Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients
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.
Checked against the public recordLast updated Mar 27, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- PrECOG, LLC.
- Interventions being studied
- Drug: Osimertinib; Drug: Osimertinib + Chemotherapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- 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
- Stanford Cancer Center South BaySan Jose, California
- John Muir HealthWalnut Creek, California
- BayhealthDover, Delaware
- Satellite of Bayhealth SussexMilford, Delaware
- Sibley Johns Hopkins UniversityWashington D.C., District of Columbia
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: Liberty County Cancer CareHinesville, Georgia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 27, 2026. Always confirm current availability with the study team.