EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study
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.
• 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.
• Any WHO PS.
• Age ≥ 18 years, no upper age limit.
• EGFR-mutation in tumor (in cases where tumor tissue is not available for mutation analysis, circulating tumor-DNA (ctDNA) in plasma may serve as inclusion criteria), which is presumably predictive of sensitivity to EGFR TKI.
• Treatment-naive with regard to TKI's
• Negative pregnancy test (blood or urine test)
• For fertile participants, adequate contraception should be used; intrauterine device, bilateral tubal occlusion, vasectomy or abstinence (a reduced effect of hormonal contraception methods due to the drugs cannot be excluded). Pregnancy should be avoided during treatment and the first 4 months following treatment discontinuation.