Lung cancer drug order trial aims to extend life and ease side effects

NCT ID NCT06486142

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 3 trial is testing which sequence of EGFR-inhibitor drugs works best for people with advanced EGFR-mutated lung cancer. About 200 participants will receive either a second-generation drug (afatinib or dacomitinib) followed by a third-generation drug (osimertinib), or osimertinib alone. The study measures how long the cancer is controlled, quality of life, and side effects, and also analyzes blood and tumor samples to find markers that could guide future treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EGFR-inhibitors (afatinib, dacomitinib, osimertinib)
What this could lead to
If successful, this could identify the best sequence of targeted drugs to control advanced lung cancer longer and improve quality of life.
What could go wrong
This is a phase 3 trial, but results may not apply to all patients. Side effects from these drugs can be significant, and the optimal sequence may not clearly outperform current practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 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. Exclusion Criteria: * 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 interventional 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 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. * 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 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 jeopardize 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Skåne university hospital

    RECRUITING

    Lund, Sweden

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