Open Label Phase II Study of BI 2536 BS Monotherapy in Patients With Recurrent Small Cell Lung Cancer

Inclusion Criteria:

Inclusion Criteria:

- Patients with histologically or cytologically confirmed, -sensitive-relapse- SCLC
defined by a relapse 60 days or more after cessation of prior first-line
chemotherapy.

- Patients with at least one measurable lesion, with longest diameter to be recorded as
20 mm or greater.

- Life expectancy of at least three months and ECOG performance score of 2 or less and
written informed consent that must be consistent with ICH-GCP Guidelines.

Exclusion Criteria:

Exclusion Criteria:

- More than one prior regimen of chemotherapy, mixed small cell/large cell or combined
small cell histology.

- Symptomatic brain metastases or leptomenigeal disease

- Patients with ascites, patients who have any other life-threatening illness or organ
system dysfunction, or other malignancies diagnosed within the past five (5) years
(other than non melanomatous skin cancer)

- Absolute neutrophil count (ANC) <1,500/µl, platelet count <100,000/µl, or hemoglobin
<9 mg/dl

- Total bilirubin >1.5 x ULN, aspartame amino transferase (AST) and/or alanine amino
transferase (ALT) >2.5 x ULN, or aspartate amino transferase (AST) and/or alanine
amino transferase (ALT) >5 x ULN in case of known liver metastases, serum creatinine
>2.0 mg/dl (>176 µmol/L, SI Unit equivalent)

- Chemo-, hormone- (other than Megace®) or immunotherapy within the past 4 weeks or
within less than 4 half-life times of the previous drug prior to treatment with the
trial drug

- Radiation therapy within the past 2 weeks prior to or during treatment with the trial
drug

- Patients with any serious active infection (i.e., requiring an IV antibiotic,
antifungal, or antiviral agents), patients with known HIV, hepatitis-B or -C
infection

- Known or suspected active drug or alcohol abuse

- Treatment with any other investigational drug within the past 4 weeks or within less
than 4 half-life times of the investigational drug

- Patients with a known pre-existing coagulopathy or requiring therapeutic
anticoagulation with warfarin (Coumadin ®)

- Patients with neuropathy (sensory or motor) CTCAE 3