TIGER-3
Research type
Research Study
Full title
TIGER-3: A Phase 3, Open-Label, Multicenter, Randomized Study of Oral Rociletinib (CO-1686) Monotherapy Versus Single-agent Cytotoxic Chemotherapy in Patients with Mutant EGFR Non-small Cell Lung Cancer (NSCLC) after Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase Inhibitor (TKI) and Platinum-doublet Chemotherapy
IRAS ID
171587
Contact name
Sanjay Popat
Contact email
Sponsor organisation
Clovis Oncology, Inc
Eudract number
2014-003437-26
Duration of Study in the UK
2 years, 1 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). NSCLC being 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 medicines have had notable success as these treatments are better able to distinguish between healthy and cancerous cells. Although these medicines 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 patients 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 medicine 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 rociletinib as a treatment for NSCLC participants with mutated EGFR who have previously had one targeted EGFR therapy and at least one platinum based chemotherapy treatment. It is hoped rociletinib will attack damaged EGFRs only, leading to cancer cell death, and not with healthy EGFRs, reducing some of the unwanted side-effects.REC name
London - City & East Research Ethics Committee
REC reference
15/LO/0182
Date of REC Opinion
19 Feb 2015
REC opinion
Favourable Opinion