LAT for Oligoprogressive NSCLC Treated With First-line OSImertinib

NCT ID: NCT04216121

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 39 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-10
• Study Completion Date: 2025-10-31

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).

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Local ablative therapy

Stereotactic body radiotherapy

Intervention Type: RADIATION

Local ablative therapy

Surgery

Intervention Type: PROCEDURE

Other Intervention Names

SBRT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZLeuven

Leuven, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Patrick Berkovic, MD

Role: CONTACT

Patrick.berkovic@uzleuven.be

+32-16-34-51-15

Els Wauters, MD, PhD

Role: CONTACT

els.wauters@uzleuven.be

+32 16-34-09-42

Other Identifiers

S63270

Identifier Type: -

Identifier Source: org_study_id