Open-label Study in Patients With Metastatic NSLC Treated With Cisplatin, Gemcitabine and Bevacizumab

Summary

RATIONALE: Classically the evaluation of response in lung cancer has been based in comparing pre \& post treatment tumour volume by means of studying changes in the diameter of the selected target lesions by RECIST. The introduction of new targeted drugs creates the need of a different response assessment. Functional imaging techniques are able to study in vivo physiological processes of angiogenesis. Therefore, dynamic techniques may be more appropriate for assessing response to antiangiogenic drugs, whose mechanism of action is focused on tumor's vasculature normalization. Preliminary studies have demonstrated significant and very early changes in indirect vasculature parameters such as flow, blood volume and tumor perfusion with vascular-targeting agents. These techniques may be useful for selecting patients who are going to benefit from antiangiogenic therapy by an early evaluation of response by means of functional imaging method. PURPOSE: IMPACT is an open-label, single arm phase II/IV study to evaluate the predictive value and early radiologic response or perfusion computed tomography (CT) in patients diagnosed with unresectable advanced, metastatic or recurrent non-squamous NSCLC treated with bevacizumab in combination with chemotherapy.

Timeline

Start

2013-07

Primary completion

2016-09

Completion

2016-10

Publications

• Background Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884.
• Background Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C. Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil. J Clin Oncol. 2009 Mar 10;27(8):1227-34. doi: 10.1200/JCO.2007.14.5466. Epub 2009 Feb 2.
• Background Tacelli N, Remy-Jardin M, Copin MC, Scherpereel A, Mensier E, Jaillard S, Lafitte JJ, Klotz E, Duhamel A, Remy J. Assessment of non-small cell lung cancer perfusion: pathologic-CT correlation in 15 patients. Radiology. 2010 Dec;257(3):863-71. doi: 10.1148/radiol.10100181. Epub 2010 Sep 15.
• Background Fraioli F, Vetere S, Anile M, Venuta F. Computed tomography perfusion: a new method to evaluate response to therapy in lung cancer. J Thorac Oncol. 2011 Sep;6(9):1599-600. doi: 10.1097/JTO.0b013e3182259207. No abstract available.
• Background Tacelli N, Santangelo T, Scherpereel A, Duhamel A, Deken V, Klotz E, Cortot A, Lafitte JJ, Wallyn F, Remy J, Remy-Jardin M. Perfusion CT allows prediction of therapy response in non-small cell lung cancer treated with conventional and anti-angiogenic chemotherapy. Eur Radiol. 2013 Aug;23(8):2127-36. doi: 10.1007/s00330-013-2821-2. Epub 2013 Apr 4.
• Background Yuan X, Zhang J, Quan C, Cao J, Ao G, Tian Y, Li H. Differentiation of malignant and benign pulmonary nodules with first-pass dual-input perfusion CT. Eur Radiol. 2013 Sep;23(9):2469-74. doi: 10.1007/s00330-013-2842-x. Epub 2013 Jun 22.

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Indications