ARQ197 plus Erlotinib for treating non-small-cell lung cancer

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects with Locally Advanced or Metastatic, Non-Squamous, Non–Small-Cell Lung Cancer (NSCLC)

• IRAS ID

  73482

• Sponsor organisation

  Daiichi Sankyo Development Limited

• Eudract number

  2010-022365-10

• ISRCTN Number

  not known

• Research summary

  Lung cancer is one of the leading causes of cancer-related deaths in industrialised countries, with non-small cell lung cancer (NSCLC) accounting for the majority of cases. This is a multinational, multi-centre, randomised, double-blinded, placebo controlled phase 3 clinical trial. The study drug, ARQ197, is one of a new class of drugs found to have the potential to treat cancer. These drugs may stop a process in the body that can cause the spread of cancer tumours (invasiveness) and lead to other cancer tumours being formed (metastasis). The aim of the trial is to look at the overall survival (OS) of patients with treatable non-small cell lung cancer.To date ARQ197 has been tested in over 500 people in clinical trials. In this study approximately 1000 patients with advanced non-squamous NSCLC who have had one or two prior treatments will be enrolled worldwide. The study will last about 30 months but may be longer as patients may continue to receive treatment for as long as their cancer does not get worse.It is expected that most patients will receive between 3 and 6 treatment cycles (12 to 24 weeks of treatment). Patients will be randomly assigned into two treatment groups: Group 1: ARQ 197 plus erlotinib or Group 2: Placebo plus erlotinib. Patients will have an equal chance of being in Group 1 or Group 2. In either group, patients receive erlotinib. The study involves a 21 day screening period. Following this patients return for the first treatment visit (Cycle 1, Day 1)and then once every week for 4 weeks, until Cycle 2, Day 1. After Cycle 2, Day 1, patients will return for study visits every 2 weeks. During the study several tests and examinations will be done to closely monitor patients' health and wellbeing.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  11/LO/0540

• Date of REC Opinion

  5 Jul 2011

• REC opinion

  Further Information Favourable Opinion