RecruitingRecruiting
Prospective External Control Cohort In Patients With Newly Diagnosed Advanced or Metastatic EGFR Mutant Non-Small Cell Lung Cancer
NCT07028489 · N-Power Medicine
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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
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 design
Enrollment target: 130 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-06-05
Estimated completion: 2029-04
Last updated: 2026-07-16
Primary outcomes
- • 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))
Sponsor
N-Power Medicine · industry
Contacts & investigators
ContactN-Power Medicine Support · contact · support@npowermedicine.com · 1-833-467-6734
All locations (9)
Pacific Cancer CareRecruiting
Monterey, California, United States
Torrance Memorial Physician Network-Cancer CareRecruiting
Torrance, California, United States
John Muir HealthRecruiting
Walnut Creek, California, United States
Bayhealth Cancer Center- KentRecruiting
Dover, Delaware, United States
Bayhealth Cancer Center- SussexRecruiting
Milford, Delaware, United States
Kootenai Clinic Cancer Services Coeur d'AleneRecruiting
Coeur d'Alene, Idaho, United States
Northwest Oncology & HematologyRecruiting
Elk Grove Village, Illinois, United States
Lankenau Medical CenterNot Yet Recruiting
Paoli, Pennsylvania, United States
Oncology Consultants, P.A.Recruiting
Houston, Texas, United States