ERIS- a national study on characterization of EGFR-positive lung cancer

Phase 1

• Conditions: EGFR-mutated non-small cell lung cancer (NSCLC) not amenable for curative treatment intention and candidates for EGFR-inhibitor in first line.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-003755-41-SE
• Lead Sponsor: Region Skåne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-27
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

To be included in the study, subjects must meet the following criteria:
•The subject has given written consent to participate in the study.
•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, no upper age limit.
•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
•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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

Subjects must not be included in the study if any of the following criteria are met:
•Condition incompatible with the study or with the planned treatment.
•Present second primary malignancy with metastatic potential.
•Intake of hypericum perforatum.
•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.

oDrugs that can either increase or decrease the concentration of osimertinib in plasma:
?Strong activators of CYP3A. Simultaneous administration should be avoided.
?Regular CYP3A4-inhibitors should be used with caution or be avoided.
oDrugs that can either increase or decrease the concentration of afatinib in plasma:
?Strong inhibitors of P-glycoprotein should not be administered simultaneously with afatinib, instead it should preferably be 6-12 hours between.
?Strong activators of P-glycoprotein may reduce exposure of afatinib
oDrugs that can either increase or decrease the concentration of dacomitinib in plasma:
?Proton pump inhibitors should be avoided.
?Simultaneous administration of drugs that are metabolized by CYP2D6 should be avoided. If simultaneous use of that kind of medications are considered necessary, dose recommendations for simultaneous use of respective drug should be followed.

•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.
•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.
•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified