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Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients
Trial Status: active
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.
Inclusion 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06538038.
Locations matching your search criteria
United States
Alabama
Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Name Not Available
California
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Approved
Name Not Available
Illinois
Chicago
Northwestern University
Status: Active
Name Not Available
New Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Name Not Available
New York
Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Name Not Available
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Status: Active
Name Not Available
Texas
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Status: Active
Name Not Available
Wisconsin
Madison
University of Wisconsin Carbone Cancer Center - University Hospital
Status: Active
Name Not Available
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.