Actively Recruiting

Age: 18Years +
All Genders
NCT04216121

LAT for Oligoprogressive NSCLC Treated With First-line OSImertinib

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01

39

Participants Needed

1

Research Sites

229 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

LAT for Oligoprogressive NSCLC Treated With First-line OSImertinib

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, 18 years of age or older
  • Histological diagnosis of advanced NSCLC with an EGFR actionable mutation
  • Receiving first-line targeted TKI therapy with osimertinib
  • Radiologically confirmed response (at least stable disease) to osimertinib assessed 3 months after starting treatment
  • Confirmed oligoprogression with 3 or fewer intra- or extracranial progressive disease sites eligible for LAT
  • All progressive sites visible and suitable for LAT, not previously treated with radiation or radiofrequency
  • Adequate baseline organ function to allow LAT
  • Predicted life expectancy of 6 months or more
  • Karnofsky Performance Status of 60% or higher and ECOG performance status 0-2
  • Written informed consent provided
  • If SBRT to abdominal area is planned, female participants must be surgically sterile, postmenopausal, or agree to use effective contraception during therapy
Not Eligible

You will not qualify if you...

  • More than 3 sites of progressive disease
  • Progressive metastases not suitable for LAT
  • Prior radiotherapy or radiofrequency ablation near the progressive lesion before study inclusion
  • Co-morbidities that prevent safe use of LAT
  • Psychological, sociological, or geographical issues that could impair study compliance
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UZLeuven

Leuven, Belgium, 3000

Actively Recruiting

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Research Team

P

Patrick Berkovic, MD

CONTACT

E

Els Wauters, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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