Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutat
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
| Condition(s) | Non Small Cell Lung Cancer, Epidermal Growth Factor Receptor Gene Mutation, Stage III Lung Cancer, Stage IV Lung Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can 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 utiliz |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | PrECOG, LLC. |
| Locations | Birmingham, Alabama, United States; Fort Smith, Arkansas, United States; Fort Smith, Arkansas, United States; Jonesboro, Arkansas, United States; Emeryville, California, United States; Palo Alto, California, United States (+140 more sites) |
| Start date | 2024-09-17 |
| NCT ID | NCT06538038 |
| Official listing | https://clinicaltrials.gov/study/NCT06538038 |