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A Phase I-II Clinical Study of Nimotuzumab (TheraCIM h-R3) in Combination With External Radiotherapy in Stage IIB, III and IV NSCLC

Phase 1/Phase 2
18 Years
Not Enrolling
Non-small-cell Lung Cancer

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Trial Information

A Phase I-II Clinical Study of Nimotuzumab (TheraCIM h-R3) in Combination With External Radiotherapy in Stage IIB, III and IV NSCLC

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 objective of the Phase I component 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 (curative intent
chemoradiation) and to select the optimal biologically effective dose (BED) for Phase II
component of the study. In the Phase II component, overall survival, local and systemic
response rates and quality of life will be evaluated inpatients treated with nimotuzumab in
combination with palliative radiation vs. radiation alone.

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

Inclusion Criteria

1. Patients must have histologically or cytologically confirmed non-small cell lung

2. Patients must be suitable for palliative radiation therapy as per institutional

3. Stage IIB, III or IV (patients off steroids with treated, stable brain metastases are

4. Patients may be symptomatic or asymptomatic from disease

5. Age >18 years

6. 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) chemoradiation in the opinion of either the radiotherapist or
medical oncologist.

10. Patients must have measurable disease in the planned radiation field.

11. Women of child-bearing potential and men must agree to use adequate contraception.

12. Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria - Phase I and Phase II:

1. Patients receiving any other investigational agents

2. Previous treatment with anti-EGF-R drug(s)

3. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to nimotuzumab or other agents used in study.

4. Prior thoracic radiotherapy for this condition

5. Prior chemotherapy within 4 weeks of enrolment

6. Lesions not suitable for radiotherapy

7. Patients with known sero positive 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

11. Pregnant or breast-feeding women

12. 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

13. Life expectancy of less than 8 weeks

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Phase II: Overall survival

Outcome Time Frame:

Every 8 weeks until disease progression

Safety Issue:


Principal Investigator

Gwyn Bebb, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tom Baker Cancer Center


Canada: Health Canada

Study ID:




Start Date:

March 2009

Completion Date:

July 2011

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • Non small cell lung cancer
  • Nimotuzumab
  • TheraCIM
  • h-R3
  • YM BioSciences
  • Radiation
  • Non small cell lung cancer, Stage IIb, III and IV
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Florida Cancer Institute - New Hope New Port Richey, Florida  34655