Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients
Recruiting · NCT06538038 · Observational (researchers observe without assigning treatment) · Lead sponsor: PrECOG, LLC.
View the official record on ClinicalTrials.gov →Interventions studied
OsimertinibOsimertinib + Chemotherapy
What this trial is about
The goal of the study is to collect data on patients treated outside of a clinical trial (in routine clinical practice) with standard of care osimertinib with or without chemotherapy in Epidermal Growth Factor Receptor (EGFR)-mutant Non-Small Cell Lung Cancer (NSCLC) to better understand the safety and effectiveness of these standard of care regimens.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Patient must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC).
- Patient must have advanced disease, defined as IIIB (not amenable to definitive multi-modality therapy), IIIC, or IV (includes local or distant recurrent disease after a prior diagnosis of Stage I-III disease). All staging is via the American Joint Committee on Cancer (AJCC)/International Association for the Study of Lung Cancer (IASLC) 8th edition staging criteria.
- Patient tumor must have somatic activating sensitizing mutation in EGFR (e.g., but not limited to Exon 19 deletion, L858R, E709X, G719X, exon 19 insertions, L861Q, S768I). Patients with non-sensitizing mutations in EGFR (EGFR exon 20 insertions) are not eligible. Plasma, cytology, or tumor tissue can be utilized for standard of care mutation testing.
- Prior chemotherapy and/or immunotherapy administered as primary treatment for NSCLC before EGFR mutation was identified is allowed ≤ 45 days of study registration to allow for return of sequencing information.
- Prior treatment with osimertinib administered as primary treatment for NSCLC is allowed ≤ 30 days of study registration (prior treatment with any other EGFR TKI agent is not allowed).
- Patient must not be participating in EA5182 or any other cancer treatment trial. Osimertinib or osimertinib + chemotherapy/immunotherapy given as first-line treatment for this disease cannot be given as part of a clinical trial.
- Patients that have received prior radiation therapy in any setting for this disease are eligible.
- Adults age ≥ 18 years.
Where it is running
60 locations listed across 22 US states.
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- Mercy Clinic Fort Smith Communities - Fort Smith, Arkansas, United States
- Mercy Research - Fort Smith, Arkansas, United States
- Fowler Family Cancer Center - Jonesboro - Jonesboro, Arkansas, United States
- Stanford Cancer Center Emeryville - Emeryville, California, United States
- Stanford Cancer Institute Palo Alto - Palo Alto, California, United States
- Stanford Cancer Center South Bay - San Jose, California, United States
- John Muir Health - Walnut Creek, California, United States
- Bayhealth - Dover, Delaware, United States
- Satellite of Bayhealth Sussex - Milford, Delaware, United States
- Sibley Johns Hopkins University - Washington D.C., District of Columbia, United States
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: Liberty County Cancer Care - Hinesville, Georgia, United States
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: Regional Cancer Care - Jesup, Georgia, United States
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler - Savannah, Georgia, United States
- Advocate Good Shepherd Hospital - Barrington, Illinois, United States
- Northwestern University - Chicago, Illinois, United States
- John H Stroger Jr Hospital of Cook County - Chicago, Illinois, United States
- Advocate Illinois Masonic Medical Center - Chicago, Illinois, United States
- Northwestern Medicine Cancer Center Kishwaukee - DeKalb, Illinois, United States
- Northwestern Medicine Cancer Center Delnor - Geneva, Illinois, United States
- Northwestern Medicine Glenview Outpatient Center - Glenview, Illinois, United States
- Northwestern Medicine Grayslake Outpatient Center - Grayslake, Illinois, United States
- Advocate South Suburban Hospital - Hazel Crest, Illinois, United States
- Northwestern Medicine Lake Forest Hospital - Lake Forest, Illinois, United States
- Carle Cancer Institute Normal - Normal, Illinois, United States
- Advocate Christ Medical Center - Oak Lawn, Illinois, United States
- Northwestern Medicine Orland Park - Orland Park, Illinois, United States
- Advocate Lutheran General Hospital - Park Ridge, Illinois, United States
- Carle Founation Hospital - Urbana, Illinois, United States
- Northwestern Medicine Cancer Center Warrenville - Warrenville, Illinois, United States
- University of Maryland Greenebaum Comprehensive Cancer Center - Baltimore, Maryland, United States
- Greater Baltimore Medical Center - Baltimore, Maryland, United States
- Tufts Medical Center - Boston, Massachusetts, United States
- Lowell General Hosptial - Lowell, Massachusetts, United States
- Tufts Medical Center Cancer Center Stoneham - Stoneham, Massachusetts, United States
- Minnesota Oncology - Burnsville - Burnsville, Minnesota, United States
- Cambridge Medical Center - Cambridge, Minnesota, United States
- Mercy Hospital - Coon Rapids, Minnesota, United States
- Fairview Southdale Hospital - Edina, Minnesota, United States
- Fairview Clinics and Surgery Center Maple Grove - Maple Grove, Minnesota, United States
- Minnesota Oncology Hematology PA-Maplewood - Maplewood, Minnesota, United States
- Saint John's Hospital - Healtheast - Maplewood, Minnesota, United States
- Abbott-Northwestern Hospital - Minneapolis, Minnesota, United States
- Hennepin County Medical Center - Minneapolis, Minnesota, United States
- Health Partners Inc. - Minneapolis, Minnesota, United States
- Monticello Cancer Center - Monticello, Minnesota, United States
- New Ulm Medical Center - New Ulm, Minnesota, United States
- Fairview Northland Medical Center - Princeton, Minnesota, United States
- North Memorial Medical Health Center - Robbinsdale, Minnesota, United States
- Park Nicollet Clinic - Saint Louis Park - Saint Louis Park, Minnesota, United States
- Metro MN - Saint Louis Park, Minnesota, United States
- Regions Hospital - Saint Paul, Minnesota, United States
- United Hospital - Saint Paul, Minnesota, United States
- Saint Francis Regional Medical Center - Shakopee, Minnesota, United States
- Lakeview Hospital - Stillwater, Minnesota, United States
- Ridgeview Medical Center - Waconia, Minnesota, United States
- Rice Memorial Hospital - Willmar, Minnesota, United States
- Minnesota Oncology Hematology PA-Woodbury - Woodbury, Minnesota, United States
- Fairview Lakes Medical Center - Wyoming, Minnesota, United States
- Baptist Memorial Hospital and Cancer Center - Golden Triangle - Columbus, Mississippi, United States
Showing 60 of 146 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →