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Recruiting Observational

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

NCT07028489 · tracked via the Priya Life Science Mexico tracker
Phase
Observational
Started
2025-06-05
Last updated
2026-09-22

Condition(s) studied

Non Small Cell Lung Cancer

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (10)

FacilityCityRegionStatus
Pacific Cancer Care Monterey California Recruiting
Torrance Memorial Physician Network-Cancer Care Torrance California Recruiting
John Muir Health Walnut Creek California Recruiting
Bayhealth Cancer Center- Kent Dover Delaware Recruiting
Bayhealth Cancer Center- Sussex Milford Delaware Recruiting
Kootenai Clinic Cancer Services Coeur d'Alene Coeur d'Alene Idaho Recruiting
Northwest Oncology & Hematology Elk Grove Village Illinois Recruiting
New Mexico Oncology Hematology Consultants Albuquerque New Mexico Recruiting
Lankenau Medical Center Paoli Pennsylvania Not Yet Recruiting
Oncology Consultants, P.A. Houston Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07028489 on ClinicalTrials.gov ↗ ← All trials in Mexico