CP-751,871 in combination with gemcitabine and cisplatin in NSCLC

• Research type

  Research Study

• Full title

  A4021017, Randomized, Open Label, Phase 3 Clinical Study to Evaluate the Effect of the Addition of CP-751,861 to Gemcitabine and Cisplatin in Patients with Advanced Non Small Cell Lung Cancer

• IRAS ID

  28092

• Contact name

  David Ferry

• Sponsor organisation

  Pfizer Inc

• Eudract number

  2008-004008-30

• Research summary

  A PHASE 3 OPEN LABEL STUDY IN SUBJECTS WITH LUNG CANCER TO EVALUATE EFFECT OF CP-751,871 WITH GEMCITABINE AND CISPLATIN This study is intended to test the clinical benefit of the addition of CP-751,871 (study drug) (figitumumab) to standard chemotherapy regimens (gemcitabine and cisplatin) in patients with non small cell lung cancer (NSCLC). It is a randomised study and 1 in 2 patients will receive the study drug. NSCLC is a leading cause of cancer mortality with a dismal prognostic in advanced disease and new therapies that may provide outcome for these patients are urgently needed. Early clinical data suggests that when given in combination with standard chemotherapy, CP-751,871 may be able to improve the outcome for patients with advanced non-small cell lung cancer. 40 countries worldwide are participating in this study, including Australia, US, Canada, Europe and India. Approximately 1100 patients are planned on being enrolled into the study over a period of 20 months - 550 in the study arm (gemcitabine, cisplatin and study drug CP-751,871) and 550 in the control arm (standard treatment of gemcitabine and cisplatin). In the UK, the study will be conducted by specialist oncologists at NHS hospitals in England, Wales and Scotland at the hospital Oncology Units and specialised cancer care centres. Participants will be randomly allocated to 1 of 2 groups: Arm A - participants will receive Gemcitabine, Cisplatin plus the study drug CP-751,871 and on Arm B, participants will receive Gemcitabine and Cisplatin (standard therapy). Treatment will be given intravenously in 3 week cycles (1 cycle = 3 weeks) for a maximum of 6 cycles. Tumour assessments using computed tomography (CT) scans, or magnetic resonance imaging (MRI), as appropriate will be performed at baseline and every 6 weeks thereafter until disease progression or upon initiation of subsequent anticancer therapy. The study is expected to last 2 years.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  09/H1008/117

• Date of REC Opinion

  25 Feb 2010

• REC opinion

  Further Information Favourable Opinion