Open-label Study in Patients With Metastatic NSLC Treated With Cisplatin, Gemcitabine and Bevacizumab
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
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.