IMC-1121B:A Study for the Treatment of Non-Small Cell Lung Cancer

• Research type

  Research Study

• Full title

  A Phase II, Open-label Study of IMC-1121B in Combination with Paclitaxel and Carboplatin as First-line Therapy in Patients with Stage IIIB/IV Non-Small Cell Lung Cancer.

• IRAS ID

  4576

• Contact name

  James Spicer

• Sponsor organisation

  ImClone Systems Incorporated

• Eudract number

  2007-006715-22

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  Non-small cell lung cancer (NSCLC) accounts for 75-80% of all lung cancers; and the advanced stages are associated with poor survival rates with untreated patients having a median survival rate of approximately 3.9 months.IMC-1121B is an angiogenesis inhibitor; and is believed to block the promotion of the growth factor to forming new blood vessels, thus reducing the amount of blood supplied to the cancer cells.In this study, 40 adult patients with NSCLC will be evaluated for progression-free survival at 6 months of IMC-1121B administration. This is an open-label, multicentre, Phase II trial in which treatment-naive; Stage IIIB/IV NSCLC patients receive IMC-1121B administered once every 3 weeks in combination with paclitaxel and carboplatin. Approximately, 40 adult patients with NSCLC will be evaluated for progression-free survival at 6 months of IMC-1121B administration.Patients receive 10mg/kg of IMC-1121B on Day 1, administered intravenously over 60minutes. Allow time for premedication (e.g. steroids, antiemetics and antihistamines) prior to paclitaxel administration. 200mg/m2 of paclitaxel is then administered intravenously over 3hours followed by carboplatin over 30minutes on Day 1 of each 3-week cycle for a maximum of six cycles.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  08/H0804/119

• Date of REC Opinion

  18 Dec 2008

• REC opinion

  Further Information Favourable Opinion