Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06486142

EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study

Led by Region Skane · Updated on 2026-05-14

200

Participants Needed

1

Research Sites

310 weeks

Total Duration

On this page

Sponsors

R

Region Skane

Lead Sponsor

S

Swedish Lung Cancer Study Group

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The subject has given written consent to participate in the study.
  • Histological or cytological diagnosis of NSCLC.
  • Clinical stage III or IV disease (with or without CNS metastasis) or a recurrence not suitable for curative treatment.
  • Measurable disease according to RECIST 1.1 or equivalent criteria.
  • Any World Health Organization performance status.
  • Age 18 years or older, no upper age limit.
  • Presence of EGFR mutation in tumor or circulating tumor-DNA predicting sensitivity to EGFR TKI.
  • No prior treatment with EGFR tyrosine kinase inhibitors.
  • Negative pregnancy test (blood or urine).
  • Fertile participants must use adequate contraception during treatment and for 4 months after stopping treatment.
Not Eligible

You will not qualify if you...

  • Condition incompatible with the study or planned treatment.
  • Untreated or non-radically treated other primary malignancy with metastatic potential.
  • Participation in other interventional trials incompatible with this study.
  • Current use of hypericum perforatum (St. John's Wort) which must be stopped before treatment.
  • Use of medications that interact with study drugs and cannot be managed to avoid interactions.
  • Severe or uncontrolled systemic diseases making participation undesirable or compliance difficult.
  • Gastrointestinal conditions preventing swallowing or absorption of study drugs.
  • Pregnancy or refusal to use contraception.
  • Abnormal blood chemistry incompatible with study drugs.
  • History of hypersensitivity to study drugs or similar agents.
  • Severe liver or kidney impairment incompatible with study drugs.
  • Hereditary conditions like galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
  • Congenital long QT syndrome.
  • Investigator judgment that subject should not participate, including likely non-compliance.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Skåne university hospital

Lund, Sweden

Actively Recruiting

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Research Team

M

Maria Planck, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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