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New treatment option for Non-Small Cell Lung Cancer
Official title EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study
ClinicalTrials.gov ID: NCT06486142
What this study is testing
What is Afatinib/Dacomitinib?
Afatinib/Dacomitinib is an investigational medicine, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as Study participants receiving afatinib or dacomitinib until tumor progression/other reasons.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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 treatment 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).
- All people should avoid concomitant use of medications with known interaction with planned treatment, whenever feasible. If the administration of a...
- Drugs that can either increase or decrease the concentration of osimertinib in plasma:
See the full eligibility criteria
- 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 ), 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...
- 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 treatment 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).
- All people 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...
- Drugs 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.
- Drugs 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
- Drugs 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...
- 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 jeopardize compliance with the protocol...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lund, Sweden
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lund, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.