Phase II Study of Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib for Patients With Epidermal Growth Factor Receptor(EGFR) Mutation Who Have Previously Progressed on an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor (EGFR-TKI)
18 Years
N/A
Both
Non Small Cell Lung Cancer
Trial Information
Phase II Study of Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib for Patients With Epidermal Growth Factor Receptor(EGFR) Mutation Who Have Previously Progressed on an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor (EGFR-TKI)
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 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 following completion of SRS are associated with longer
PFS or OS after re-initiation of erlotinib
- To explore if VeriStat results following completion of SRS are associated with longer
PFS or OS after re-initiation of erlotinib
- To explore whether "poor" VeriStat signatures every turn to "good" signatures with the
study therapy, and to explore PFS and OS of patients whose signature changes
- To utilize the full NMR peaks from MALDI-TOF to generate hypotheses regarding
alternative signatures for evaluation and novel biomarkers
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival in EGFR-mutant after erlotinib
Outcome Description:
Progression free survival (PFS) after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy
Outcome Time Frame:
Initiation of Stereostatic Radiotherapy every 6 to 12 weeks until progression
Safety Issue:
Yes
Principal Investigator
Jared Weiss, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UNC at Chapel Hill
Authority:
United States: Food and Drug Administration
Study ID:
LCCC 1123
NCT ID:
NCT01573702
Start Date:
January 2012
Completion Date:
April 2018
Related Keywords:
- Non Small Cell Lung Cancer
- Non small cell lung cancer
- EGFR mutant
- Phase II
- erlotinib
- tarceva
- cyberknife
- Lineberger
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania 15213 |
| University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
| Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina 27599-7305 |
| East Carolina University | Greenville, North Carolina 27858 |
| STO Taussig Cancer Center; Cleveland Clinic | Cleveland, Ohio 44195 |
