Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients
- Conditions
- Non Small Cell Lung CancerEpidermal Growth Factor Receptor Gene MutationStage III Lung CancerStage IV Lung Cancer
- Interventions
- Registration Number
- NCT06538038
- Lead Sponsor
- PrECOG, LLC.
- Brief Summary
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.
- Detailed Description
This study tests the feasibility of using real-world data collection through the recruitment of well-characterized patients into a registry, spanning academic and community practice sites to determine patient outcomes in all-comers. The scientific community would further benefit from a greater understanding of the safety and effectiveness of newly approved therapies prescribed in routine clinical practice.
Non-interventional (observational) study with 250 participants per exposure group (maximum accrual up to 538 total participants) comparing outcomes in patients with EGFR-mutated NSCLC, not being treated in a clinical trial but receiving standard of care osimertinib +/- chemotherapy.
The treating physician determines whether a patient will receive standard of care single agent osimertinib or osimertinib with chemotherapy and the planned treatment is recorded at registration.
Clinical/Imaging assessments will be per the treating physician.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 538
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Osimertinib Osimertinib Group 2 Osimertinib + Chemotherapy Osimertinib + Chemotherapy
- Primary Outcome Measures
Name Time Method real-world Progression-Free Survival (rwPFS) From initiation of therapy to progression or death, up to 3 years Time from initiating therapy to progression or death without documented progression
- Secondary Outcome Measures
Name Time Method real-world Overall Survival (rwOS) From initiation of therapy to death, up to 3 years Time from initial therapy to death from any cause.
real-world time to treatment discontinuation (rwTTD) From initiation of therapy to discontinuation of osimertinib, up to 3 years Time from treatment initiation (osimertinib or osimertinib + chemotherapy) to discontinuation of osimertinib.
Trial Locations
- Locations (73)
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
Baptist Cancer Center - Grenada
🇺🇸Grenada, Mississippi, United States
Jackson Oncology Associates PLLC
🇺🇸Jackson, Mississippi, United States
Mississippi Baptist Medical Center
🇺🇸Jackson, Mississippi, United States
Baptist Memorial Hospital and Cancer Center - Union
🇺🇸New Albany, Mississippi, United States
Baptist Memorial Hospital and Cancer Center - Oxford
🇺🇸Oxford, Mississippi, United States
Baptist Memorial Hospital and Cancer Center - Desoto
🇺🇸Southhaven, Mississippi, United States
Mercy Clinic Joplin, LLC
🇺🇸Joplin, Missouri, United States
Mercy Clinic Cancer and Hematology
🇺🇸Rolla, Missouri, United States
Mercy Clinic East Communities
🇺🇸Saint Louis, Missouri, United States
Mercy Clinic Springfield Communities
🇺🇸Springfield, Missouri, United States
Virtua Samson Cancer Center
🇺🇸Moorestown, New Jersey, United States
Atlantic Health Cancer Consortium Community Oncology Research Program
🇺🇸Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
The Valley Hospital - Luckow Pavilion
🇺🇸Paramus, New Jersey, United States
Virtua Voorhees
🇺🇸Voorhees, New Jersey, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Aultman
🇺🇸Canton, Ohio, United States
Miami Valley Hospital North
🇺🇸Englewood, Ohio, United States
Mercy Clinic Oklahoma Communities, Inc.
🇺🇸Oklahoma City, Oklahoma, United States
Lankenau Medical Center
🇺🇸Paoli, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Baptist Memorial Hospital and Cancer Center - Collierville
🇺🇸Collierville, Tennessee, United States
Baptist Memorial Hospital and Cancer Center - Memphis
🇺🇸Memphis, Tennessee, United States
Baptist Memorial Hospital for Women
🇺🇸Memphis, Tennessee, United States
UT Southwest
🇺🇸Dallas, Texas, United States
JPS Oncology & Infusion Center
🇺🇸Fort Worth, Texas, United States
ThedaCare Regional Cancer Center
🇺🇸Appleton, Wisconsin, United States
ThedaCare Regional Medical Center - Appleton
🇺🇸Appleton, Wisconsin, United States
ThedaCare Cancer Care - Berlin
🇺🇸Berlin, Wisconsin, United States
Mercyhealth Hospital and Cancer Center - Janesville
🇺🇸Janesville, Wisconsin, United States
Gundersen Lutheran Medical Foundation
🇺🇸La Crosse, Wisconsin, United States
Aurora NCORP
🇺🇸Milwaukee, Wisconsin, United States
ThedaCare Regional Medical Center - Neenah
🇺🇸Neenah, Wisconsin, United States
ThedaCare Cancer Care - New London
🇺🇸New London, Wisconsin, United States
ThedaCare Cancer Care - Oshkosh
🇺🇸Oshkosh, Wisconsin, United States
ThedaCare Cancer Care - Shawano
🇺🇸Shawano, Wisconsin, United States
ProHealth
🇺🇸Waukesha, Wisconsin, United States
ThedaCare Cancer Care - Waupaca
🇺🇸Waupaca, Wisconsin, United 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
John Muir Health
🇺🇸Walnut Creek, California, United States
Bayhealth
🇺🇸Dover, Delaware, United States
Satellite of Bayhealth Sussex
🇺🇸Milford, Delaware, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, 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