ERIS: EGFR-Mutated Lung Cancer in Randomized Investigator-Initiated Study

Prior treatment

• Abnormal findings of blood chemistry not compatible with the study drug according to investigator.
• Co-enrolment in other interventional trial if incompatible with ERIS according to investigator (e.g. due to potential drug interactions).
• All subjects should avoid concomitant use of medications with known interaction with planned treatment, whenever feasible. If the administration of a medication interacts with any of the three investigational treatments and cannot be exchanged or managed in order to avoid interactions the patient is excluded from the trial.

Other illness

• Condition incompatible with the study or with the planned treatment.
• Gastrointestinal conditions incompatible with swallowing or precluding absorption of the study drug.
• History of hypersensitivity to the study drug (or drugs with a similar chemical structure or class) or any excipients.
• Severe hepatic impairment/renal function incompatible with study drug according to investigator.
• Present second primary malignancy with metastatic potential.
• Any evidence of severe or uncontrolled systemic diseases which in the investigator’s opinion makes it undesirable for the subject to participate in the trial or which would jeopardise compliance with the protocol. Screening for chronic conditions is not required.

Lab values

• Hereditary conditions with galactose intolerance, total lactase deficiency or glucose -galactose malabsorption.
• Congenital long QT syndrome.

Other

• Pregnancy or refusal to use contraceptives.
• Judgment by the investigator that the subject should not participate in the study, e.g., if the subject is unlikely to comply with study procedures, restrictions and requirements.
• Intake of hypericum perforatum (intake must be interrupted before start of study treatment).

• Written informed consent
• Negative pregnancy test (blood or urine test)
• Histological or cytological diagnosis of NSCLC.
• Clinical stage III/IV disease 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 or older.
• EGFR-mutation in tumor (in cases where tumor tissue is not available for mutation analysis, circulating tumour-DNA (ctDNA) in plasma may serve as inclusion criteria).
• Treatment-naive with regard to TKI’s.
• 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.