Prospective Non-Interventional Study Comparing Standard of Care Osimertinib +/- Chemotherapy for EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) Patients
PrECOG, LLC.
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 dele…
Interventions
- DrugOsimertinib
Single agent Osimertinib by mouth once daily. Dosing and administration of osimertinib will be administered as per routine standard of care per the package insert or per institutional guidelines.
- DrugOsimertinib + Chemotherapy
Osimertinib by mouth once daily + Chemotherapy. Chemotherapy choice will be per treating physician. Dosing and administration of osimertinib +/- chemotherapy agents will be administered as per routine standard of care per the package insert or per institutional guidelines.
Locations (146)
- University of Alabama at BirminghamBirmingham, Alabama
- Mercy Clinic Fort Smith CommunitiesFort Smith, Arkansas
- Mercy ResearchFort Smith, Arkansas
- Fowler Family Cancer Center - JonesboroJonesboro, Arkansas
- Stanford Cancer Center EmeryvilleEmeryville, California
- Stanford Cancer Institute Palo AltoPalo Alto, California