External control arm registry for non-small cell lung cancer
A Prospective Study to Generate Precision External Controls in Advanced or Metastatic Non Small Cell Lung Cancer Patients
This project will build control groups from current and future clinical and registry data to help compare treatments for adults with non-small cell lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 550 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | N-Power Medicine Industry-sponsored |
| Locations | 8 sites (Monterey, California and 7 other locations) |
| Trial ID | NCT07174388 on ClinicalTrials.gov |
What this trial studies
This observational registry collects current and future clinical data from adults with pathologically confirmed non-small cell lung cancer to create external control arms. Data collected may include demographics, treatment history, imaging, performance status, and outcomes from participating clinical sites and registries. Eligible participants are adults (≥18) with confirmed NSCLC who are fit for further systemic therapy within the specified treatment window and able to consent, while exclusions include inability to consent or concurrent enrollment in an investigational treatment trial. The assembled external control cohorts are intended to support more meaningful comparisons against patients receiving new therapies or enrolled in interventional studies.
Who should consider this trial
Good fit: Adults (≥18) with pathologically confirmed non-small cell lung cancer who have ECOG performance >1, are fit for further systemic therapy within the defined time window, and can provide informed consent are ideal candidates.
Not a fit: Patients actively enrolled in a clinical trial of an investigational agent or those unable to provide informed consent are not appropriate for and likely will not benefit from participation.
Why it matters
Potential benefit: If successful, this could provide better-matched real-world control groups to help interpret treatment outcomes and speed understanding of what works in NSCLC.
How similar studies have performed: External control arms derived from registries and real-world data have been used successfully in some oncology settings, but success varies and depends on data quality and comparability.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. \> 18 years of age at the time of informed consent 2. Pathologically confirmed NSCLC 3 .ECOG Performance of \>1 and fit for further systemic therapy on a NCCN approved regimen (within 4 weeks prior or 14 days after starting second line therapy) 4. Life expectancy of more than 3 months 5. Able to understand and sign informed consent \*see protocol for cohort specific inclusion criteria\* Exclusion Criteria: 1. Unable to provide informed consent 2. Actively on a clinical trial of an investigational agent 3. Non protocol compliant baseline imaging scan (modality/coverage) prior to index date in patients included after the second or third line therapy has been initiated \*see protocol for cohort specific exclusion criteria\* -
Where this trial is running
Monterey, California and 7 other locations
- Pacific Cancer Care — Monterey, California, United States (Recruiting)
- Bayhealth Medical Center, Kent Campus — Dover, Delaware, United States (Recruiting)
- Bayhealth Medical Center- Sussex Campus — Milford, Delaware, United States (Recruiting)
- Northwest Oncology and Hematology — Barrington, Illinois, United States (Recruiting)
- Northwest Oncology and Hematology — Elk Grove, Illinois, United States (Recruiting)
- Northwest Oncology and Hematology — Hoffman Estates, Illinois, United States (Recruiting)
- Northwest Oncology and Hematology — Rolling Meadows, Illinois, United States (Recruiting)
- Oncology Consultants — Houston, Texas, United States (Recruiting)
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.