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

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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pacific Cancer Care, Monterey, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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 outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

N-Power Medicine Support

CONTACT

[email protected]

1-833-467-6734

Sponsors and collaborators

Lead sponsor

N-Power Medicine

Industry

Registry information

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2029
First posted: Jun 19, 2025
Registry last updated: Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting