Efficacy and Safety of BI 2536 in Advanced or Metastatic Non Small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: BI 2536
Intervention description: Intravenous Infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The trial will be performed to evaluate whether BI 2536 may be effective in the treatment of
      advanced or metastatic NSCLC of stage IIIB or IV in patients who relapsed after or failed
      first-line therapy. A secondary aim is to identify the most suitable dosage schedule for the
      further Phase II and III clinical programme of BI 2536. To achieve this objective two dosage
      schedules are compared.
    

Eligibility criteria:

        Inclusion Criteria:

        male or female patients aged 18 years or older with histologically or cytologically
        confirmed advanced or metastatic NSCLC of stage IIIB or IV, who relapsed or failed prior
        first-line chemotherapy for advanced or metastatic disease. At least one tumour lesion must
        be present that can accurately be measured by magnetic resonance imaging (MRI), or computed
        tomography (CT) in at least one dimension (longest diameter to be recorded) as 20 mm or
        greater with conventional techniques or as 10 mm or greater with spiral CT scan. Life
        expectancy of at least three months; Eastern co-operative oncology group (ECOG) performance
        score of 2 or less and written informed consent which must be consistent with international
        conference on harmonisation good clinical practice (ICH-GCP) and local legislation

        Exclusion Criteria:

        persistence of toxicities of prior anti cancer therapies which are deemed to be clinically
        relevant, known secondary malignancy requiring therapy, brain metastases which are
        symptomatic or require therapy, absolute neutrophil count less than 1,500/mm3, platelet
        count less than 100,000/mm3, haemoglobin less than 9 mg/dl, aspartate amino transferase
        (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal,
        or AST or ALT greater than 5 times the upper limit of normal in case of known liver
        metastases, bilirubin greater than 1.5 mg/dl, serum creatinine greater than 2.0 mg/dl,
        concomitant intercurrent illnesses that would limit compliance with trial requirement or
        which are considered relevant for the evaluation of the efficacy or safety of the trial
        drug, chemo-, hormone- or immunotherapy within the past four weeks or within less than four
        half-life times of the previous drug prior to treatment with the trial drug (whatever is
        the longest period), radiotherapy within the past four weeks prior to treatment with the
        trial drug, men or women who are sexually active and unwilling to use a medically
        acceptable method of contraception during the trial, pregnancy or lactation, treatment with
        any other investigational drug within the past four weeks or within less than four
        half-life times of the investigational drug before treatment with the trial drug (whatever
        is the longest period), patient unable to comply with the protocol, patients who are
        considered eligible by the investigator for other second-line chemotherapy, radiotherapy or
        immunotherapy, patients who have received more than two lines of prior anti-tumour therapy
        for advanced or metastatic non small cell lung cancer