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ERIS: EGFR-Mutated Lung Cancer in Randomized Investigator-Initiated Study
EU CTIS ID: 2024-518172-31-01
What this study is testing
To evaluate the optimal sequence of EGFR-inhibitors.
- Therapeutic confirmatory (Phase III)
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
- 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.
You likely can't join if
- Condition incompatible with the study or with the planned treatment.
- Gastrointestinal conditions incompatible with swallowing or precluding absorption of the study drug.
- Pregnancy or refusal to use contraceptives.
- Abnormal findings of blood chemistry not compatible with the study drug according to investigator.
- History of hypersensitivity to the study drug (or drugs with a similar chemical structure or class) or any excipients.
- Co-enrolment in other interventional trial if incompatible with ERIS according to investigator (e.g. due to potential drug interactions).
See the full eligibility criteria
- 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.
- Condition incompatible with the study or with the planned treatment.
- Gastrointestinal conditions incompatible with swallowing or precluding absorption of the study drug.
- Pregnancy or refusal to use contraceptives.
- Abnormal findings of blood chemistry not compatible with the study drug according to investigator.
- History of hypersensitivity to the study drug (or drugs with a similar chemical structure or class) or any excipients.
- Co-enrolment in other interventional trial if incompatible with ERIS according to investigator (e.g. due to potential drug interactions).
- Severe hepatic impairment/renal function incompatible with study drug according to investigator.
- Hereditary conditions with galactose intolerance, total lactase deficiency or glucose -galactose malabsorption.
- Congenital long QT syndrome.
- 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.
- Present second primary malignancy with metastatic potential.
- Intake of hypericum perforatum (intake must be interrupted before start of study treatment).
- 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.
- 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.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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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.