Lung Cancer
PrE1702
Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients
STATUS: ACTIVE
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 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. Patient Reported Outcomes (PROs) will be done 1-3 times per 15 week data capture period.
Eligibility 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.
- Patient must not have received any prior treatment with an EGFR TKI agent. 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. Patient must not be participating in EA5182 or any other treatment trial. Osimertinib +/- chemotherapy must be given as first-line treatment and 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.
- Patient must have the ability to understand and willingness to sign IRB-approved consent for data collection and study-related analyses. This is not a treatment trial.
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.
