Prospective External Control Cohort In Patients With Newly Diagnosed Advanced or Metastatic EGFR Mutant Non-Small Cell Lung Cancer
Recruiting · NCT07028489 · Observational (researchers observe without assigning treatment) · Lead sponsor: N-Power Medicine
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
9 locations listed across 6 US states.
- Pacific Cancer Care - Monterey, California, United States
- Torrance Memorial Physician Network-Cancer Care - Torrance, California, United States
- John Muir Health - Walnut Creek, California, United States
- Bayhealth Cancer Center- Kent - Dover, Delaware, United States
- Bayhealth Cancer Center- Sussex - Milford, Delaware, United States
- Kootenai Clinic Cancer Services Coeur d'Alene - Coeur d'Alene, Idaho, United States
- Northwest Oncology & Hematology - Elk Grove Village, Illinois, United States
- Lankenau Medical Center - Paoli, Pennsylvania, United States
- Oncology Consultants, P.A. - Houston, Texas, United States