OSI-SAVE

Increasing the dosing interval of osimertinib in patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer

In order to be eligible to participate in this study, a patient must meet all of the following criteria:
– Age ≥18 years;
– Able to understand the written information and able to give informed consent;
– Sufficient knowledge of the local language in order to answer the questionnaires;
– Locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or exon 21 L858R
mutation, 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 physician.
– a radiological response according to the treating physician that does not meet the criteria for partial response according to RECIST 1.1

A potential patient who meets any of the following criteria will be excluded from participation in this
study:
– 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