ADX13036 Non–interventional, Retrospective Tissue Sample Collection
Research type
Research Study
Full title
Non–interventional, Retrospective Tissue Sample Collection Follow-up to Amgen Study 20050244 (Study of Denosumab Compared with Zoledronic Acid in the Treatment of Bone Metastases in Subjects with Advanced Cancer or Multiple Myeloma)
IRAS ID
166727
Contact name
Peter Kerr
Contact email
Sponsor organisation
Almac Diagnostics
Duration of Study in the UK
0 years, 5 months, 28 days
Research summary
The study objective is to collect archived tissue samples from the patients recruited to the Amgen study 20050244 for the purposes of identifying a biomarker of response to denosumab. The Amgen clinical trial (ClinicalTrials.gov ID NCT00330759, Amgen ID 20050244) showed that patients with NSCLC (Non-Small Cell Lung Carcinoma) who received denosumab had improved overall survival based on a retrospective analysis (Scagliotti 2012). This finding was observed consistently in patients with adenocarcinoma, squamous cell carcinoma, and in patients with and without visceral metastases. Denosumab represents a potential novel treatment option in patients with lung cancer.
This biomarker if validated could support the future use of denosumab in the clinical management of advanced lung cancer. Identification of those patients that benefit most from this treatment would enhance the effectiveness of a denosumab treatment regimen as well as prevent potential side-effects in patients who would likely be unresponsive to denosumab.
The primary objective is to assess whether the relative benefit on overall survival in NSCLC patients from treatment with denosumab versus zoledronic acid in Amgen Study 20050244 is associated with tumour RANK and/or RANKL expression.
The study is sponsored by Amgen working in partnership with Almac research organisation (CRO)
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0066
Date of REC Opinion
17 Mar 2015
REC opinion
Favourable Opinion