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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects health data from adults with newly diagnosed non-small cell lung cancer that has spread nearby or to other parts of the body and has certain changes in the EGFR gene. Data are collected before, during, and when treatment ends. People who join before starting osimertinib will have scans on a set schedule.

The objective of this study is to build a prospective cohort in patients with locally advanced or metastatic NSCLC with common EGFR mutations. In NPM-002, there will be standardized data collection at baseline, on-treatment and at discontinuation of therapy. Patients who enroll prior to initiation of osimertinib treatment (\~30%) will undergo imaging with standardized intervals.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 or older when you agree to join.
  • Have confirmed non-small cell lung cancer that has spread nearby or to other parts of the body, diagnosed on January 1, 2024, or later.
  • The cancer must have one of these EGFR gene changes: exon 19 deletion or exon 21 L858R.

Who can't join

  • Have an ECOG score of 2 or higher when advanced or spread-out cancer is diagnosed. This means health limits your daily activity enough that you cannot work.
  • Have already received osimertinib, amivantamab, or lazertinib.
  • More rules will apply when choosing patients whose data will be used for comparison, based on the COPERNICUS study analysis plan.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

INCLUSION CRITERIA * 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 CRITERIA * 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.

Study sites (10)

CA

DE

ID

IL

NM

PA

TX