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

Non-small-cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00369447
• Other study ID #: YMB1000-010
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: August 24, 2006
• Last updated: June 30, 2011
• Start date: March 2009
• Est. completion date: July 2011

Study information

• Verified date: June 2011
• Source: YM BioSciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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 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 closed to recruitment.

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 closed to recruitment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

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

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center	Calgary	Alberta
Canada	Cancer Centre for the Southern Interior	Kelowna	British Columbia
Canada	London Regional Cancer Center	London	Ontario
Canada	Centre Hospitalier de L'Universite de Montreal - Hôpital Notre Dame	Montreal	Quebec
Canada	Hopital Maisonneuve-Rosemont	Montreal	Quebec
Canada	Segal Cancer Center - Jewish General Hospital	Montreal	Quebec
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario
Canada	Hotel Dieu Hospital	Quebec City	Quebec
Canada	Dr. H. Bliss Murphy Cancer Centre	St. John's	Newfoundland and Labrador
Canada	Thunderbay Regional hospital Center	Thunderbay	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Singapore	National Cancer Center Singapore	Singapore
United States	Florida Cancer Institute - New Hope	New Port Richey	Florida

Sponsors (2)

Lead Sponsor	Collaborator
YM BioSciences	CIMYM BioSciences

Countries where clinical trial is conducted

United States,  Canada,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase II: Overall survival		Every 8 weeks until disease progression	Yes
Secondary	Phase I: Biologically effective dose		2.5 Years	Yes
Secondary	Phase II: Overall response rate		Every 8 weeks until disease progression	No
Secondary	Local response rate		Every 8 weeks until disease progression	No
Secondary	Overall clinical benefit		Every 8 weeks until disease progression	No
Secondary	Local clinical benefit		Every 8 weeks until disease progression	No
Secondary	Time to progression		Every 8 weeks until disease progression	No
Secondary	Time to local progression		Every 8 weeks until disease progression	No
Secondary	Progression-free survival		1 year	No
Secondary	Phase II: Quality of life		At week 4, week 8, every 2 months thereafter	No