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

NCT ID: NCT07028489

Last Updated: 2025-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-05

Study Completion Date

2029-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Osimertinib plus chemo, or other regimens

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

No interventions assigned to this group

Osimertinib monotherapy

Osimertinib monotherapy for newly diagnosed mNSCLC

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

N-Power Medicine

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pacific Cancer Care

Monterey, California, United States

Site Status RECRUITING

Bayhealth Cancer Center- Kent

Dover, Delaware, United States

Site Status RECRUITING

Bayhealth Cancer Center- Sussex

Milford, Delaware, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

N-Power Medicine Support

Role: CONTACT

1-833-467-6734

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Study Coordinator

Role: primary

831-375-4105

Stephanie McClellan

Role: primary

302-744-7995

Stephanie McClellan

Role: primary

302-744-7995

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NPM-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.