LAT for Oligoprogressive NSCLC Treated With First-line OSImertinib

NCT04216121 | Recruiting

• 1 other identifier: S63270
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor

Keywords

First line osimertinib; Local ablative therapy

Outcome Measures

Primary Outcomes (1)

• PFS 2

  Progression Free Survival 2

  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

  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 from LAT until disease progression or death whichever comes first, up to 3 years after LAT

• Radiotherapy induced toxicity

  Change in toxicity measured from baseline up to 3 years after radiotherapy

• Quality of life

  Change in quality of life measured from baseline up to 3 years after radiotherapy

Interventions

Local ablative therapy RADIATION

Stereotactic body radiotherapy

Also known as: SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• \> 3 sites of progressive disease
• Oligoprogressive metastases not amenable to LAT
• Co-morbidities considered clinically precluding the safe use of LAT
• Any psychological, sociological or geographical issue potentially hampering compliance with the study
• Pregnancy

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZLeuven

Leuven, 3000, Belgium

RECRUITING

Central Study Contacts

Patrick Berkovic, MD

CONTACT

+32-16-34-51-15; Patrick.berkovic@uzleuven.be

Els Wauters, MD, PhD

CONTACT

+32 16-34-09-42; els.wauters@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: January 2, 2020
• Study Start: May 10, 2021
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

BE (1)