2024-514693-47-01RecruitingPhase 4
Increasing the dosing interval of osimertinib in patients with EGFR mutated locally advanced or meta-static non-small cell lung cancer - OSI-SAVE
Source: EU CTIS (euclinicaltrials.eu) · Last updated 27 Mar 2026
Brief summary (registry, in English)
The assessment of the non-inferiority of an extended dosing interval of osimertinib compared to the standard dosage.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 283 (estimated)
- First submitted
- 14 Aug 2025
- Start date
- 28 Oct 2025
- Lead sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Diseases
- Lung cancer
- EU CT number
- 2024-514693-47-01
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 283
- 17 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other
- Patients with known CNS metastases at baseline
- Usage of strong CYP3A4 inducers as described in 9.1.2
- Treatment related toxicity for which a dose reduction of osimertinib is indicated
- Patients who are either pregnant, breastfeeding or actively trying to conceive
Who the study is looking for
- Age ≥18 years
- Able to understand the written information and able to give informed consent
- Sufficient knowledge of the local language in order answer the questionnaires
- Locally advanced or metastatic NSCLC with an EGFR exon 19 deletions or exon 21 L858R muta-tions not eligible for curative intent therapy
- Treatment with first-line osimertinib 80 mg QD with or without chemotherapy for at least three months according to standard of care;
- A response on radiologic assessment (response is defined as: - complete or partial response as defined by RECIST 1.1, assessed by the treating physi-cian. - a radiological response according to the treating physician that does not meet the crite-ria for partial response according to RECIST 1.1.)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Jules Bordet | Anderlecht | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc | Bruxelles | Belgium | Recruiting |
| Grand Hopital de Charleroi | Charleroi | Belgium | Recruiting |
| Antwerp Pediatric Clinical Trial Network | Edegem | Belgium | Recruiting |
| UZ Gent | Gent | Belgium | Recruiting |
| UZ Brussel | Jette | Belgium | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
| CHU Helora | Mons | Belgium | Recruiting |
| Algemeen Ziekenhuis Delta | Roeselare | Belgium | Recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur | Yvoir | Belgium | Recruiting |
| Amsterdam UMC | Amsterdam | Netherlands | Recruiting |
| University Medical Center Groningen | Groningen | Netherlands | Recruiting |
| Leiden University Medical Center | Leiden | Netherlands | Recruiting |
| Maastricht University Medical Center | Maastricht | Netherlands | Recruiting |
| Radboud University Medical Center | Nijmegen | Netherlands | Recruiting |
| Erasmus Medisch Centrum 1 | Rotterdam | Netherlands | Recruiting |
| Universitair Medisch Centrum Utrecht | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.