140470
Research type
Research Study
Full title
A Phase II, randomised, open-label study of Gemcitabine/Carboplatin first-line chemotherapy in combination with or without the antisense oligonucleotide Apatorsen (OGX-427) in advanced squamous cell lung cancers
IRAS ID
140470
Contact name
Peter Schmid
Contact email
Sponsor organisation
Queen Mary, University of London
Eudract number
2014-000199-25
Research summary
This study is being carried out to see if a new drug called Apatorsen in combination with standard Gemcitabine/Carboplatin chemotherapy is effective in treating advanced squamous cell lung cancer.
Non-small cell lung cancer (NSCLC) is the leading cause of cancerrelated death in the UK. Despite substantial progress in the treatment of non-squamous subtypes of NSCLC, there has been little change in the management of the squamous cell subtype. Squamous cell lung cancer comprises approximately 30-45% of all NSCLCs. It remains the subtype with poorest outcome and there is a significant need to develop new therapies for this group of patients especially.
Gemcitabine and carboplatin are chemotherapy drugs that are routinely given to patients with squamous cell lung cancer. Apatorsen is a new anti-cancer treatment that OncoGenex is developing; it is not yet approved for use. The main purpose of this study is to see if Apatorsen, when combined with Gemcitabine/Carboplatin, is an effective treatment for squamous cell lung cancer. Also included is a biomarker component to find out if patients whose tumours have certain molecular changes may derive more benefit from this treatment.
Apatorsen is an experimental drug that removes a protein called Hsp27 from cancer cells. Hsp27 can help cancer cells protect themselves against the effects of cancer treatments and can therefore cause resistance to chemotherapy. In animal studies and laboratory experiments, Apatorsen has been shown to make cancers more sensitive to gemcitabine and carboplatin and so make this chemotherapy treatment more effective.
This study will recruit 140 patients, aged 18 and over, with squamous cell lung cancer that has spread to other parts of the body. Consenting patients will be randomly placed into one of two treatment groups. One group will receive Gemcitabine/Carboplatin chemotherapy in combination with . The other group will receive Gemcitabine/Carboplatin chemotherapy alone.
Gemcitabine/Carboplatin chemotherapy will be continued for up to 6 cycles. Treatment with Apatorsen will be continued until the disease worsens, treatment-limiting toxicity, or death due to any cause.REC name
London - City & East Research Ethics Committee
REC reference
14/LO/0418
Date of REC Opinion
11 Apr 2014
REC opinion
Further Information Favourable Opinion