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

Sponsors and Collaborators:	YM BioSciences CIMYM BioSciences
Information provided by:	YM BioSciences
ClinicalTrials.gov Identifier:	NCT00369447

Purpose

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 open for recruitment.

Condition	Intervention	Phase
Non-Small-Cell Lung Cancer	Procedure: External radiotherapy Biological: nimotuzumab	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase I-II Clinical Study of Nimotuzumab (TheraCIM h-R3) in Combination With External Radiotherapy in Stage IIB, III and IV NSCLC

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy

U.S. FDA Resources

Further study details as provided by YM BioSciences:

Primary Outcome Measures:

Phase II: Overall survival [ Time Frame: Every 8 weeks until disease progression ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Phase I: Biologically effective dose [ Time Frame: 2.5 Years ] [ Designated as safety issue: Yes ]
Phase II: Overall response rate [ Time Frame: Every 8 weeks until disease progression ] [ Designated as safety issue: No ]
Local response rate [ Time Frame: Every 8 weeks until disease progression ] [ Designated as safety issue: No ]
Overall clinical benefit [ Time Frame: Every 8 weeks until disease progression ] [ Designated as safety issue: No ]
Local clinical benefit [ Time Frame: Every 8 weeks until disease progression ] [ Designated as safety issue: No ]
Time to progression [ Time Frame: Every 8 weeks until disease progression ] [ Designated as safety issue: No ]
Time to local progression [ Time Frame: Every 8 weeks until disease progression ] [ Designated as safety issue: No ]
Progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Phase II: Quality of life [ Time Frame: At week 4, week 8, every 2 months thereafter ] [ Designated as safety issue: No ]

Estimated Enrollment:	128
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 200 mg dose	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
2: Placebo Comparator	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

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 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 open for recruitment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369447

Contacts

Contact: Leonardo Viana, MD

905 629 9761

Locations

Canada, Alberta
Tom Baker Cancer Center	Recruiting
Calgary, Alberta, Canada
Canada, Ontario
Princess Margaret Hospital	Not yet recruiting
Toronto, Ontario, Canada

Sponsors and Collaborators

YM BioSciences

CIMYM BioSciences

Investigators

Principal Investigator:	Gwyn Bebb, MD	Tom Baker Cancer Center
Principal Investigator:	Anthony Brade, MD	Princess Margaret Hospital, Canada

More Information

No publications provided

Responsible Party:	YM BioSciences ( Director, Clinical Research )
Study ID Numbers:	YMB1000-010
Study First Received:	August 24, 2006
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00369447 History of Changes
Health Authority:	Canada: Health Canada; Canada: Ethics Review Committee

Keywords provided by YM BioSciences:

Non small cell lung cancer
NSCLC
Nimotuzumab
TheraCIM

h-R3
YM BioSciences
Radiation
Non small cell lung cancer, Stage IIb, III and IV

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on August 12, 2009