Prospective phase II trial evaluating efficacy of Trastuzumab therapy in HER2 FISH positive and/or HER2 mutation positive, pretreated, Non-Small Cell Lung Cancer patients (MO20509) - ND

ISTITUTO CLINICO HUMANITAS0 sitesJuly 14, 2008

Overview

No summary available.

Registry

who.int

Start Date

July 14, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ISTITUTO CLINICO HUMANITAS

•Histologically confirmed diagnosis of NSCLC. Availability of tumor tissue for HER2 FISH analysis or HER2 gene mutation analysis is mandatory
•Stage IIIB (with effusion) or stage IV or disease relapsed after surgery or radiotherapy and in any case not suitable for radiotherapy or surgery with curative intent
•HER2 FISH positive defined as high polysomy or gene amplification, or presence of HER2 gene mutation in exon 20
•At least one measurable lesion
•Patients pretreated with at least one chemotherapy regimen. Previous therapy with erlotinib or other tyrosine kinase inhibitors is allowed.
•Patients compliance to trial procedures
•Age ≥ 18 years
•Written informed consent
•Adequate BM function (ANC ≥ 1\.5x109/L, Platelets ≥ 100x109/L, HgB \> 9g/dl)
•Adequate liver function (bilirubin Normal level of alkaline phosphatase and creatinine.

•HER2 FISH negative tumor and no HER2 gene mutation
•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