Inclusion Criteria:

- Age>18 years old

- Cytologically or histologically documented NSCLC

- PS 0-2 (WHO scale)

- Measurable disease according to Response Evaluation Criteria in Solid Tumors (at
least one measurable lesion)

- Documented disease progression to previous treatment with docetaxel regimen in 1st
or 2nd line setting assessed by Response Evaluation Criteria in Solid Tumors with at
least one visceral or soft-tissue metastatic lesion.

- Brain metastases are allowed, given that are clinically stable and the patient does
not present neurologic symptoms.

- Previous radiotherapy, either in the adjuvant setting or for the treatment of bone
metastases, is allowed provided that the measurable lesions are outside the radiation
fields. Patients who were irradiated to ≥ 40% of bone marrow are not eligible for the
study.

- Patients must have a recent (within 7 days prior to treatment start) biochemical and
hematogical assessment as defined by adequate bone marrow (absolute neutrophil count
≥1.5 x 109 cells/L, platelets ≥100 x 109cells/L and hemoglobin ≥9 g/dL), liver (AST &
ALT ≤ 2.5x ULN, total bilirubin within normal range) and renal (serum creatinine <
1.5 x ULN). If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated
according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should
be excluded) function tests

- Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule.

- Before patient enrollment, written informed consent must be given according to
ICH/GCP and national/local regulations.

Exclusion Criteria:

- Persistence of clinically relevant treatment-related toxicities from previous
chemotherapy or radiotherapy.

- Treatment with other investigational drugs or treatment in another clinical trial
within the past four weeks before start of treatment or concomitantly with this
trial.

- Other malignancy within the past five years other than basal cell skin cancer or
carcinoma in situ of the cervix.

- Patient with reproductive potential not implementing accepted and effective method of
contraception

- History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing
drugs or to docetaxel

- Uncontrolled severe illness or medical condition (including uncontrolled diabetes
mellitus, hypertension, heart failure ≤ NYHA II, history of myocardial infarction
within the past 6 months, angina, chronic obstructive pulmonary disease (COPD),
serious infections requiring systemic antibiotic therapy (e.g. antimicrobial,
antifungal, antiviral)

- Concurrent or planned treatment with strong inhibitors or strong inducers of
cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are
already on these treatments) (see Appendix A and B)

- Prior surgery, radiation, chemotherapy, within 4 weeks prior to treatment

- Active grade ≥2 peripheral neuropathy

- Active grade ≥2 stomatitis