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Open-label, Multicenter, Randomized Phase II Trial of Treatment With Cisplatin and Pemetrexed or Cisplatin and Oral Vinorelbine in Chemotherapy Naïve Patients Affected by Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer With High Thymidylate Synthase Expression

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · 2016
ClinicalTrials.gov · Datasets · License: Public Domain · 2016
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carcinomanon-small-cell-lungsecondarytreatment
This is an open-label, multicentre, randomized phase II trial. Eligible patients with Non Small Cell Lung Cancer (NSCLC) with high Thymidylate Synthase (TS) expression , will be randomly assigned with 1:1 ratio to the following treatment Arms: A. 4 cycles of Cisplatin + Oral Vinorelbine followed by maintenance with Metronomic Oral Vinorelbine until disease progression B. 4 cycles of Cisplatin + Pemetrexed followed by maintenance with Pemetrexed until disease progression Treatment will be repeated every 21 days .
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