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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07028489

Enrollment

130

Registered

2025-06-19

Start date

2025-06-05

Completion date

2029-04-01

Last updated

2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

metastatic, advanced

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Contacts

CONTACTN-Power Medicine Support

support@npowermedicine.com1-833-467-6734

Outcome results