Study of U3-1287 in Subjects with Lung Cancer

• Research type

  Research Study

• Full title

  RANDOMIZED, PLACEBO-CONTROLLED,DOUBLE-BLIND PHASE 1B/2 STUDY OF U3-1287 (AMG 888) IN COMBINATION WITH ERLOTINIB IN EGFR TREATMENT NAÏVE SUBJECTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAVE PROGRESSED ON AT LEAST ONE PRIOR CHEMOTHERAPY

• IRAS ID

  81035

• Contact name

  Andreas Polychronis

• Sponsor organisation

  Daiichi Sankyo Pharma Development

• Eudract number

  2010-021082-74

• ISRCTN Number

  mmm

• Research summary

  This is a study of an investigational drug, called U3-1287 (AMG 888), in combination with a routinely used drug, erlotinib, in treating patients with lung cancer who have already received at least one type of chemotherapy treatment. The main aim of the study is to test the effectiveness of high and low doses of this new drug when used in combination with erlotinib, against lung cancer. About 195 patients are expected to take part from approximately 67 clinics/hospitals in Europe and the United States. After undergoing certain screening procedures, suitable patients will be randomised (i.e. chosen by chance, like the flip of a coin) to receive either the study drug and erlotinib, or erlotinib and placebo (which is a dummy drug that looks like the study drug but contains no active ingredients). As the study is double-blind neither the study doctor or the patient will know which group they will be in but this could be found out in an emergency.Whilst in the study, patients will undergo several treatment cycles and have the following study procedures performed: physical examinations, vital signs recorded, Echocardiogram, tumour sample taken, CT/MRI scans, ECG, and blood and urine samples taken for laboratory tests. Participants will also be required to complete a questionnaire at regular intervals throughout the study. The number of treatment cycles a patient may receive is not fixed and so a patient??s length of participation in the study will depend on how they respond to the study treatment. At the end of the study, patients who experience clinical benefit from the study treatment may be offered the opportunity to enter a separate study in order to continue the study medication.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  11/LO/1219

• Date of REC Opinion

  10 Oct 2011

• REC opinion

  Further Information Favourable Opinion