Phase 2 Study of OSI-906 and Erlotinib in Patients with Advanced NSCLC

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-controlled Phase 2 Study of Maintenance OSI-906 plus Erlotinib (Tarceva®), or Erlotinib plus Placebo in Patients with Nonprogression Following Four Cycles of 1st-line Platinum-based Chemotherapy for Advanced NSCLC

• IRAS ID

  60896

• Sponsor organisation

  OSI Pharmaceuticals, Inc.

• Eudract number

  2010-020916-12

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  A PHASE 2 STUDY TO DETERMINE PROGRESSION FREE SURVIVAL (PFS) OF MAINTENANCE OSI-906 PLUS ERLOTINIB COMPARED TO ERLOTINIB PLUS PLACEBO, IN PATIENTS WITH NONPROGRESSION FOLLOWING 4 CYCLES OF FIRST-LINE PLATINUM-BASED CHEMOTHERAPY FOR ADVANCED NON SMALL CELL LUNG CANCER (NSCLC) This study will investigate the benefit of adding OSI-906 to erlotinib in a maintenance NSCLC setting. The use of erlotinib as a switch maintenance therapy following 4 cycles of platinum-based chemotherapy has been shown to extend progression-free survival in NSCLC patients by inhibiting epidermal growth factor receptor (EGFR) tyrosine kinase (a protein implicated in disease progression). Despite extending the duration of benefit to NSCLC patients experiencing disease control, there remains a need to improve outcomes for maintenance treatment, and to overcome tumour resistance to erlotinib. OSI-906 blocks both the activity of insulin-like growth factor-1 receptor (IGF-1R) and insulin-like receptor (IR). It has been suggested that IGF-1R signaling is associated with acquired resistance of cancer cells to EGFR inhibitors such as erlotinib. By inhibiting EGFR and IGF-1R pathways simultaneously, it is believed that greater anticancer activity and an extension of PFS may be achieved. This is a multicenter, randomised, double-blind, placebo-controlled phase 2 study with an enrollment period of about 24 months. Approximately 200 NSCLC patients previously treated with 1st-line platinum-based chemotherapy will be stratified at 75 research sites globally. Participants will be assigned randomly to one of 2 treatment arms (erlotinib plus OSI-906 or erlotinib plus placebo) with a 50:50 chance of being assigned to either arm. Neither participants nor study staff will know which treatment arm participants are assigned to. Participant's tumours will be analysed prior to randomisation to determine EGFR status. General health, research related blood tests, urine tests, ECGs and CT/MRI scans will be performed throughout the study to assess participant's health and the efficacy and safety of each treatment arm.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  10/H0406/90

• Date of REC Opinion

  18 Feb 2011

• REC opinion

  Further Information Favourable Opinion