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

NCT07028489 | Recruiting

• 1 other identifier: NPM-002
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 6

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

Keywords

metastatic; advanced

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Assess overall 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 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

  From the index date (date of initiation of first line treatment for metastatic disease) until treatment discontinuation, as assessed up to 100 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with EGFR mutant locally advanced or metastatic NSCLC diagnosed from Jan 1st 2024 until the enrollment period ends.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• N-Power Medicine: lead

Study Sites (6)

Pacific Cancer Care

Monterey, California, 93940, United States

RECRUITING

Bayhealth Cancer Center- Kent

Dover, Delaware, 19901, United States

RECRUITING

Bayhealth Cancer Center- Sussex

Milford, Delaware, 19963, United States

RECRUITING

Northwest Oncology & Hematology

Elk Grove Village, Illinois, 60007, United States

RECRUITING

Lankenau Medical Center

Paoli, Pennsylvania, 19301, United States

NOT YET RECRUITING

Oncology Consultants, P.A.

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

N-Power Medicine Support

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 19, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (6)