JVBA - Docetaxel and Ramucirumab for treating lung cancer

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression after One Prior Platinum-Based Therapy

• IRAS ID

  59951

• Contact name

  Conrad Lewanski

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2010-021297-11

• ISRCTN Number

  n/a

• Research summary

  Lung cancer is the most common cancer in the world and is the main cause of cancer deaths. Around 1.2 million people die from lung cancer each year. 85% of lung cancers are non-small cell lung cancers (NSCLC).Surgical removal of the tumour is possible for early stage disease where the cancer has not spread. However most cases of NSCLC are diagnosed at an advanced stage or when the cancer has already spread. Standard treatment is chemotherapy with platinum based medicines (cisplatin or carboplatin). The life expectancy of NSCLC patients is still low with signs of disease returning after 4 to 6 months of treatment.One promising treatment for cancer is stopping new blood vessels being made in tumours (angiogenesis). If new blood vessels are not made the tumour cannot grow and the cancer cannot spread. Scientists have discovered that angiogenesis is controlled by chemicals made in the body called vascular endothelial growth factors (VEGF). The study drug, ramucirumab, is an antibody that attaches to tumours and blocks the action of a VEGF. This means that the tumour stops growing. Clinical trials with ramucirumab have already shown that the drug is an effective treatment for a variety of cancers. The aim of this study is to compare the survival rates of two groups of NSCLC patients. One group of patients is treated with the study drug, ramucirumab, combined with another chemotherapy drug docetaxel; the other group is treated with docetaxel and a placebo. A placebo is a dummy medicine that looks like the real medicine but has no active ingredients.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  11/LO/0190

• Date of REC Opinion

  28 Apr 2011

• REC opinion

  Further Information Favourable Opinion