drugset / Trial / NCT00994097

NGR-hTNF in Combination With Standard Chemotherapy to Treat Patients With Advanced Non-small Cell Lung Cancer

NCT00994097

Phase 2 Completed 121 enrolled AGC Biologics S.p.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

The main objective of this study is to demonstrate superiority in progression-free survival (PFS) when NGR-hTNF is added to standard chemotherapy regimen (cisplatin/gemcitabine or cisplatin/pemetrexed) in locally advanced (stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (stage IV) or recurrent non-small cell lung cancer (NSCLC).

Timeline

Start
2009-07
Primary completion
2017-03
Completion
2017-03

Drugs

EvaluationDrugModalityDoseRoute
Subject NGR-hTNF Protein / enzyme biologic 0.8 ug/m2 Intravenous
Background Cisplatin Other / unclassified 80 mg/m2 Intravenous
Background Gemcitabine Small molecule 1250 mg/m2 Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous