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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)

Phase 2
18 Years
Not Enrolling

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Trial Information

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)

Inclusion Criteria:

- • Histologically confirmed diagnosis of NSCLC. Availability of tumor tissue for HER2
FISH analysis and/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 >9 g/dl)

- Adequate liver function (bilirubin in present of liver metastases).

- 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 trial.

- 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

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

every two months

Safety Issue:


Principal Investigator

Armando Santoro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Clinico Humanitas


Italy: Ministry of Health

Study ID:




Start Date:

July 2008

Completion Date:

December 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms