Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients
- Registration Number
- NCT06538038
- Lead Sponsor
- PrECOG, LLC.
- Brief 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.
- Detailed 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 t...
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 538
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Osimertinib Osimertinib Group 2 Osimertinib + Chemotherapy Osimertinib + Chemotherapy
- Primary Outcome Measures
Name Time Method real-world Progression-Free Survival (rwPFS) From initiation of therapy to progression or death, up to 3 years Time from initiating therapy to progression or death without documented progression
- Secondary Outcome Measures
Name Time Method real-world Overall Survival (rwOS) From initiation of therapy to death, up to 3 years Time from initial therapy to death from any cause.
real-world time to treatment discontinuation (rwTTD) From initiation of therapy to discontinuation of osimertinib, up to 3 years Time from treatment initiation (osimertinib or osimertinib + chemotherapy) to discontinuation of osimertinib.
Trial Locations
- Locations (12)
Mercy Clinic Cancer and Hematology
🇺🇸Rolla, Missouri, United States
Mercy Clinic East Communities
🇺🇸Saint Louis, Missouri, United States
Mercy Clinic Fort Smith Communities
🇺🇸Fort Smith, Arkansas, United States
Mercy Research
🇺🇸Fort Smith, Arkansas, United States
Mercy Clinic Joplin, LLC
🇺🇸Joplin, Missouri, United States
Mercy Clinic Springfield Communities
🇺🇸Springfield, Missouri, United States
Mercy Clinic Oklahoma Communities, Inc.
🇺🇸Oklahoma City, Oklahoma, United States
John Muir Health
🇺🇸Walnut Creek, California, United States
Miami Valley Hospital North
🇺🇸Englewood, Ohio, United States
JPS Oncology & Infusion Center
🇺🇸Fort Worth, Texas, United States
Mercyhealth Hospital and Cancer Center - Janesville
🇺🇸Janesville, Wisconsin, United States
ProHealth
🇺🇸Waukesha, Wisconsin, United States