Trastuzumab Therapy in Non-Small Cell Lung Cancer Patients

Exclusion Criteria

• •• HER2 FISH negative tumor and no evidence of HER2 gene mutation in exon 20
• •* Concomitant radiotherapy
• •* Untreated brain metastases or leptomeningeal disease involvement.
• •* All disease sites previously included in radiotherapy fields. If all sites were included in radiotherapy fields patient is eligible only if there is evidence of progressive disease after completion of radiotherapy.
• •* No measurable lesion
• •* Left ventricular ejection fraction (FEV) \<50%
• •* Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uteri and squamous cell carcinoma of the skin
• •* Any previous HER2 blocking therapy. Previous therapy with anti EGFR agents is allowed
• •* Pregnancy or lactating
• •* Other serious illness or medical condition including: Congestive heart failure (NYHA class II, III, IV) or history of documented congestive heart failure, unstable angina pectoris, myocardial infarction in the last 12 months, poorly controlled hypertension (systolic \>180 mmHg or diastolic \>100 mmHg), clinically significant valvular heart disease, or high-risk uncontrolled arrhythmias. Patients with dyspnoea at rest due to malignant or other disease (e.g. pulmonary metastases with lymphangitis) or who require supportive oxygen therapy. Active serious uncontrolled infections. Poorly controlled diabetes mellitus
• •* Treatment with any investigational drug within 30 days before the beginning of treatment with study drug.