CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 150 enrolled
Drug / intervention
Pemetrexed +1 moredrug
Likely dose
Not stated in record
Key inclusion· 8
  • Histologically or cytologically confirmed NSCLC
  • Stage IIIB/IV with progressive disease after first-line platinum-based chemotherapy (taxanes, gemcitabine, or vinorelbine)
  • At least one measurable lesion by modified WHO criteria
  • EGFR expression assessment available via archived tissue or cytology
Key exclusion· 9
  • Prior EGFR-directed therapy or EGFR signal transduction inhibitors
  • Prior treatment with pemetrexed
  • Radiotherapy or major surgery within 30 days
  • Documented or symptomatic brain metastases or leptomeningeal disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00111839
NCT00111839Phase 2Completed

Randomized, Phase II, Open-Label Controlled Study of Two Different Doses and Schedules of EMD 72000 (Matuzumab) in Combination With Pemetrexed, or Pemetrexed Alone, as Second-Line Treatment for Stage IIIB/IV Non-Small Cell Lung Cancer and Progressive Disease on or After First-Line Treatment With a Platinum in Combination With Taxanes, Gemcitabine and Vinorelbine

EMD Serono·interventional·Posted May 27, 2005·Updated Apr 6, 2018

In Brief

A Phase 2 clinical trial evaluating Pemetrexed and Matuzumab for Lung Cancer and Non Small Cell Lung Carcinoma. Completed, enrolled 150 participants across 58 sites in 3 countries.

Detailed Summary

This open-label, multicenter, randomized, controlled, Phase II study is planned to answer questions about how the drug, matuzumab (EMD 72000), works and is part of an effort aimed to develop better treatment for advanced lung cancer by combining matuzumab, a monoclonal antibody, with a chemotherapy treatment, called pemetrexed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Germany, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 27, 2005
Enrollment StartMay 31, 2005
Primary CompletionJul 31, 2007
Study CompletionMar 31, 2009
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 21.1 years ago

Interventions

Pemetrexeddrug

Pemetrexed will be administered IV until PD or the occurrence of unacceptable toxicity.

Matuzumabdrug

Matuzumab will be administered IV until PD or the occurrence of unacceptable toxicity.