Using local therapy to treat progressive lung cancer while on osimertinib

Local AblativeTherapy for Oligoprogressive Non-Small-Cell Lung Cancer Treated With First-line OSImertinib

This study is testing if adding a local treatment to the standard drug osimertinib can help people with advanced lung cancer live longer without their disease getting worse.

Quick facts

• Study type: Observational
• Enrollment: 39 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universitaire Ziekenhuizen KU Leuven (other)
• Drugs / interventions: osimertinib, radiation
• Locations: 1 site (Leuven)
• Trial ID: NCT04216121 on ClinicalTrials.gov

What this trial studies

This observational trial aims to evaluate the effectiveness of local ablative therapy (LAT) in patients with advanced non-small cell lung cancer (NSCLC) who have an EGFR mutation and are receiving osimertinib as their first-line treatment. The study will focus on patients with up to three sites of oligoprogressive disease, assessing whether the addition of LAT can improve progression-free survival by more than three months. The trial is designed as a phase IIb prospective non-randomized observational study, following international guidelines for treatment. Participants will be monitored for their response to the combined treatment approach over time.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced NSCLC and an EGFR mutation who are experiencing oligoprogressive disease while on osimertinib.

Not a fit: Patients who have more than three sites of progressive disease or those who are not suitable for local ablative therapy will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly extend the time patients with oligoprogressive NSCLC can live without disease progression.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this treatment strategy.

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

Where this trial is running

Leuven

• UZLeuven — Leuven, Belgium (RECRUITING)

Study contacts

• Study coordinator: Patrick Berkovic, MD

Conditions: Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor, First line osimertinib, Local ablative therapy