A Randomized, Phase II, Double-Blind Study of Nimotuzumab Plus Whole-Brain Radiation Therapy (WBRT) Compared with WBRT Alone in Patients with Brain Metastases from Non-Small Cell Lung Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019637-96-DE

Enrollment

Registered

2010-10-01

Start date

2010-12-20

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain metastases from Non-Small Cell Lung Cancer (NSCLC)

Interventions

Product Name: h-R3, OSAG101 Product Code: h-R3, OSAG101 Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: In

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Providing written informed consent Age >|18 years hystologic or cytologic confirmed diagnoses of NSCLC of any epithelial type At least one newly diagnosed measurable metastatic lesion from NSCLC in the brain not suitable for surgical resection Patient had initial diagnosis of brain metastases by image, within 8 weeks of registration Women of childbearing potential and men must agree to use adequate contraception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy, lactation or parturition within the previous 30 days Previous WBRT Brain metastases resection with no other measurable lesion remaining Extracranial metastases in >| 2 organs Known leptomeningeal or subarachnoid spread Plan to use radiosurgery or radiation boost after completion of WBRT Plan to use chemotherapy or any other antineoplastic modality during WBRT Previous use of an anti-EGFR drug (e.g. Tarceva, Erbitux etc.) Patients receiving any other investigational agents

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the efficacy of Nimotuzumab in combination with WBRT.;Secondary Objective: Overall survival progression of intracranial disease at 2, 4 and 6 months TNP or death with evidence of neurologic progression OS rate at 6 months time to intracranial disease progression time to overall progression;Primary end point(s): The primary endpoint is intracranial disease progression at 6 months	—

Measure

Time frame

Main Objective: The primary objective is to assess the efficacy of Nimotuzumab in combination with WBRT.;Secondary Objective: Overall survival progression of intracranial disease at 2, 4 and 6 months TNP or death with evidence of neurologic progression OS rate at 6 months time to intracranial disease progression time to overall progression;Primary end point(s): The primary endpoint is intracranial disease progression at 6 months

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026