Biomarker-Guided Therapy for Refractory NSCLC

BATTLE was a randomized phase II, single-center, open-label study in patients with advanced NSCLC refractory to prior chemotherapy (Fig. 1). Following molecular tumor-biomarker assessments, patients were randomly assigned to oral treatment with erlotinib (150 mg once daily; Tarceva, OSIP/Genentech), vandetanib (300 mg once daily; Zactima, AstraZeneca), erlotinib (150 mg once daily) plus bexarotene (400 mg/m² once daily; Targretin, Eisai), or sorafenib (400 mg twice daily; Nexavar, Bayer/Onyx). The primary end point was the disease control rate (DCR) at eight weeks. Secondary end points included response rate, progression-free survival (PFS), overall survival (OS), and toxicity. Planned exploratory objectives were each treatment's efficacy in relation to patient biomarker profiles.
The Institutional Review boards of M. D. Anderson Cancer Center and the U.S. Department of Defense approved the study, which was monitored by an independent Data and Safety Monitoring Board.

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Kim E.S., Herbst R.S., Wistuba I.I., Lee J.J., Blumenschein GR J.r., Tsao A., Stewart D.J., Hicks M.E., Erasmus J J.r., Gupta S., Alden C.M., Liu S., Tang X., Khuri F.R., Tran H.T., Johnson B.E., Heymach J.V., Mao L., Fossella F., Kies M., Papadimitrakopoulou V., Davis S.E., Lippman S.M, & Hong W.K. (2011). The BATTLE Trial: Personalizing Therapy for Lung Cancer. Cancer discovery, 1(1), 44-53.

Publication 2011

Bexarotene Biomarker Cancer Chemotherapy Erlotinib Institutional review boards Nexavar Nsclc Oral treatment Patient Safety monitoring board Sorafenib Tarceva Targretin Tumor biomarker Vandetanib Zactima

Corresponding Organization :

Other organizations : The University of Texas MD Anderson Cancer Center, University of Maryland, Baltimore, Dana-Farber Cancer Institute, Emory University

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Protocol cited in 6 other protocols

Variable analysis

independent variables

Erlotinib (150 mg once daily)
Vandetanib (300 mg once daily)
Erlotinib (150 mg once daily) plus bexarotene (400 mg/m^2 once daily)
Sorafenib (400 mg twice daily)

dependent variables

Disease control rate (DCR) at eight weeks
Response rate
Progression-free survival (PFS)
Overall survival (OS)
Toxicity

control variables

Molecular tumor-biomarker assessments

Annotations

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