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LAT for Oligoprogressive NSCLC Treated With First-line OSImertinib (LAT-FLOSI)

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ClinicalTrials.gov Identifier: NCT04216121
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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).

Condition or disease Intervention/treatment
Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor Radiation: Local ablative therapy Procedure: Local ablative therapy

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Local AblativeTherapy for Oligoprogressive Non-Small-Cell Lung Cancer Treated With First-line OSImertinib
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Osimertinib


Intervention Details:
  • Radiation: Local ablative therapy
    Stereotactic body radiotherapy
    Other Name: SBRT
  • Procedure: Local ablative therapy
    Surgery


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
  2. Patterns of disease progression [ Time Frame: Time from LAT until disease progression or death whichever comes first, up to 3 years after LAT ]
    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

  3. Radiotherapy induced toxicity [ Time Frame: Change in toxicity measured from baseline up to 3 years after radiotherapy ]
    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.

  4. Quality of life [ Time Frame: Change in quality of life measured from baseline up to 3 years after radiotherapy ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216121


Contacts
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Contact: Patrick Berkovic, MD +32-16-34-51-15 Patrick.berkovic@uzleuven.be
Contact: Els Wauters, MD, PhD +32 16-34-09-42 els.wauters@uzleuven.be

Locations
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Belgium
UZLeuven Recruiting
Leuven, Belgium, 3000
Principal Investigator: Patrick Berkovic, MD         
Sub-Investigator: Els Wauters, MD, PhD         
Sub-Investigator: Johan Vansteenkiste, MD, PhD         
Sub-Investigator: Maarten Lambrecht, MD, PhD         
Sub-Investigator: Christel Oyen, RN         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04216121    
Other Study ID Numbers: S63270
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
First line osimertinib
Local ablative therapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms