Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000571077
Ethics application status
Approved
Date submitted
30/06/2010
Date registered
16/07/2010
Date last updated
11/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase I-II Clinical Study of Nimotuzumab (TheraCIM h-R3) in Combination with External Radiotherapy in Stage IIB, III and IV Non-Small Cell Lung Cancer (NSCLC)
Scientific title
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)
Secondary ID [1] 252121 0
YMB1000-010 (YM BioSciences Incorporated study ID)
Secondary ID [2] 252122 0
NCT00369447 (ClinicalTrials.gov)
Universal Trial Number (UTN)
U1111-1115-6751
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer (NSCLC) 257665 0
Condition category
Condition code
Cancer 257845 257845 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
200 mg nimotuzumab once a week through intravenous infusion over 30 minutes + 30 Gy of radiotherapy in 10 fractions 5 days/wk during weeks 1 and 2 (up to additional 6 Gy in 2 fractions may be added following the above schedule if considered desirable by the patient’s physician). Nimotuzumab infusion starts concurrently with radiotherapy and will continue weekly until disease progression at the discretion of the physician.
Intervention code [1] 256734 0
Treatment: Drugs
Intervention code [2] 256777 0
Treatment: Other
Comparator / control treatment
Placebo (saline infusion) once a week + 30 Gy of radiotherapy in 10 fractions 5 days/wk during weeks 1 and 2 (up to additional 6 Gy in 2 fractions may be added following the above schedule if considered desirable by the patient’s physician). Placebo infusion will continue weekly until disease progression at the discretion of the physician.
Control group
Placebo

Outcomes
Primary outcome [1] 258706 0
Overall Survival using telephone follow-up calls.
Timepoint [1] 258706 0
After coming off protocol therapy the patient will be followed every 3 months for a year.
Secondary outcome [1] 264733 0
The local and overall response rates measured by Magnetic resonance imaging (MRI) and Computed Tomography (CT)
Timepoint [1] 264733 0
every 8 weeks from randomization to disease progression
Secondary outcome [2] 264734 0
Quality of life in patients receiving nimotuzumab in combination with radiation compared to radiation alone using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire.
Timepoint [2] 264734 0
Pre-study, week 4, week 8 and every 8 weeks thereafter until disease progression

Eligibility
Key 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.
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients will be assessed to comply with all the inclusion and exclusion criteria. Once there is confirmation of eligibility the patient will be registered. Once registred, the patient will be randomized 1:1 fashion ramdomly through an online system to receive palliative radiation in combination with nimotuzumab (experimental arm) or palliative radiation in combination with placebo (control arm), until disease progression, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first. This allocation is concealed to the physician, the patient and also the sponsor of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomized online using an internet-based Electronic Data Capture (EDC) system. In order to randomize a subject, authorized users of the database must successfully complete the Subject Registration/Randomization form containing all inclusion/exclusion criteria (Yes/No), stratification variables and the date of informed consent.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment outside Australia
Country [1] 2729 0
Canada
State/province [1] 2729 0
Alberta
Country [2] 2730 0
Canada
State/province [2] 2730 0
Ontario
Country [3] 2731 0
Canada
State/province [3] 2731 0
Quebec
Country [4] 2732 0
Canada
State/province [4] 2732 0
New Foundland
Country [5] 2733 0
Canada
State/province [5] 2733 0
British Columbia
Country [6] 2734 0
Singapore
State/province [6] 2734 0
Singapore
Country [7] 2735 0
Korea, Republic Of
State/province [7] 2735 0
Seoul
Country [8] 2736 0
United States of America
State/province [8] 2736 0
Florida

Funding & Sponsors
Funding source category [1] 257217 0
Commercial sector/Industry
Name [1] 257217 0
YM BioSciences Inc.
Country [1] 257217 0
Canada
Primary sponsor type
Commercial sector/Industry
Name
YM BioSciences Inc.
Address
5045 Orbitor Drive
Building 11, Suite 400
Mississauga, Ontario
Canada L4W 4Y4
Country
Canada
Secondary sponsor category [1] 256468 0
None
Name [1] 256468 0
Address [1] 256468 0
Country [1] 256468 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259240 0
Conjoint Health Research Ethics Board
Ethics committee address [1] 259240 0
Office of Medical Bioethics
Room 93, Heritage Medical Research Bldg
3330 Hospital Drive NW
Calgary, AB, Canada T2N 4N1
Ethics committee country [1] 259240 0
Canada
Date submitted for ethics approval [1] 259240 0
Approval date [1] 259240 0
19/02/2009
Ethics approval number [1] 259240 0

Summary
Brief summary
This study looks at the effectiveness of nimotuzumab (TheraCIM h-R3) in combination with external radiotherapy in treating non-small cell lung cancer (NSCLC) at stage IIB, III and IV.

Who is it for?
You can join this study if you have non-small cell lung cancer which is suitable for palliative radiation therapy, and is at stage IIB, III or IV.

Trial details
Participants will be divided into two groups. One group will receive 200 mg nimotuzumab in addition to 2 weeks' standard radiation. The second group will receive a non-active compound (placebo) plus standard radiation.
Despite aggressive surgical and chemotherapeutic interventions, non-small cell lung cancer is the leading cause of cancer-related death in men and women, with overall cure rates of less than 15%. Nimotuzumab is a novel therapy which may offer new hope.
Trial website
Trial related presentations / publications
Bebb G, Brade A, Smith C, Rorke S, Sherman I. Preliminary results of an escalating dose phase I clinical trial of the anti-EGFR monoclonal antibody nimotuzumab in combination with external radiotherapy in patients diagnosed with stage IIb, III or IV non-small cell lung cancer unsuitable for radical therapy. 2008 (ASCO abstract 3037).
Public notes

Contacts
Principal investigator
Name 31348 0
Address 31348 0
Country 31348 0
Phone 31348 0
Fax 31348 0
Email 31348 0
Contact person for public queries
Name 14595 0
Wendy Chapman
Address 14595 0
5045 Orbitor Drive Building 11, Suite 400 Mississauga, Ontario, Canada L4W 4Y4
Country 14595 0
Canada
Phone 14595 0
+1 905 629 9761
Fax 14595 0
+1 905 629 4959
Email 14595 0
wchapman@ymbiosciences.com
Contact person for scientific queries
Name 5523 0
Dr Mark Kowalski
Address 5523 0
5045 Orbitor Drive
Building 11, Suite 400
Mississauga, Ontario
Canada L4W 4Y4
Country 5523 0
Canada
Phone 5523 0
+1 905 629 9761
Fax 5523 0
+1 905 629 4959
Email 5523 0
mkowalski@ymbiosciences.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.