NCT01573702

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	Stereotactic Radiosurgery	21 Gy daily for 5 days
DRUG	Erlotinib	150mg once daily

Timeline

• Start date: 2012-12-11
• Primary completion: 2019-03-15
• Completion: 2019-03-15
• First posted: 2012-04-09
• Last updated: 2021-01-12
• Results posted: 2021-01-12

Locations

8 sites across 1 country: United States