A Study of Nimotuzumab in Combination With Radiation Therapy in Patients With Brain Metastases from Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Recruiting

• Conditions: on-Small Cell Lung Cancer with brain metastases; Non-Small Cell Lung Cancer with brain metastases; Cancer - Lung - Non small cell; Cancer - Brain

• Registration Number: ACTRN12610000560099
• Lead Sponsor: YM BioSciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1.Providing a written informed consent
2.Age >=18 years;
3.Histologic or cytologic confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) of any epithelial type (squamous, adenocarcinoma, large cell, or other);
4.At least one newly diagnosed measurable metastatic lesion from NSCLC in the brain not suitable for surgical resection
5.Patient had initial diagnosis of brain metastases by image, within 8 weeks of registration
6.Karnofsky performance status (KPS) >=70;
7.Absolute neutrophil count >= 1500/mm^3;
8.Platelet count >= 50,000/mm^3;
9.Serum creatinine <=2.0 mg/dL;
10.Serum transaminases <=2 x the upper limit of normal (ULN);
11.Total serum bilirubin <=2 x ULN;
12.Lactate dehydrogenase (LDH) level <=1.3 x ULN.
13.Women of childbearing potential and men must agree to use adequate contraception (hormonal, or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician immediately

Exclusion Criteria

1.Pregnancy, lactation or parturition within the previous 30 days.
2.Previous WBRT.
3.Brain metastases resection with no other measurable lesion remaining.
4.Extracranial metastases in two or more organs.
5.Known leptomeningeal or subarachnoid tumor spread.
6.Plan to use radiosurgery or radiation boost after completion of WBRT.
7.Plan to use chemotherapy or any other antineoplastic modality during WBRT.
8.Previous use of an anti-EGFR drug (e.g. Tarceva, Erbitux etc.).
9.Patients receiving any other investigational agents.
10.Presence of known seropositive Human immunodeficiency virus (HIV).
11.Severe comorbidities, or other malignant neoplasm within 5 years (except adequately treated basal- or squamous-cell carcinoma of skin or in situ carcinoma of the uterine cervix).
12.Hypersensitivity or allergy to any of the drugs to be administered in this study.
13.Inability or unwillingness to complete the required assessments.
14.Geographic inaccessibility for treatment or follow-up evaluations.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intracranial Disease progression over 6 months using magnetic resonance imaging (MRI)[at 6 months following randomization]

Secondary Outcome Measures

Name	Time	Method
Overall survival using telephone follow-ups[Every 3 months for upto 12 months after patient came off study.];To assess progression of intercranial disease at 2, 4 and 6 months using MRI[2, 4 and 6 months following randomisation];Time to neurologic progression (TNP) or death using MRI and Mini-Mental Status Examination (MMSE)[Every 8 weeks from randomization to disease progression];Overall survival at 6 months using medical records or telephone follow-ups.[6 months following randomisation];Intracranial disease progression using MRI[Every 8 weeks from randomization to disease progression];Time to overall disease progression using Magnetic resonance imaging (MRI) and Computed Tomography (CT)[Every 8 weeks from randomization to disease progression]