Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Metastatic Small Cell Lung Carcinoma

Inclusion Criteria

• •Patients ≥ 18 years affected by SCLC previously treated with at least one therapeutic regimen (including doxorubicin). However, in case of patient already pretreated with doxorubicin, a previous cumulative dose of doxorubicin \< 300 mg/m\^2 is recommended and the current treatment has to be stopped when a maximum cumulative dose of doxorubicin 550 mg/m\^2 is reached.
• •Cytology or histology confirmed SCLC at first diagnosis (patient with recurrent disease do not require a confirmatory biopsy to be eligible)
• •Measurable disease, defined as ≥ 1 unidimensional measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by CT scan according to RECIST criteria
• •ECOG Performance status 0 - 2
• •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
• •Normal cardiac function (LVEF ≥ 55%) and absence of uncontrolled hypertension
• •Patients may have had prior therapy providing the following conditions are met:
• •\- Chemotherapy, radiation therapy, hormonal therapy or immunotherapy: wash-out period of 28 days before start treatment
• •\- Surgery: wash-out period of 14 days before start treatment
• •Patients must give written informed consent to participate in the study