Recruiting

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

Sponsor:

N-Power Medicine

Code:

NCT07028489

Conditions

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Non Small Cell Lung Cancer

Study ID

NCT07028489

Start date

Jun 5, 2025

Status verified date

Jul, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

130 participants

Anticipated

Interventions and Outcome Measures

Arms

Osimertinib plus chemo, or other regimens

Osimertinib plus chemo, or other regimens in the metastatic setting initiated on or after January 1, 2024

Osimertinib monotherapy

Osimertinib monotherapy for newly diagnosed mNSCLC

Primary outcome measure

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) ]

Central Contacts and Locations

Central contacts

N-Power Medicine Support

1-833-467-6734 support@npowermedicine.com

Locations

Pacific Cancer Care

Recruiting

Monterey, California, United States, 93940

Contacts

Study Coordinator

831-375-4105 alexanderbaskoro@npowermedicine.com

Principal Investigator:

Michael Z Koontz, MD

Torrance Memorial Physician Network-Cancer Care

Recruiting

Torrance, California, United States, 90505

Contacts

Clinical Research Coordinator

310-750-3300 clinical-trials@tmphysicians.com

Principal Investigator:

Swati Skiaria, MD

John Muir Health

Recruiting

Walnut Creek, California, United States, 94598

Contacts

Suzanne Clinical Research Coordinator

925-692-5603 suzanne.brennan@johnmuirhealth.com

Principal Investigator:

GiGi Chen, MD

Bayhealth Cancer Center- Kent

Recruiting

Dover, Delaware, United States, 19901

Contacts

Stephanie McClellan

302-744-7995 Clinical_trials@bayhealth.org

Principal Investigator:

Iftekar Kahn, MD

Bayhealth Cancer Center- Sussex

Recruiting

Milford, Delaware, United States, 19963

Contacts

Stephanie McClellan

302-744-7995 Clinical_trials@bayhealth.org

Kootenai Clinic Cancer Services Coeur d'Alene

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

Clinical Research Coordinator

1-208-725-3522 ebrewer@kh.org

Principal Investigator:

Jeffrey Allen, MD

Northwest Oncology & Hematology

Recruiting

Elk Grove Village, Illinois, United States, 60007

Contacts

Nowsheen Azeemuddin

8474373312 nowsheena@northwestoncology.com

Oncology Consultants, P.A.

Recruiting

Houston, Texas, United States, 77030

Contacts

Research Office

713-600-0913 support@npowermedicine.com

1-833-4NPM-REG

More Information

Sponsor

N-Power Medicine

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

metastatic
advanced

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by N-Power Medicine on 2026-07-16.