MK3475-010-00

• Research type

  Research Study

• Full title

  A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) versus Docetaxel in Previously Treated Subjects with Squamous Histology Non-Small Cell Lung Cancer

• IRAS ID

  121801

• Contact name

  Dean Fennell

• Sponsor organisation

  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., (Merck)

• Eudract number

  2012-004391-19

• ISRCTN Number

  n/a

• Research summary

  This study will involve subjects with Non small cell lung cancer (NSCLC).Lung cancer has a high incidence in UK.It is the second most common cancer with 41,428 new cases in 2009 but is the most common cause of cancer death.In 2010, there were 34,859 deaths from lung cancer in the UK. patients are often treated with platinum-containing doublet chemotherapy.Therapy for patients with this stage of disease is not curative, and disease progression is expected. While docetaxel is an accepted second-line standard of care for patients with NSCLC, the objective response rate is about 10%, median progression-free survival is about 3 months, and the median overall survival is about 7.5 months.Improvemends in overall survival are needed since no one with progressive NSCLC is cured.Many of the recent new treatment advances for NSCLC are applicable to those patients with a nonsquamous histology (i.e. bevacizumab, pemetrexed, erlotinib, and crizotinib).Advances in the treatment of squamous cell histology have lagged behind those of adenocarcinoma. Immuno-modulatory agents have shown promising efficacy in multiple cancer types.The drug being tested in this study is an immuno-modulatory agent (PD-1 inhibitor).This is a randomised trial looking at the safety and efficacy of two doses of MK-3475 compared to docetaxel in previously treated subjects with squamous Non small cell lung cancer.Docetaxel is currently the standard second line treatment for this patient population.There are three areas to the study, 2 different doses of MK-3475 and docetaxel.Subjects have equal chance of being allocated one of the three treatment options.The first 18 patients will be enrolled on the lower MK-3475 dose to provide early efficacy data.If this dose is discontinued then patients will have an equal chance of being assigned to the remaining MK-3475 dose or docetaxel.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  13/SC/0102

• Date of REC Opinion

  25 Mar 2013

• REC opinion

  Further Information Favourable Opinion