Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor ReceptorLAT-FLOSINCT04216121
LAT for Oligoprogressive NSCLC Treated With First-line OSImertinib
An observational study of Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
- What is being tested?
- Local ablative therapy
- Type of treatment
- Surgery or procedure
- How many people
- 39 participants
- Where
- 1 siteBelgium
- Study dates
- 10 May 2021to Oct 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, with an EGFR actionable mutation receiving first-line targeted TKI therapy with osimertinib. Confirmed oligoprogressive disease defined as ≤ 3 intra- and extracranial sites of progressive disease
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- > 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZLeuven
Leuven, 3000
Patrick Berkovic, MD
Els Wauters, MD, PhD
About this study
Official title: Local AblativeTherapy for Oligoprogressive Non-Small-Cell Lung Cancer Treated With First-line OSImertinib
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).
Read the detailed 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.
- Being tested
- Local ablative therapy
- Keywords
- First line osimertinib, Local ablative therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local ablative therapyRadiation
Also called SBRT
Stereotactic body radiotherapy
Local ablative therapyProcedure or surgery
Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS 2
Progression Free Survival 2
Measured: Time from start of osimertinib until first PD after LAT or death whichever comes first, up to 3 year after LAT
Secondary outcomes (4)
Time to next line systemic therapy
Measured: Time from LAT until initiation of next line systemic therapy or death whichever comes first, up to 3 years after LAT
Patterns of disease progression
Patterns of disease progression after local ablative therapy (LAT) identified on sequential CT scans taken at 3 monthly intervals to document the natual history of the disease after LAT
Measured: Time from LAT until disease progression or death whichever comes first, up to 3 years after LAT
Radiotherapy induced toxicity
Acute and late radiotherapy induced toxicities assessed using the CTCAE v4.0. and the RTOG/EORTC late morbidity score. Acute events are defined as ≤ 90 days post SBRT and late events > 90 days.
Measured: Change in toxicity measured from baseline up to 3 years after radiotherapy
Quality of life
Quality of life is measured by the EORTC QLQ-LC13 questionnaire comprised both of multi-item and single-item measures of lung cancer-associated symptoms (i.e. coughing, haemoptysis, dyspnoea and pain) and side-effects from conventional chemo- and radiotherapy (i.e. hair loss, neuropathy, sore mouth and dysphagia).
Measured: Change in quality of life measured from baseline up to 3 years after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start10 May 2021
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor ReceptorStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216121
- Sponsor's protocol ID
- S63270
- Acronym
- LAT-FLOSI
- Status last verified
- Jun 2024
- First submitted
- 9 Dec 2019
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local AblativeTherapy for Oligoprogressive Non-Small-Cell Lung Cancer Treated With First-line OSImertinib
- ClinicalTrials.gov ID
- NCT04216121
- Acronym / sponsor ID
- LAT-FLOSI / S63270
- Keywords
- First line osimertinib, Local ablative therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, with an EGFR actionable mutation receiving first-line targeted TKI therapy with osimertinib. Confirmed oligoprogressive disease defined as ≤ 3 intra- and extracranial sites of progressive disease
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- > 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local ablative therapyAlso: SBRTStereotactic body radiotherapy | Radiation | – |
| Local ablative therapySurgery | Procedure or surgery | – |
Primary outcome
PFS 2
Time frame: Time from start of osimertinib until first PD after LAT or death whichever comes first, up to 3 year after LAT
Progression Free Survival 2
4 secondary outcomes
Time to next line systemic therapy
Time frame: Time from LAT until initiation of next line systemic therapy or death whichever comes first, up to 3 years after LAT
Patterns of disease progression
Time frame: Time from LAT until disease progression or death whichever comes first, up to 3 years after LAT
Radiotherapy induced toxicity
Time frame: Change in toxicity measured from baseline up to 3 years after radiotherapy
Quality of life
Time frame: Change in quality of life measured from baseline up to 3 years after radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Berkovic, MD (+32-16-34-51-15, Patrick.berkovic@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS 2 (time frame: Time from start of osimertinib until first PD after LAT or death whichever comes first, up to 3 year after LAT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.