Status:
TERMINATED
A Study of Nimotuzumab in Combination With External Radiotherapy in Non-Small Cell Lung Cancer
Lead Sponsor:
YM BioSciences
Collaborating Sponsors:
CIMYM BioSciences
Conditions:
Non-small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
This is a randomized, double blind, multicenter Phase II study with Phase I lead-in. Patients enrolled in this study will receive external radiotherapy with or without nimotuzumab (TheraCIM h-R3). The...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed non-small cell lung cancer.
- Patients must be suitable for palliative radiation therapy as per institutional standards.
- Stage IIB, III or IV (patients off steroids with treated, stable brain metastases are eligible).
- Patients may be symptomatic or asymptomatic from disease
- Age \>18 years
- ECOG 0-1-2
- Patients who received previous chemotherapy are allowed
- Haemoglobin \>9g/dL (blood transfusion to increase Hb level is acceptable)
- Stage II/III patients must be considered unsuitable for radical (standard full dose curative intent) chemoradiation in the opinion of either the radiotherapist or medical oncologist.
- Patients must have measurable disease in the planned radiation field.
- Women of child-bearing potential and men must agree to use adequate contraception.
- Ability to understand and the willingness to sign a written informed consent document
- Exclusion criteria - Phase I and Phase II:
- Patients receiving any other investigational agents
- Previous treatment with anti-EGF-R drug(s)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to nimotuzumab or other agents used in study.
- Prior thoracic radiotherapy for this condition
- Prior chemotherapy within 4 weeks of enrolment
- Lesions not suitable for radiotherapy
- Patients with known sero positive HIV
- Patients with uncontrolled hypercalcemia
- Patients with progressive or untreated brain metastases or treated brain metastases but unable to discontinue steroids
- 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
- Pregnant or breast-feeding women
- Any concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix; patients with other prior malignancies are eligible providing prior malignancy cannot be clinically confused with the diagnosis of NSCLC in the opinion of the treating oncologist; in particular, there should be no evidence of current disease activity with respect to the prior malignancy
- Life expectancy of less than 8 weeks
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00369447
Start Date
March 1 2009
End Date
July 1 2011
Last Update
July 1 2011
Active Locations (13)
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1
Florida Cancer Institute - New Hope
New Port Richey, Florida, United States, 34655
2
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 4N2
3
Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
4
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6