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
- Conditions
- HER2 FISH POSITIVE AND/OR HER2 MUTATION POSITIVE, PRETREATED NON-SMALL CELL LUNG CANCER PATIENTSMedDRA version: 9.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IV
- Registration Number
- EUCTR2007-003709-29-IT
- Lead Sponsor
- ISTITUTO CLINICO HUMANITAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method [intrauterine contraceptive device (IUD), birth control pills, or barrier device] during and for three months after end of treatment.
ECOG performance status 0-1 and life expectancy of at least 3 months
Have recovered from the acute, reversible effects of prior surgery or radiotherapy. This means that at least 3 weeks should have elapsed since prior radiotherapy.
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
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
Treatment with any investigational drug within 30 days before the beginning of treatment with study drug.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Response rate;Main Objective: Response rate;Secondary Objective: Time to disease progression, overall survival, safety, and assessment of biomarkers potentially implicated in trastuzumab sensitivity/resistance
- Secondary Outcome Measures
Name Time Method