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

N-Power Medicine

Status: Enrolling

Conditions: Non Small Cell Lung Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT07028489

NPM-002

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

130 participants in 2 patient groups

Osimertinib plus chemo, or other regimens

Description:

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

Osimertinib monotherapy

Description:

Osimertinib monotherapy for newly diagnosed mNSCLC