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NCT07028489Recruiting

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

N-Power Medicine

Start Date

6/5/2025

Completion Date

4/1/2029

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 Criteria

Age Range: 18 years to No maximum

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.

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Conditions

Non Small Cell Lung Cancer

Locations

Pacific Cancer Care

Monterey, California 93940

United States

Torrance Memorial Physician Network-Cancer Care

Torrance, California 90505

United States

John Muir Health

Walnut Creek, California 94598

United States

Bayhealth Cancer Center- Kent

Dover, Delaware 19901

United States

Bayhealth Cancer Center- Sussex

Milford, Delaware 19963

United States

Kootenai Clinic Cancer Services Coeur d'Alene

Coeur d'Alene, Idaho 83814

United States

Northwest Oncology & Hematology

Elk Grove Village, Illinois 60007

United States

Lankenau Medical Center

Paoli, Pennsylvania 19301

United States

Oncology Consultants, P.A.

Houston, Texas 77030

United States