Clinical trial • Oncology
Osimertinib for Non-small cell lung cancer (EGFR-mutated, locally advanced or metastatic)
Clinical trial of Osimertinib for Non-small cell lung cancer (EGFR-mutated, locally advanced or metastatic).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer (EGFR-mutated, locally advanced or metastatic)
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 14-08-2025
- First CTIS Authorization Date
- 28-10-2025
Trial design
osimertinib 80 mg once daily (QD) compared with osimertinib 80 mg every other day (QOD)-controlled trial across 17 sites in Netherlands, Belgium.
- Comparator
- osimertinib 80 mg once daily (QD) compared with osimertinib 80 mg every other day (QOD)
- Biomarker Stratified
- True - EGFR mutation (exon 19 deletions or exon 21 L858R)
- Target Sample Size
- 283
Eligibility
Recruits 283 Vulnerable population not selected. Inclusion requires the ability to understand written information and to give informed consent; sufficient knowledge of the local language is required; only adults (Age ≥18 years) are eligible..
- Pregnancy Exclusion
- Patients who are either pregnant, breastfeeding or actively trying to conceive
- Vulnerable Population
- Vulnerable population not selected. Inclusion requires the ability to understand written information and to give informed consent; sufficient knowledge of the local language is required; only adults (Age ≥18 years) are eligible.
Inclusion criteria
- {"criterion_text":"- Age ≥18 years\n- Able to understand the written information and able to give informed consent\n- Sufficient knowledge of the local language in order answer the questionnaires\n- Locally advanced or metastatic NSCLC with an EGFR exon 19 deletions or exon 21 L858R muta-tions not eligible for curative intent therapy\n- Treatment with first-line osimertinib 80 mg QD with or without chemotherapy for at least three months according to standard of care;\n- 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 criteria
- {"criterion_text":"- Patients with known CNS metastases at baseline\n- Usage of strong CYP3A4 inducers as described in 9.1.2\n- Treatment related toxicity for which a dose reduction of osimertinib is indicated\n- Patients who are either pregnant, breastfeeding or actively trying to conceive"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Overall survival (OS)\n- Patient reported toxicity of any grade (laboratory abnormalities excluded)\n- Economic assessment\n- Quality of life\n- Cumulative incidence of central nervous system (CNS) metastases\n- Feasibility / medication adherence","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 283
- Recruitment Window Months
- 72
- Consent Approach
- Informed consent is provided by the participant (all participants must be aged ≥18 and able to give informed consent). Subject information sheets and informed consent forms for adults are provided; multiple language versions are available (English and country-language versions including Dutch and French as indicated by available ICF documents). No assent process is indicated.
Geography
- Total Number Of Sites
- 17
- Total Number Of Participants
- 283
Netherlands
- Earliest CTIS Part Ii Submission Date
- 13-10-2025
- Latest Decision Or Authorization Date
- 28-10-2025
- Processing Time Days
- 15
- Number Of Sites
- 7
- Number Of Participants
- 183
Sites
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Pulmonary Medicine
- Contact Person Name
- W.K. de Jong
- Contact Person Email
- W.K.deJong-9@umcutrecht.nl
- Site Name
- University Medical Center Groningen
- Department Name
- Pulmonary Medicine
- Contact Person Name
- A.J. van der Wekken
- Contact Person Email
- a.j.van.der.wekken@umcg.nl
- Site Name
- Leiden University Medical Center
- Department Name
- Pulmonary Medicine
- Contact Person Name
- E.F. Smit
- Contact Person Email
- e.f.smit@lumc.nl
- Site Name
- Radboud University Medical Center
- Department Name
- Pulmonary Medicine
- Contact Person Name
- M. van der Drift
- Contact Person Email
- Miep.vanderDrift@radboudumc.nl
- Site Name
- Amsterdam UMC
- Department Name
- Pulmonary Medicine
- Contact Person Name
- I. Bahce
- Contact Person Email
- i.bahce@amsterdamumc.nl
- Site Name
- Erasmus Medisch Centrum 1
- Department Name
- Pulmonary Medicine
- Contact Person Name
- A.C. Dingemans
- Contact Person Email
- a.dingemans@erasmusmc.nl
- Site Name
- Maastricht University Medical Center
- Department Name
- Pulmonary Medicine
- Contact Person Name
- L.E.L. Hendriks
- Contact Person Email
- lizza.hendriks@mumc.nl
Belgium
- Earliest CTIS Part Ii Submission Date
- 19-02-2026
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 36
- Number Of Sites
- 10
- Number Of Participants
- 100
Sites
- Site Name
- UZ Leuven
- Department Name
- Respiratory Medicine
- Contact Person Name
- Els Wauters
- Contact Person Email
- Els.wauters@uzleuven.be
- Site Name
- Antwerp Pediatric Clinical Trial Network
- Department Name
- Thoracic Oncology
- Contact Person Name
- Reinier Wener
- Contact Person Email
- reinier.wener@uza.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Pneumology
- Contact Person Name
- Ingel Demedts
- Contact Person Email
- ingel.demedts@azdelta.be
- Site Name
- Grand Hopital De Charleroi
- Department Name
- Oncology and Hematology
- Contact Person Name
- Benoit Colinet
- Contact Person Email
- benoit.colinet2@ghdc.be
- Site Name
- CHU Helora
- Department Name
- Oncology and Hematology
- Contact Person Name
- Stéphane Holbrechts
- Contact Person Email
- Stephane.holbrechts@helora.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Medicine
- Contact Person Name
- Sebahat Ocak
- Contact Person Email
- Sebahat.ocak@chuuclnamur.uclouvain.be
- Site Name
- UZ Gent
- Department Name
- Department of Respiratory Medicine/Thoracic Oncology
- Contact Person Name
- Verlee Surmont
- Contact Person Email
- veerle.surmont@uzgent.be
- Site Name
- UZ Brussel
- Department Name
- Medical Oncology
- Contact Person Name
- Lore Decoster
- Contact Person Email
- lore.decoster@uzbrussel.be
- Site Name
- Institut Jules Bordet
- Department Name
- Lung Oncology
- Contact Person Name
- Mariana Brandao
- Contact Person Email
- mariana.brandao@hubruxelles.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Pneumology
- Contact Person Name
- Frank Aboubakar
- Contact Person Email
- Frank.aboubakar@uclouvain.be
Sponsor
Primary sponsor
- Full Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- TAGRISSO 80 mg film-coated tablets
- Active Substance
- Osimertinib
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation EU)
- Starting Dose
- 80 mg
- Dose Levels
- 80 mg
- Frequency
- Once daily (QD) in standard arm; every other day (QOD) in experimental arm
- Maximum Dose
- 80 mg
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