ASA404 in combination with Docetaxel as 2nd line treatment of NSCLC
Research type
Research Study
Full title
A phase III, randomized, double-blind, placebo-controlled multi-center study of ASA404 in combination with docetaxel in second-line treatment of patients with locally advanced or metastatic (Stage IIIb/IV) non-small cell lung cancer (NSCLC)
IRAS ID
12382
Contact name
Rohit Lal
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2008-002309-38
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to determine if adding ASA404 to docetaxel chemotherapy makes the cancer treatment more effective in patients with locally advanced non-small cell lung cancer. Patient will be eligible to participate in this study if they have advanced NSCLC and have progressed during or following a chemotherapy regimen. The novel mechanism of action of ASA 404 may represent a new approach to treating the most prevalent cause of cancer death. ASA404 is a tumor-Vascular Disrupting Agent (Tumor-VDA) that selectively causes the collapse of existing tumor blood supply leading to extensive tumor cell death. The action of ASA 404 is distinct from that of angiogenesis inhibitors, which inhibit the formation of new tumor blood vessels. Because it is an investigational compound, the safety and efficacy profile of ASA404 has not yet been established. Access to this investigational compound is available only through carefully controlled and monitored clinical trials. This is second large trial designed to better understand the potential benefits and risks of the drug. Because of uncertainty of clinical trials, there is no guarantee that ASA 404 will ever be commercially available anywhere in the world. Approximately 900 patient worldwide will participate in this study. This study is sponsored by Novartis.
REC name
London - City & East Research Ethics Committee
REC reference
09/H0703/8
Date of REC Opinion
21 Apr 2009
REC opinion
Further Information Favourable Opinion