A7471009 EFFICACY & SAFETY STUDY OF PF-00299804 VS ERLOTINIB IN NSCLC

• Research type

  Research Study

• Full title

  A RANDOMIZED DOUBLE BLIND PHASE 3 EFFICACY AND SAFETY STUDY OF PF-00299804 VERSUS ERLOTINIB FOR THE TREATMENT OF ADVANCED NON-SMALL CELL LUNG CANCER FOLLOWING PROGRESSION AFTER, OR INTOLERANCE TO, AT LEAST ONE PRIOR CHEMOTHERAPY

• IRAS ID

  86040

• Contact name

  David Chao

• Eudract number

  2010-022656-22

• Clinicaltrials.gov Identifier

  NCT01360554

• Research summary

  This study will compare treatment with PF-00299804 versus erlotinib in locally advanced or metastatic non-small cell lung cancer (NSCLC) after at least one prior chemotherapy regimen and no more than two. Patients included on study will be assigned at random to receive blinded active PF-00299804 and blinded erlotinib placebo (Arm A of the study) or blinded active erlotinib and blinded PF-00299804 placebo (Arm B of the study) which patients will take by mouth on a continuous daily basis. Patients will be divided into groups for analysis based on cancer cell type, race, health performance status and smoking status.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  11/LO/1869

• Date of REC Opinion

  9 Jan 2012

• REC opinion

  Further Information Favourable Opinion