Prospective external control cohort for newly diagnosed advanced EGFR‑mutant NSCLC
Prospective External Control Cohort In Patients With Newly Diagnosed Advanced or Metastatic EGFR Mutant Non-Small Cell Lung Cancer
This project will create a prospective group of people with newly diagnosed advanced EGFR‑mutant non‑small cell lung cancer to collect standardized clinical and imaging data as an external control for treatment comparisons.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | N-Power Medicine Industry-sponsored |
| Drugs / interventions | amivantamab, osimertinib, lazertinib |
| Locations | 6 sites (Monterey, California and 5 other locations) |
| Trial ID | NCT07028489 on ClinicalTrials.gov |
What this trial studies
The protocol enrolls adults with locally advanced or metastatic NSCLC harboring common EGFR mutations (exon 19 deletion or exon 21 L858R) diagnosed on or after January 1, 2024 and collects standardized data at baseline, during treatment, and at therapy discontinuation. Approximately 30% of participants who enroll before starting osimertinib will undergo imaging at predefined, standardized intervals. Key exclusions include ECOG performance status ≥2 and prior treatment with osimertinib, amivantamab, or lazertinib; additional analytic eligibility will follow the COPERNICUS statistical analysis plan. Enrollment is being conducted at three U.S. cancer centers and the cohort is intended to serve as a prospective external control for comparative analyses.
Who should consider this trial
Good fit: Adults (≥18) with newly diagnosed locally advanced or metastatic NSCLC carrying EGFR exon 19 deletion or exon 21 L858R, ECOG 0–1, diagnosed on or after Jan 1, 2024, and without prior osimertinib, amivantamab, or lazertinib treatment.
Not a fit: Patients with ECOG ≥2, prior exposure to osimertinib/amivantamab/lazertinib, non‑common EGFR mutations, or those unable to attend the participating sites or undergo standardized imaging are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the cohort could provide high‑quality prospective real‑world comparator data to help interpret outcomes of new EGFR‑targeted therapies and support clinical or regulatory decisions.
How similar studies have performed: Prospective registries and external control cohorts have been used successfully in oncology to contextualize trial outcomes, so this approach is established though the exact protocol and imaging standardization may differ.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Monterey, California and 5 other locations
- Pacific Cancer Care — Monterey, California, United States (Recruiting)
- Bayhealth Cancer Center- Kent — Dover, Delaware, United States (Recruiting)
- Bayhealth Cancer Center- Sussex — Milford, Delaware, United States (Recruiting)
- Northwest Oncology & Hematology — Elk Grove Village, Illinois, United States (Recruiting)
- Lankenau Medical Center — Paoli, Pennsylvania, United States (Not_yet_recruiting)
- Oncology Consultants, P.A. — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: N-Power Medicine Support
- Email: support@npowermedicine.com
- Phone: 1-833-467-6734
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.