Inclusion Criteria

Inclusion criteria:

1. Histologically or cytologically documented inoperable, locally advanced (stage IIIb
with supraclavicular lymph node metastases or malignant pleural or pericardial
effusion), metastatic (stage IV) or recurrent NSCLC. Mixed tumors should be
categorized according to the predominant cell type.

2. Age ≥18 years

3. Life expectancy more than 3 months

4. ECOG performance status 0-1

5. At least one unidimensional measurable lesion (as per RECIST criteria)

6. Adequate baseline bone marrow, hepatic and renal function, defined as follows:

- Neutrophils >1.5 x 10^9/L and platelets > 100 x 10^9/L

- Bilirubin <1.5 x ULN

- AST and/or ALT <2.5 x ULN in absence of liver metastasis

- AST and/or ALT <5 x ULN in presence of liver metastasis

- Serum creatinine <1.5 x ULN

- Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50
ml/min

7. Patients may have had prior therapy providing the following conditions are met:

- Radiation therapy: wash-out period of 28 days

- Surgery: wash-out period of 14 days

8. Patients must give written informed consent to participate in the study

Exclusion criteria:

1. Prior chemotherapy or treatment with another systemic anti-cancer agent (for example
monoclonal antibody, tyrosine kinase inhibitor).

2. Patients must not receive any other investigational agents while on study

3. Patients with myocardial infarction within the last six (6) months, unstable angina,
New York Heart Association (NYHA) grade II or greater congestive heart failure, or
serious cardiac arrhythmia requiring medication

4. Uncontrolled hypertension

5. Prolonged QTc interval (congenital or acquired)

6. Patient with significant peripheral vascular disease

7. History or evidence upon physical examination of CNS disease unless adequately
treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with
standard medical therapy, or history of stroke).

8. Patients with active or uncontrolled systemic disease/infections or with serious
illness or medical conditions, which is incompatible with the protocol

9. Known hypersensitivity/allergic reaction or contraindications to human albumin
preparations or to any of the excipients

10. Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol

11. Pregnancy or lactation. Patients - both males and females - with reproductive
potential (i.e. menopausal for less than 1-year and not surgically sterilized) must
practice effective contraceptive measures throughout the study. Women of
child-bearing potential must provide a negative pregnancy test (serum or urine)
within 14 days prior to registration.