HER2 FISH POSITIVE AND/OR HER2 MUTATION POSITIVE, PRETREATED NON-SMALL CELL LUNG CANCER PATIENTS MedDRA version: 9.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV
Conditions
Interventions
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Trastuzumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Sponsors
ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed