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

N-Power Medicine130 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

130

Conditions

Non Small Cell Lung Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Pacific Cancer Care

Monterey, California, United States

RECRUITING

Bayhealth Cancer Center- Kent

Dover, Delaware, United States

RECRUITING

Bayhealth Cancer Center- Sussex

Milford, Delaware, United States

RECRUITING

Outcomes

Primary Outcomes

Assess real world progression-free survival in patients with locally advanced or metastatic NSCLC treated with first line osimertinib

Time frame: 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)

Secondary Outcomes

Assess overall survival in patients with locally advanced or metastatic NSCLC treated with first line osimertinib

Time frame: From the index date (date of initiation of first line treatment for metastatic disease) until death, as assessed up to 100 months

Assess time to treatment discontinuation in patients with locally advanced or metastatic NSCLC treated with first line osimertinib

Time frame: From the index date (date of initiation of first line treatment for metastatic disease) until treatment discontinuation, as assessed up to 100 months

Central Contacts

N-Power Medicine Support

CONTACT

1-833-467-6734 support@npowermedicine.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.