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A Study of Nimotuzumab in Combination With External Radiotherapy in Non-Small Cell Lung Cancer

NCT00369447 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2011-07-01

No results posted yet for this study

Summary

This is a Phase I-II study designed to investigate nimotuzumab (TheraCIM h-R3) in combination with external radiation in patients with non-small cell lung cancer. The purpose of the Phase I portion of the study is to evaluate the safety and feasibility of the administration of nimotuzumab with palliative radiation in patients who are unsuitable for radical therapy and to select the optimal dose for the Phase II component of the study. The primary objective for the Phase II portion of the study is to examine the efficacy of this combination treatment.

The Phase I component of this study has been completed. The Phase II is now closed to recruitment.

Conditions

  • Non-small-cell Lung Cancer

Interventions

PROCEDURE

External radiotherapy

Radiotherapy for first 2 weeks, 10 daily fractions of 30Gy 2 additional fractions to be added if desirable

BIOLOGICAL

nimotuzumab

weekly dose until disease progression

Sponsors & Collaborators

  • CIMYM BioSciences

    collaborator OTHER

  • YM BioSciences

    lead INDUSTRY

Principal Investigators

  • Gwyn Bebb, MD · Tom Baker Cancer Center

  • Anthony Brade, MD · Princess Margaret Hospital, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-06-30
Completion
2011-07-31

Countries

  • United States
  • Canada
  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00369447 on ClinicalTrials.gov