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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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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 CenterPittsburgh, Pennsylvania  15213
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina  27599-7305
East Carolina UniversityGreenville, North Carolina  27858
STO Taussig Cancer Center; Cleveland ClinicCleveland, Ohio  44195