Increasing the dosing interval of osimertinib in patients with EGFR mutated locally advanced or meta-static non-small cell lung cancer - OSI-SAVE
Key facts
- Where
- Anderlecht, Bruxelles, Charleroi, Edegem, Gent, Jette, Leuven, Mons, Roeselare és Yvoir, BelgiumSee the 10 sites
- Phase
- 4. fázis
Where in Belgium
- Institut Jules BordetAnderlecht, BelgiumTaking people
- Cliniques Universitaires Saint-LucBruxelles, BelgiumTaking people
- Grand Hopital de CharleroiCharleroi, BelgiumTaking people
- Antwerp Pediatric Clinical Trial NetworkEdegem, BelgiumTaking people
- UZ GentGent, BelgiumTaking people
- UZ BrusselJette, BelgiumTaking people
- UZ LeuvenLeuven, BelgiumTaking people
- CHU HeloraMons, BelgiumTaking people
- Algemeen Ziekenhuis DeltaRoeselare, BelgiumTaking people
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-NamurYvoir, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Trial code
- EU 2024-514693-47-01
- Record updated
- 2026. március 27.
- Original description
The assessment of the non-inferiority of an extended dosing interval of osimertinib compared to the standard dosage.Read full original descriptionShow less
The assessment of the non-inferiority of an extended dosing interval of osimertinib compared to the standard dosage.
Inclusion: 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.).
Exclusion: 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.