TIGER-2
Research type
Research Study
Full title
TIGER-2: A Phase 2, Open-Label, Multicenter, Safety and Efficacy Study of Oral CO-1686 as 2nd Line EGFR-Directed TKI in Patients with Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)
IRAS ID
150945
Contact name
Sanjay Popat
Contact email
Sponsor organisation
Clovis Oncology, Inc.
Eudract number
2013-005532-23
Duration of Study in the UK
1 years, 7 months, 0 days
Research summary
Lung cancer is a major cause of cancer-related deaths worldwide. There are several types of lung cancer and they can be divided into two main groups, small cell lung cancer and non-small cell lung cancer (NSCLC); this later group is the most common.
Medicines that kill cancer cells are common treatments for patients with NSCLC, however survival rates remain low and side-effects are significant. Some newer drugs have had notable success as these treatments are better able to distinguish between healthy and cancerous cells. Although these drugs have improved toxicity profiles, there is still room for improvement and better treatments are sought.
Epidermal growth factor receptor (EGFR) is a protein found on the surface of many tumour cells that may control tumour growth and tumour cell survival. In many cancers, the EGFRs present are often damaged. Some medicines for NSCLCs have tried to attack this damaged EGFR to selectively kill the cancer cells without attacking healthy EGFR, which is also found on the surface of healthy cells. Some subjects initially respond well to treatments targeting the damaged EGFR, but the response is not normally maintained. One reason for this is that the damaged EGFR undergoes further damage which prevents the drug from binding to the damaged EGFR stopping it killing the cancer cells. This further damage in many cases is a specific change to EGFR and is called the T790M mutation. For these patients, there are currently no approved treatments.
This study will examine the safety and efficacy of CO-1686 as a treatment for NSCLC subjects with T790M-mutated EGFR who have previously had one targeted EGFR-therapy. It is hoped CO-1686 will attack damaged EGFRs only, leading to cancer-cell death, and not with healthy EGFRs, reducing some of the unwanted side-effects.REC name
South Central - Oxford C Research Ethics Committee
REC reference
14/SC/0189
Date of REC Opinion
28 May 2014
REC opinion
Further Information Favourable Opinion