Lung Cancer
PrE1702
Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients
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: - 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.
United States
AL
Birmingham
University of Alabama at Birmingham Cancer Center
CA
Palo Alto
Stanford Cancer Institute Palo Alto
NJ
New Brunswick
Rutgers Cancer Institute of New Jersey
NY
Bronx
Montefiore Medical Center-Weiler Hospital
PA
Philadelphia
University of Pennsylvania/Abramson Cancer Center
TX
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
WI
Madison
University of Wisconsin Carbone Cancer Center - University Hospital
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.
Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.
The ECOG-ACRIN Cancer Research Group and PrECOG, LLC designed this trial and are conducting it through a grant from the US Food and Drug Administration.


