None listed
Conditions
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.
Interventions
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.
Sponsors
YM BioSciences Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed