Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients
Launched by PRECOG, LLC. · Jul 31, 2024
Trial Information
Current as of August 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how well a medication called osimertinib, with or without chemotherapy, works for patients with advanced non-small cell lung cancer (NSCLC) that has a specific mutation in the epidermal growth factor receptor (EGFR). The goal is to gather information from patients receiving these treatments in regular medical practice, rather than in a controlled clinical trial setting. This will help researchers better understand how safe and effective these treatments are for people with this type of lung cancer.
To participate in this study, patients need to have a confirmed diagnosis of advanced NSCLC and an EGFR mutation. They should be at least 18 years old and have not previously received treatment with osimertinib or other similar drugs. Participants will be asked to provide consent for their treatment data to be collected for analysis, but they will not be receiving any experimental treatment as part of this trial. It's important to note that this study is focused on collecting information, not on providing treatment.
Gender
ALL
Eligibility criteria
- 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.
About Precog, Llc.
Precog, LLC is a pioneering clinical trial sponsor dedicated to advancing medical research through innovative study design and execution. With a focus on enhancing patient outcomes and accelerating the development of therapeutics, Precog leverages cutting-edge technology and analytics to streamline trial processes and improve data integrity. Our team of experienced professionals collaborates closely with healthcare providers, regulatory bodies, and stakeholders to ensure compliance, optimize patient recruitment, and deliver robust results. Committed to transparency and ethical practices, Precog is at the forefront of transforming clinical research into actionable insights that benefit patients and the medical community alike.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Philadelphia, Pennsylvania, United States
Birmingham, Alabama, United States
Edina, Minnesota, United States
Waconia, Minnesota, United States
La Crosse, Wisconsin, United States
Saint Paul, Minnesota, United States
Oak Lawn, Illinois, United States
Coon Rapids, Minnesota, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Shakopee, Minnesota, United States
Willmar, Minnesota, United States
Baltimore, Maryland, United States
Hazel Crest, Illinois, United States
Pittsburgh, Pennsylvania, United States
Minneapolis, Minnesota, United States
New Brunswick, New Jersey, United States
Bronx, New York, United States
Robbinsdale, Minnesota, United States
Saint Louis Park, Minnesota, United States
Syracuse, New York, United States
Milwaukee, Wisconsin, United States
Park Ridge, Illinois, United States
Morristown, New Jersey, United States
Maplewood, Minnesota, United States
Maplewood, Minnesota, United States
Stillwater, Minnesota, United States
Jackson, Mississippi, United States
Woodbury, Minnesota, United States
Voorhees, New Jersey, United States
Troy, Ohio, United States
Sheboygan, Wisconsin, United States
Chicago, Illinois, United States
New Ulm, Minnesota, United States
Appleton, Wisconsin, United States
Warrenville, Illinois, United States
Grafton, Wisconsin, United States
Chicago, Illinois, United States
Geneva, Illinois, United States
Burlington, Wisconsin, United States
Green Bay, Wisconsin, United States
Janesville, Wisconsin, United States
Kenosha, Wisconsin, United States
Milwaukee, Wisconsin, United States
Racine, Wisconsin, United States
Summit, Wisconsin, United States
Two Rivers, Wisconsin, United States
Wauwatosa, Wisconsin, United States
Centerville, Ohio, United States
Maple Grove, Minnesota, United States
Wyoming, Minnesota, United States
Monticello, Minnesota, United States
Memphis, Tennessee, United States
Milwaukee, Wisconsin, United States
Appleton, Wisconsin, United States
Franklin, Ohio, United States
Summit, New Jersey, United States
Moorestown, New Jersey, United States
Dekalb, Illinois, United States
Oshkosh, Wisconsin, United States
Lake Forest, Illinois, United States
Burnsville, Minnesota, United States
Walnut Creek, California, United States
Jackson, Mississippi, United States
Cambridge, Minnesota, United States
Princeton, Minnesota, United States
Barrington, Illinois, United States
Cudahy, Wisconsin, United States
Paramus, New Jersey, United States
Neenah, Wisconsin, United States
New London, Wisconsin, United States
Shawano, Wisconsin, United States
Waupaca, Wisconsin, United States
Fort Smith, Arkansas, United States
Milwaukee, Wisconsin, United States
Oshkosh, Wisconsin, United States
Englewood, Ohio, United States
Dover, Delaware, United States
East Hills, New York, United States
Appleton, Wisconsin, United States
Berlin, Wisconsin, United States
West Islip, New York, United States
Orland Park, Illinois, United States
Greenville, Ohio, United States
Glenview, Illinois, United States
Grayslake, Illinois, United States
Fort Worth, Texas, United States
Waukesha, Wisconsin, United States
Fort Smith, Arkansas, United States
Joplin, Missouri, United States
Rolla, Missouri, United States
Saint Louis, Missouri, United States
Springfield, Missouri, United States
Oklahoma City, Oklahoma, United States
Dallas, Texas, United States
Minneapolis, Minnesota, United States
Saint Louis Park, Minnesota, United States
Jonesboro, Arkansas, United States
Columbus, Mississippi, United States
Grenada, Mississippi, United States
New Albany, Mississippi, United States
Oxford, Mississippi, United States
Southhaven, Mississippi, United States
Collierville, Tennessee, United States
Covington, Tennessee, United States
Memphis, Tennessee, United States
Paoli, Pennsylvania, United States
Milford, Delaware, United States
Canton, Ohio, United States
Morristown, New Jersey, United States
Milwaukee, Wisconsin, United States
Urbana, Illinois, United States
New York, New York, United States
Chicago, Illinois, United States
Hendersonville, North Carolina, United States
Germantown, Wisconsin, United States
Washington, District Of Columbia, United States
Patients applied
Trial Officials
Suzanne Cole, MD
Study Chair
UT Southwestern Simmons Comprehensive Cancer Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported