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RecruitingObservational

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

NCT ID: NCT07028489Sponsor: N-Power MedicineLast updated: 2026-06-16

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.

Arms & interventions

Outcome measures

Primary

  • 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

  • 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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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.

Study locations (8)

Pacific Cancer Care

Monterey, California, 93940

Recruiting
Michael Z Koontz, MD · Principal Investigator

Torrance Memorial Physician Network-Cancer Care

Torrance, California, 90505

Recruiting
Clinical Research Coordinator · Contact
Swati Skiaria, MD · Principal Investigator

Bayhealth Cancer Center- Kent

Dover, Delaware, 19901

Recruiting
Stephanie McClellan · Contact
Iftekar Kahn, MD · Principal Investigator

Bayhealth Cancer Center- Sussex

Milford, Delaware, 19963

Recruiting
Stephanie McClellan · Contact

Kootenai Clinic Cancer Services Coeur d'Alene

Coeur d'Alene, Idaho, 83814

Recruiting
Clinical Research Coordinator · Contact
Jeffrey Allen, MD · Principal Investigator

Northwest Oncology & Hematology

Elk Grove Village, Illinois, 60007

Recruiting
Nowsheen Azeemuddin · Contact

Lankenau Medical Center

Paoli, Pennsylvania, 19301

Not Yet Recruiting
Jessica Burrell · Contact
Paul Gilman, MD · Principal Investigator

Oncology Consultants, P.A.

Houston, Texas, 77030

Recruiting
Research Office · Contact
· Contact