Prospective External Control Cohort In Patients With Newly Diagnosed Advanced or Metastatic EGFR Mutant Non-Small Cell Lung Cancer
Purpose
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.
Condition
- Non Small Cell Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Osimertinib plus chemo, or other regimens | Osimertinib plus chemo, or other regimens in the metastatic setting initiated on or after January 1, 2024 | |
| Osimertinib monotherapy | Osimertinib monotherapy for newly diagnosed mNSCLC |
Recruiting Locations
Pacific Cancer Care
Monterey, California 93940
Monterey, California 93940
Torrance Memorial Physician Network-Cancer Care
Torrance, California 90505
Torrance, California 90505
John Muir Health
Walnut Creek, California 94598
Walnut Creek, California 94598
Bayhealth Cancer Center- Kent
Dover, Delaware 19901
Dover, Delaware 19901
Bayhealth Cancer Center- Sussex
Milford, Delaware 19963
Milford, Delaware 19963
Kootenai Clinic Cancer Services Coeur d'Alene
Coeur d'Alene, Idaho 83814
Coeur d'Alene, Idaho 83814
Northwest Oncology & Hematology
Elk Grove Village, Illinois 60007
Elk Grove Village, Illinois 60007
Oncology Consultants, P.A.
Houston, Texas 77030
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- N-Power Medicine