Non Small Cell Lung Cancer
Conditions
Keywords
NSCLC, External Control Arm, Non-Interventional, N-Power Medicine, Registry, Prospective
Brief summary
A study to create control arms using current and future information in patients with lung cancer.
Interventions
None listed
Sponsors
N-Power Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \> 18 years of age at the time of informed consent 2. Pathologically confirmed locally advanced or metastatic NSCLC 3. ECOG Performance of less than or equal to 1 within 4 weeks prior to starting index therapy. 4. Life expectancy of more than 3 months 5. Able to understand and sign informed consent 6. Evidence of measurable disease (as assessed by the Investigator) on available imaging (e.g CT, MRI, PET) \*see protocol for cohort specific inclusion criteria\*
Exclusion criteria
1. Actively on a clinical trial of an investigational agent 2. Currently receiving active systemic therapy for another malignancy 3. Eligible for treatment with curative intent \*see protocol for cohort specific
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess Objective Response Rate (ORR) by cohort in patients with metastatic NSCLC treated in second or third line with NCCN recommended therapies | September 2025-April 2029 |
Secondary
| Measure | Time frame |
|---|---|
| Assess Progression Free Survival (PFS), Overall Survival (OS), and Time to Next Treatment (TTNT) by cohort in patients with metastatic NSCLC initiating second or third line treatment with NCCN recommended therapies. | September 2025-April2029 |
Countries
United States
Outcome results
None listed