Clinical trial NCT00758134 (phase 2, status: terminated)
Conditions: non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: trastuzumab (herceptin)
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    insufficient accrual
  
Eligibility criteria:

        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 <G2, transaminases no more than 3xULN/<5xULN
                  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
                  radiotherapy.

        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.