Non-Small Cell Lung CancerPhase 3ERISNCT06486142
EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study
A Phase 3 study testing Afatinib/Dacomitinib and Osimertinib in people with Non-Small Cell Lung Cancer, run by Region Skane at 1 site in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Afatinib/Dacomitinib and Osimertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 21 Sep 2022to Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Skåne university hospital
Lund
Maria Planck, MD,PhD, 004646171000, maria.planck@skane.se
About this study
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.
Read the detailed description
ERIS is an investigator-initiated randomized phase III trial. Non-small cell lung cancer (NSCLC) patients with advanced disease, not amenable for curative treatment, are considered for targeted therapy. For first-line treatment in patients with EGFR-positive tumors there are now several options, of which osimertinib (a third generation EGFR-TKI) and dacomitinib/afatinib (second generation EGFR-TKIs) are considered first-hand choices. Dacomitinib/afatinib treatment might be switched to osimertinib in the event of treatment failure, provided that an EGFR T790M mutation is detected. However, in about half of patients with second generation EGFR- TKI treatment failure, the resistance mechanism is different from T790M. Thus, there is a need to identify which patients that benefit from osimertinib in first line and which patients that rather benefit from a second-generation EGFR-TKI in first line, respectively. Early treatment prediction and monitoring through biomarkers in blood and tumor could be one step forward in individualized treatment.
After being informed about the study patients with EGFR-positive NSCLC, considered for first-line treatment, will sign a consent and undergo a screening period to determine eligibility for study entry. When screening is completed, and inclusion criteria are met, study participants will be randomized in a 1:1 ratio to osimertinib or afatinib/dacomitinib.
Patients randomized to afatinib/dacomitinib will be able to cross-over to osimertinib in the event of progression and confirmed T790M-mutation. In the event of progression on osimertinib or on afatinib/dacomitinib without T790M, the study participants will be treated as chosen by the investigator and in accordance with applicable national guidelines.
Longitudinal blood samples and, when appropriate, tumor tissue/cytology or other fluids (pleural effusion etc.) will be assembled and used for comprehensive analysis to study potential biomarkers.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Afatinib/Dacomitinib, Osimertinib
- Keywords
- Non-small cell lung cancer, EGFR, Osimertinib, Afatinib, Dacomitinib, ctDNA, Resistance mechanisms
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afatinib/DacomitinibDrug
Also called Study participants receiving afatinib or dacomitinib until tumor progression/other reasons
Second-generation EGFR-inhibitors
OsimertinibDrug
Also called Study participants receiving osimertinib until tumor progression/other reasons
Third-generation EGFR-inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Afatinib/Dacomitinib | Active comparator | Not described Receives: Drug: Afatinib/Dacomitinib |
| Osimertinib | Active comparator | Not described Receives: Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: Maximum 6 years
Secondary outcomes (7)
Time on TKI-treatment
Measured: Maximum 6 years
Objective response rate
Measured: Maximum 6 years
Disease control rate
Measured: Maximum 6 years
Overall survival
Measured: Maximum 6 years
Quality of life
Participants answer nine questions about symptoms, daily functioning, well-being, and quality of life by marking a visual assessment scale. A score of 0 mm indicates no symptoms, while 100 mm indicates the worst possible symptoms or the lowest level of quality of life or functioning.
treatment arms
Measured: Maximum 6 years
Hereditary genetic alterations
The frequency of germline DNA variants will be studiedassociated with cancer predisposition will be investigated
Measured: Within 15 years from end of study
Identification of potential blood-borne biomarkers of treatment prediction and resistance
Levels of circulating proteins and cell free DNA will be measured at baseline and every visit throughout the study
Measured: Within 15 years from end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start21 Sep 2022
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Lung Cancer Study Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486142
- Sponsor's protocol ID
- 2021-003755-41
- Acronym
- ERIS
- Status last verified
- May 2026
- First submitted
- 7 May 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study
- ClinicalTrials.gov ID
- NCT06486142
- Acronym / sponsor ID
- ERIS / 2021-003755-41
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, EGFR, Osimertinib, Afatinib, Dacomitinib, ctDNA, Resistance mechanisms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Swedish Lung Cancer Study Group
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ERIS is an investigator-initiated randomized phase III trial. Non-small cell lung cancer (NSCLC) patients with advanced disease, not amenable for curative treatment, are considered for targeted therapy. For first-line treatment in patients with EGFR-positive tumors there are now several options, of which osimertinib (a third generation EGFR-TKI) and dacomitinib/afatinib (second generation EGFR-TKIs) are considered first-hand choices. Dacomitinib/afatinib treatment might be switched to osimertinib in the event of treatment failure, provided that an EGFR T790M mutation is detected. However, in about half of patients with second generation EGFR- TKI treatment failure, the resistance mechanism is different from T790M. Thus, there is a need to identify which patients that benefit from osimertinib in first line and which patients that rather benefit from a second-generation EGFR-TKI in first line, respectively. Early treatment prediction and monitoring through biomarkers in blood and tumor could be one step forward in individualized treatment.
After being informed about the study patients with EGFR-positive NSCLC, considered for first-line treatment, will sign a consent and undergo a screening period to determine eligibility for study entry. When screening is completed, and inclusion criteria are met, study participants will be randomized in a 1:1 ratio to osimertinib or afatinib/dacomitinib.
Patients randomized to afatinib/dacomitinib will be able to cross-over to osimertinib in the event of progression and confirmed T790M-mutation. In the event of progression on osimertinib or on afatinib/dacomitinib without T790M, the study participants will be treated as chosen by the investigator and in accordance with applicable national guidelines.
Longitudinal blood samples and, when appropriate, tumor tissue/cytology or other fluids (pleural effusion etc.) will be assembled and used for comprehensive analysis to study potential biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Afatinib/Dacomitinib | Active comparator | Drug: Afatinib/Dacomitinib |
| Osimertinib | Active comparator | Drug: Osimertinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afatinib/DacomitinibAlso: Study participants receiving afatinib or dacomitinib until tumor progression/other reasonsSecond-generation EGFR-inhibitors | Drug | Afatinib/Dacomitinib |
| OsimertinibAlso: Study participants receiving osimertinib until tumor progression/other reasonsThird-generation EGFR-inhibitor | Drug | Osimertinib |
Primary outcome
Progression-free survival (PFS)
Time frame: Maximum 6 years
7 secondary outcomes
Time on TKI-treatment
Time frame: Maximum 6 years
Objective response rate
Time frame: Maximum 6 years
Disease control rate
Time frame: Maximum 6 years
Overall survival
Time frame: Maximum 6 years
Quality of life
Time frame: Maximum 6 years
Hereditary genetic alterations
Time frame: Within 15 years from end of study
Identification of potential blood-borne biomarkers of treatment prediction and resistance
Time frame: Within 15 years from end of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Afatinib/Dacomitinib and Osimertinib in people with Non-Small Cell Lung Cancer, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Planck, MD, PhD (004646171000, maria.planck@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Maximum 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.