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
- 03-02-2025
- First CTIS Authorization Date
- 02-06-2025
Trial design
Osimertinib 80 mg once daily (QD) (standard dosing) versus Osimertinib 80 mg every other day (QOD) (extended dosing interval).-controlled trial across 8 sites in Netherlands, Belgium, France.
- Comparator
- Osimertinib 80 mg once daily (QD) (standard dosing) versus Osimertinib 80 mg every other day (QOD) (extended dosing interval).
- Target Sample Size
- 183
Eligibility
Recruits 183 No vulnerable population selected. Trial enrols adults only (Age ≥18 years). Participants must be able to understand the written information and give informed consent. No procedures for assent of minors are provided..
- Pregnancy Exclusion
- Patients who are either pregnant, breastfeeding or actively trying to conceive
- Vulnerable Population
- No vulnerable population selected. Trial enrols adults only (Age ≥18 years). Participants must be able to understand the written information and give informed consent. No procedures for assent of minors are provided.
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)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Patient reported toxicity of any grade (laboratory abnormalities excluded)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Economic assessment","definition_or_measurement_approach":""}
- {"endpoint_text":"- Quality of life","definition_or_measurement_approach":""}
- {"endpoint_text":"- Cumulative incidence of central nervous system (CNS) metastases","definition_or_measurement_approach":""}
- {"endpoint_text":"- Feasibility / medication adherence","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 183
- Recruitment Window Months
- 72
- Consent Approach
- Adults provide written informed consent themselves. Inclusion requires participants to be able to understand the written information and to give informed consent. Subject information and informed consent form documents for adults are listed; no assent procedures for minors are provided and no languages for the ICF are specified in the available record.
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 183
Netherlands
- Earliest CTIS Part Ii Submission Date
- 20-05-2025
- Latest Decision Or Authorization Date
- 02-06-2025
- Processing Time Days
- 13
- Number Of Sites
- 8
- Number Of Participants
- 183
Sites
- Site Name
- Erasmus Medisch Centrum 1
- Department Name
- Pulmonary Medicine
- Principal Investigator Name
- A.C. Dingemans
- Principal Investigator Email
- a.dingemans@erasmusmc.nl
- Contact Person Name
- A.C. Dingemans
- Contact Person Email
- a.dingemans@erasmusmc.nl
- Site Name
- University Medical Center Groningen
- Department Name
- Pulmonary Medicine
- Principal Investigator Name
- A.J. van der Wekken
- Principal Investigator Email
- a.j.van.der.wekken@umcg.nl
- 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
- Principal Investigator Name
- E.F. Smit
- Principal Investigator Email
- e.f.smit@lumc.nl
- Contact Person Name
- E.F. Smit
- Contact Person Email
- F.van_der_Kley@lumc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Pulmonary Medicine
- Principal Investigator Name
- W.K. de Jong
- Principal Investigator Email
- W.K.deJong-9@umcutrecht.nl
- Contact Person Name
- W.K. de Jong
- Contact Person Email
- W.K.deJong-9@umcutrecht.nl
- Site Name
- Radboud University Medical Center
- Department Name
- Pulmonary Medicine
- Principal Investigator Name
- M. van der Drift
- Principal Investigator Email
- Miep.vanderDrift@radboudumc.nl
- Contact Person Name
- M. van der Drift
- Contact Person Email
- Miep.vanderDrift@radboudumc.nl
- Site Name
- Amsterdam UMC
- Department Name
- Pulmonary Medicine
- Principal Investigator Name
- I. Bahce
- Principal Investigator Email
- i.bahce@amsterdamumc.nl
- Contact Person Name
- I. Bahce
- Contact Person Email
- i.bahce@amsterdamumc.nl
- Site Name
- Maastricht University Medical Center
- Department Name
- Pulmonary Medicine
- Principal Investigator Name
- L.E.L. Hendriks
- Principal Investigator Email
- lizza.hendriks@mumc.nl
- Contact Person Name
- L.E.L. Hendriks
- Contact Person Email
- loes.jansen@mumc.nl
- Site Name
- Leiden University Medical Center (alternate listing)
- Department Name
- Pulmonary Medicine
- Principal Investigator Name
- E.F. Smit
- Principal Investigator Email
- e.f.smit@lumc.nl
- Contact Person Name
- E.F. Smit
- Contact Person Email
- e.f.smit@lumc.nl
Belgium
France
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/1/16/1086/002)
- Starting Dose
- 80 mg
- Dose Levels
- 80 mg
- Frequency
- 80 mg QD (once daily) and 80 mg QOD (every other day)
- Maximum Dose
- 80 mg
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