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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

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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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (17)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Institut Jules BordetAnderlechtBelgiumRecruiting
Cliniques Universitaires Saint-LucBruxellesBelgiumRecruiting
Grand Hopital de CharleroiCharleroiBelgiumRecruiting
Antwerp Pediatric Clinical Trial NetworkEdegemBelgiumRecruiting
UZ GentGentBelgiumRecruiting
UZ BrusselJetteBelgiumRecruiting
UZ LeuvenLeuvenBelgiumRecruiting
CHU HeloraMonsBelgiumRecruiting
Algemeen Ziekenhuis DeltaRoeselareBelgiumRecruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-NamurYvoirBelgiumRecruiting
Amsterdam UMCAmsterdamNetherlandsRecruiting
University Medical Center GroningenGroningenNetherlandsRecruiting
Leiden University Medical CenterLeidenNetherlandsRecruiting
Maastricht University Medical CenterMaastrichtNetherlandsRecruiting
Radboud University Medical CenterNijmegenNetherlandsRecruiting
Erasmus Medisch Centrum 1RotterdamNetherlandsRecruiting
Universitair Medisch Centrum UtrechtUtrechtNetherlandsRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.