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

Inclusion Criteria:

- Providing a written informed consent (see Appendix A);

- Age ≥18 years;

- Histologic or cytologic confirmed diagnosis of NSCLC of any epithelial type
(squamous, adenocarcinoma, large cell, or other);

- At least one newly diagnosed measurable metastatic lesion from NSCLC in the brain;

- Patient had initial diagnosis of brain metastases by image, within 8 weeks of
registration

- KPS ≥70;

- Absolute neutrophil count ≥ 1500/mm³;

- Platelet count ≥ 50,000/mm³;

- Serum creatinine ≤2.0 mg/dL;

- Serum transaminases ≤2 x the upper limit of normal (ULN);

- Total serum bilirubin ≤2 x ULN;

- And a lactate dehydrogenase (LDH) level ≤1.3 x ULN.

Exclusion Criteria:

- Pregnancy, lactation or parturition within the previous 30 days (fertile female or
male patients should practice contraception);

- Prior WBRT, brain metastases resection with no other measurable lesion remaining;

- Extracranial metastases in two or more organs;

- Known leptomeningeal or subarachnoid tumor spread;

- Plan to use radiosurgery or radiation boost after completion of WBRT;

- Plan to use chemotherapy or any other systemic antineoplastic modality during WBRT;

- Previous use of an anti-EGFR drug;

- Participation in another ongoing therapeutic trial;

- Presence of known HIV seropositivity, 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);

- Hypersensitivity or allergy to any of the drugs to be administered in this study;

- Inability or unwillingness to complete the required assessments;

- Geographic inaccessibility for treatment or follow-up evaluations.