0806: Open Label study of IMC-11F8 in first line treatment of NSCLC

• Research type

  Research Study

• Full title

  A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

• IRAS ID

  34212

• Contact name

  Elaine Rankin

• Eudract number

  2009-013838-25

• Research summary

  Lung cancer is the most common cancer in the world and is the second most common cancer diagnosed in the UK. Approximately 87% of all lung cancers are classified as non-small cell lung cancer (NSCLC) for the purposes of evaluation and treatment. When feasible, surgery is the treatment of choice for localized disease. However, the majority of patients with lung cancer have disease that is advanced and has spread beyond the lungs at diagnosis. Patients with advanced NSCLC who receive no treatment survive on average 4 months after diagnosis whereas patients treated with standard combination chemotherapy survive on average 10 months after diagnosis. New approaches to the treatment of advanced NSCLC, which can further improve the efficacy of first-line treatment and therefore increase survival, are needed. This study will investigate the effectiveness of an experimental drug called IMC-11F8. IMC-11F8 is a type of drug called a ??recombinant human monoclonal antibody?. The monoclonal antibody is being developed to block a signalling pathway in the body which is involved in cancer development and growth. It is hoped that by treating NSCLC patients with IMC-11F8 in addition to standard chemotherapy, overall survival will increase. This is the study??s primary objective. 947 adult participants with advanced NSCLC who have received no prior treatment will be invited to take part in the study worldwide; approximately 10 sites in the UK will participate. All participants will be treated with a maximum of 6 3-weekly cycles of standard Gemcitabine-Cisplatin chemotherapy or until there is evidence that the cancer is growing (progressive disease, PD). Half of the participants will be randomized to receive IMC-11F8 treatment in addition to Gemcitabine-Cisplatin chemotherapy, which will continue until there is evidence of PD. All participants will be scanned every six weeks to assess PD. The study is sponsored by ImClone LLC.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  09/S0501/68

• Date of REC Opinion

  3 Feb 2010

• REC opinion

  Further Information Favourable Opinion