NGR014: Randomized Phase II Study of NGR-hTNF in Combination With Standard Chemotherapy Versus Standard Chemotherapy Alone in Previously Untreated Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Eligible patients will be randomly assigned to a standard chemotherapy regimen plus low-dose
(0.8 mcg/m^2) NGR-hTNF or standard chemotherapy alone, through a centralized randomization
process using the following stratification factors: performance status (0 vs 1) and
histology (squamous vs non-squamous). In both arms the choice between the two chemotherapy
regimens will be based on the histologic subtype: in patients with squamous histology
(including also generic diagnosis of NSCLC without further subtype classification) is
recommended cisplatin/gemcitabine regimen, in patients with nonsquamous histology (including
adenocarcinoma and large-cell carcinoma) is recommended cisplatin/pemetrexed regimen.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS) defined as time from the randomization until to objective disease progression or death due any cause.
from the randomization until to objective disease progression or death
Yes
Antonio Lambiase, MD
Study Director
MolMed S.p.A.
Italy: Ethics Committee
NGR014
NCT00994097
July 2009
December 2013
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