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EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study

ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Afatinib/Dacomitinib

    Drug

    Second-generation EGFR-inhibitors

  • Osimertinib

    Drug

    Third-generation EGFR-inhibitor

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Afatinib/DacomitinibActive comparator 1 intervention
Group B: OsimertinibActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

Time frame
Maximum 6 years

Secondary outcomes

1

Time on TKI-treatment

Time frame
Maximum 6 years
2

Objective response rate

Time frame
Maximum 6 years
3

Disease control rate

Time frame
Maximum 6 years
4

Overall survival

Time frame
Maximum 6 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Skane

Lead sponsor

Swedish Lung Cancer Study Group

Collaborator

Source ClinicalTrials.gov
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