Study of IMC-1121B in Patients with Non-small Cell Lung Cancer

• Research type

  Research Study

• Full title

  An Open-label, Multicenter, Randomized, Phase 2 Study of a Recombinant Human Anti-VEGFR 2 Monoclonal Antibody, IMC 1121B in Combination with Platinum-based Chemotherapy versus Platinum-based Chemotherapy Alone as First line Treatment of Patients with Recurrent or Advanced Non small Cell Lung Cancer (NSCLC)

• IRAS ID

  47917

• Contact name

  Tim Eisen

• Sponsor organisation

  ImClone LLC

• Eudract number

  2009-016784-11

• Research summary

  This is a study of a new drug, called IMC-1121B, in combination with chemotherapy as treatment of patients with lung cancer. It has been designed and is being funded by a pharmaceutical company called ImClone LLC. It is planned that approximately 280 patients will be involved in the study from a total of 50-70 centres in North America and Europe. Suitable patients will be randomised (chosen by chance) into one of four treatment groups where they will receive combination study treatment for a minimum of four 3-week cycles, up to six cycles. Participants will then enter a maintenance phase and continue to receive study treatment. Participants can continue to receive study treatment until their disease gets worse or they experience unacceptable side effects or they are withdrawn from the study for other reasons. During their participation, patients will undergo the following study procedures: medical history recorded; physical examinations (including height and weight); vital signs recorded (blood pressure, pulse rate, respiratory rate, temperature); electrocardiograms (ECGs); pregnancy tests (if applicable); neurological assessments; blood and urine samples taken for laboratory safety testing; CT (computerised tomography) or MRI (magnetic resonance imaging) scans; and tumour assessments. It is hoped the results from this study will help to develop a new treatment for patients with non-small cell lung cancer in the future.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  10/H1005/45

• Date of REC Opinion

  12 Jan 2011

• REC opinion

  Further Information Favourable Opinion