Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)

UNC Lineberger Comprehensive Cancer Center

Status and phase: Completed; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Erlotinib; Procedure: Stereotactic Radiosurgery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01573702

LCCC 1123

Details and patient eligibility

About

• 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

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Stereotactic Radiosurgery Followed by Erlotinib

Other group

Description:

Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib

Treatment:

Procedure: Stereotactic Radiosurgery

Drug: Erlotinib