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Clinical Trials/ACTRN12610000571077
ACTRN12610000571077
Recruiting
Phase 2

A Phase I-II Clinical Study to evaluate the effect of Nimotuzumab (TheraCIM h-R3) in Combination with External Radiotherapy on overall survival in patients with Stage IIB, III or IV Non-Small Cell Lung Cancer (NSCLC)

YM BioSciences Inc.0 sites128 target enrollmentJuly 16, 2010
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
YM BioSciences Inc.
Enrollment
128
Status
Recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 16, 2010
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Patients must have histologically or cytologically confirmed non\-small cell lung cancer (NSCLC).
  • •2\.Patients must be suitable for palliative radiation therapy to lung disease as per institutional standards.
  • •3\.Stage IIB, III or IV (patients off steroids for a minimum of 4 weeks with no evidence of symptomatic neurologic progression with treated, stable brain metastases are eligible).
  • •4\.Patients may be symptomatic or asymptomatic from disease.
  • •5\.Age \>18 years.
  • •6\.Eastern Cooperative Oncology Group Performance Status (ECOG): 0\-1\-2\.
  • •7\.Patients who received previous chemotherapy are allowed.
  • •8\.Haemoglobin \>9g/dL (blood transfusion to increase Hb level is acceptable).
  • •9\.Stage II/III patients must be considered unsuitable for radical (standard full dose curative intent) radiation/chemoradiation in the opinion of either the radiotherapist or medical oncologist (with reasons documented).
  • •10\.Patients must have measurable disease in the planned radiation field.

Exclusion Criteria

  • •1\. Patients receiving any other investigational agents.
  • •2\. Previous treatment with anti\-Epidermal growth factor receptor (EGF\-R) drug(s) (e.g. Tarceva, Erbitux, etc).
  • •3\. History of allergic reactions attributed to compounds of similar chemical or biologic composition to nimotuzumab or other agents used in study.
  • •4\. Previously treated with thoracic radiotherapy at any time after the diagnosis.
  • •5\. Prior chemotherapy within 4 weeks of enrolment.
  • •6\. Lesions not suitable for radiotherapy.
  • •7\. Patients with known sero positive Human immunodeficiency virus (HIV).
  • •8\. Patients with uncontrolled hypercalcemia.
  • •9\. Patients with progressive or untreated brain metastases or treated brain metastases but unable to discontinue steroids.
  • •10\. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, severe cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the investigator.

Outcomes

Primary Outcomes

Not specified

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