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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-11

Study Completion Date

2019-03-15

Brief Summary

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\- Progression free survival after locally ablative therapy and erlotinib in EGFR patients progressed after EGFR-TKI therapy

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Detailed Description

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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

Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

For all patients, all sites of progressive disease will be treated with local ablation (primarily stereotactic radiosurgery) followed by the EGFR-TKI erlotinib until disease progression.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stereotactic Radiosurgery Followed by Erlotinib

Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib

Group Type OTHER

Stereotactic Radiosurgery

Intervention Type PROCEDURE

21 Gy daily for 5 days

Erlotinib

Intervention Type DRUG

150mg once daily

Interventions

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Stereotactic Radiosurgery

21 Gy daily for 5 days

Intervention Type PROCEDURE

Erlotinib

150mg once daily

Intervention Type DRUG

Other Intervention Names

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Cyberknife Tarceva

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No