Conditions: Small Cell Lung Cancer
Keywords: NGR-hTNF SCLC
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 28
Healthy volunteers: no

Brief summary:
The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic small cell lung carcinoma (SCLC) patients previously treated with at least one therapeutic regimen

Detailed description:
This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic SCLC, previously treated with at least one therapeutic regimen, that will be conducted using Simon's two-stage design method.

Arms:
arm 1: NGR-hTNF plus doxorubicin

Interventions: intervention 1: NGR-hTNF intervention 2: Doxorubicin
Intervention descriptions: intervention 1: iv q3W 0.8 mcg/sqm NGR-hTNF intervention 2: iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion

Protocol document: