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Increasing the dosing interval of osimertinib in patients with EGFR mutated locally advanced or meta-static non-small cell lung cancer - OSI-SAVE
EU CTIS ID: 2024-514693-47-01
What this study is testing
The assessment of the non-inferiority of an extended dosing interval of osimertinib compared to the standard dosage.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.)
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.