities considered clinically precluding the safe use of LAT 5. Any psychological, sociological or geographical issue potentially hampering compliance with the study 6. Pregnancy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04216121 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04216121 currently recruiting?
Yes, NCT04216121 is actively recruiting participants. Contact the research team at Patrick.berkovic@uzleuven.be for enrollment information.
Where is the NCT04216121 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT04216121 clinical trial?
NCT04216121 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 39 participants.
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