Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients
Purpose
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.
Conditions
- Non Small Cell Lung Cancer
- Epidermal Growth Factor Receptor Gene Mutation
- Stage III Lung Cancer
- Stage IV Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
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.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Group 1 | Osimertinib |
|
| Group 2 | Osimertinib + Chemotherapy |
|
Recruiting Locations
Birmingham, Alabama 35294
More Details
- Status
- Recruiting
- Sponsor
- PrECOG, LLC.
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 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.