EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study
ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane
About this trial
The purpose of this study is to evaluate the optimal sequence of EGFR-inhibitors in lung cancer patients with EGFR-positive tumors not amenable for curative treatment. Life quality, adverse effects and tumor response will be evaluated and analyses of obtained blood and tumor samples will be performed to identify molecular profiles and biomarkers that can be used for treatment decisions.
Eligibility criteria
Qualifiers
The subject has given written consent to participate in the study.
Histological or cytological diagnosis of NSCLC.
Clinical stage III/IV disease (with or without CNS metastasis) or a recurrence not amenable for curative treatment intention.
Measurable disease according to RECIST 1.1 criteria or equivalent/modified criteria.
Disqualifiers
Condition incompatible with the study or with the planned treatment.
Present (not radically treated/no planned radical treatment of) other primary malignancy with metastatic potential.
Co-enrolment in other interventional trial if incompatible with ERIS according to investigator (e.g. due to potential drug interactions).
Intake of hypericum perforatum (intake must be interrupted before start of study treatment).
Trial design
Treatments tested in this trial
- Afatinib/Dacomitinib
- Osimertinib
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Region Skane
Lead sponsor
Swedish Lung Cancer Study Group
Collaborator
Source ClinicalTrials.gov