RecruitingNCT07028489

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

Sponsor

N-Power Medicine

Enrollment

130 participants

Start Date

Jun 5, 2025

Study Type

OBSERVATIONAL

Conditions

Non-small Cell Lung Cancer

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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 Criteria2

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.