Lung Cancer Clinical Trial
Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)
Summary
- Progression free survival after locally ablative therapy and erlotinib in EGFR patients progressed after EGFR-TKI therapy
Full Description
Primary Objectives
- To estimate progression free survival (PFS) after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy
Secondary Objectives
To evaluate local control of sites previously progressive on erlotinib following stereotactic radiosurgery (SRS) followed by erlotinib
To estimate overall survival (OS) after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy
To characterize the toxicity of SRS
To characterize the toxicity of erlotinib when preceded by SRS
Exploratory Objectives
To explore if VeriStrat results at initial progression are associated with longer PFS or OS after study treatment
To explore if VeriStrat results following completion of SRS are associated with longer PFS or OS after re-initiation of erlotinib
To explore whether "poor" VeriStrat signatures ever turn to "good" signatures with the study therapy, and to explore PFS and OS of patients whose signature changes
Eligibility Criteria
Inclusion Criteria:
Written informed consent
18 years of age or older
Histologically or cytologically confirmed stge IV EGFR-mutant NSCLC
History of previous response to EGFR-TKI defined by a RECIST 1.1 criteria
Progressive disease following EGFR-TKI therapy
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate organ and marrow function
Negative urine or serum pregnancy test for female patients
Patients who can have children must agree to adequate contraception
Exclusion Criteria:
Unresolved chronic toxicities greater than 2, measured by CTCAE v4
Treatment with any FDA approved or experimental cancer treatment following progression on EGFR-TKI
Any history of previous greater than grade 3 toxicity attributable to erlotinib
Pregnant or lactating female
Any previous radiation to sites of planned Stereostatic Radiosurgery
History of another malignancy
Concomitant anticancer therapy, immunotherapy, or radiation therapy (within 4 weeks)
Evidence of severe or uncontrolled systemic diseases
Known hypersensitivity reaction or idiosyncrasy to erlotinib
Psychological, familial, sociological, or geographical conditions
Any other condition in investigator's opinion jeopardize compliance with protocol
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 8 Locations for this study
San Francisco California, 94115, United States
Aurora Colorado, 80045, United States
Chapel Hill North Carolina, 27599, United States
Greenville North Carolina, 27834, United States
Cleveland Ohio, 44195, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15232, United States
Seattle Washington, 98104, United States
How clear is this clinincal trial information?