Observational Study of Osimertinib for EGFR-Mutant Lung Cancer

This is an observational study for people with newly diagnosed advanced or metastatic non-small cell lung cancer (NSCLC) that has specific EGFR gene changes (EGFR exon 19del or EGFR exon 21 L858R). The study aims to understand how well osimertinib works in a real-world setting by tracking how long patients live without their cancer getting worse (progression-free survival). You could be eligible if you are 18 or older, have this type of lung cancer diagnosed on or after January 1, 2024, and have not previously taken osimertinib or certain other drugs. The study plans to include about 130 participants.

Study design
This is an observational study, meaning researchers will collect information about your treatment and health over time. It is not a randomized trial where you would be assigned to a specific treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track your progression-free survival for up to 100 months from when you start your first treatment for metastatic disease.

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NCT07028489

Prospective External Control Cohort In Patients With Newly Diagnosed Advanced or Metastatic EGFR Mutant Non-Small Cell Lung Cancer

Recruiting
Not specifiedAges 18+Observational
N-Power Medicine
~130 participants
Updated 2026-07-16 on ClinicalTrials.gov

At a glance

Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess real world progression-free survival in patients with locally advanced or metastatic NSCLC treated with first line osimertinib
Measured over From the index date (date of initiation of first line treatment for metastatic disease) until date of progression or date of death whichever comes first, assessed up to 100 months)
Non Small Cell Lung Cancer
9 sites across 6 states
California3
Delaware2
Idaho1
Illinois1
Pennsylvania1
Texas1

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Eligibility criteria

Inclusion

Be ≥18 years of age at the time of informed consent
Evidence of a confirmed diagnosis of EGFR mutant (EGFR exon 19del or EGFR exon 21 L858R) locally advanced or metastatic NSCLC diagnosed on Jan 1st 2024 or later.

Exclusion

ECOG≥2 at diagnosis of advanced or metastatic NSCLC
Evidence of prior treatment with osimertinib, amivantamab or lazertinib. For the planned selection and analysis of external controls, further eligibility criteria will be applied according to the COPERNICUS SAP.
  • Assess real world progression-free survival in patients with locally advanced or metastatic NSCLC treated with first line osimertinibFrom the index date (date of initiation of first line treatment for metastatic disease) until date of progression or date of death whichever comes first, assessed up to 100 months)