Phase II study of ramucirumab and docetaxel for previously treated non-small cell lung cancer patients with malignant pleural effusion: Protocol of PLEURAM study

Thorac Cancer. 2020 Feb;11(2):389-393. doi: 10.1111/1759-7714.13279. Epub 2019 Dec 18.

Abstract

Introduction: Anti-vascular endothelial growth factor therapy has been shown to be effective in non-small cell lung cancer (NSCLC) patients with malignant pleural effusion (MPE); however, there are no data to suggest that ramucirumab has the same effects.

Methods: We therefore decided to conduct a phase II study of ramucirumab plus docetaxel for NSCLC patients with MPE. The MPE control rate at eight weeks after the start of treatment will be the primary endpoint, and the objective response rate, progression-free survival, one-year survival rate, overall survival, and toxicity profile will be secondary endpoints.

Discussion: A previous study indicated that administering chemotherapy in combination with bevacizumab was effective at controlling pleural effusion in patients with NSCLC with carcinomatous pleurisy. It is expected that ramucirumab will have a similar effect to the same group.

Keywords: NSCLC; docetaxel; pleural effusion; ramucirumab.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Monoclonal, Humanized / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / pathology
  • Clinical Trials, Phase II as Topic
  • Docetaxel / administration & dosage
  • Follow-Up Studies
  • Humans
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / pathology
  • Multicenter Studies as Topic
  • Pleural Effusion, Malignant / drug therapy*
  • Pleural Effusion, Malignant / pathology
  • Prognosis
  • Ramucirumab
  • Salvage Therapy
  • Survival Rate

Substances

  • Antibodies, Monoclonal, Humanized
  • Docetaxel