Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients

Recruiting now

Conditions studied: Non Small Cell Lung Cancer, Epidermal Growth Factor Receptor Gene Mutation, Stage III Lung Cancer, Stage IV Lung Cancer

In brief

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.

Key facts

Study ID

NCT06538038

Run by

PrECOG, LLC.

People needed

538

Starts

2024-09-17

Expected to finish

2029-08-01

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

• Mercy Clinic Fort Smith Communities — Fort Smith, Arkansas, United States (enrolling)
• Mercy Research — Fort Smith, Arkansas, United States (enrolling)
• Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States (enrolling)
• Stanford Cancer Center Emeryville — Emeryville, California, United States (enrolling)
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States (enrolling)
• Stanford Cancer Center South Bay — San Jose, California, United States (enrolling)
• John Muir Health — Walnut Creek, California, United States (enrolling)
• Bayhealth — Dover, Delaware, United States (enrolling)
• Satellite of Bayhealth Sussex — Milford, Delaware, United States (enrolling)
• Sibley Johns Hopkins University — Washington D.C., District of Columbia, United States (enrolling)
• Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: Liberty County Cancer Care — Hinesville, Georgia, United States (enrolling)
• Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: Regional Cancer Care — Jesup, Georgia, United States (enrolling)
• Lewis Cancer and Research Pavilion at Saint Joseph's/Candler — Savannah, Georgia, United States (enrolling)
• Advocate Good Shepherd Hospital — Barrington, Illinois, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• John H Stroger Jr Hospital of Cook County — Chicago, Illinois, United States (enrolling)
• Advocate Illinois Masonic Medical Center — Chicago, Illinois, United States (enrolling)
• Northwestern Medicine Cancer Center Kishwaukee — DeKalb, Illinois, United States (enrolling)
• Northwestern Medicine Cancer Center Delnor — Geneva, Illinois, United States (enrolling)
• Northwestern Medicine Glenview Outpatient Center — Glenview, Illinois, United States (enrolling)
• Northwestern Medicine Grayslake Outpatient Center — Grayslake, Illinois, United States (enrolling)
• Advocate South Suburban Hospital — Hazel Crest, Illinois, United States (enrolling)
• Northwestern Medicine Lake Forest Hospital — Lake Forest, Illinois, United States (enrolling)
• Carle Cancer Institute Normal — Normal, Illinois, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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