Survival follow up of JO25567, a randomized phase 2 study comparing erlotinib and bevacizumab combination with erlotinib alone in NSCLC patients harboring EGFR mutation.

Study identification

• EU PAS number:
  EUPAS25131
• Study ID:
  25132
• Official title and acronym:
  Survival follow up of JO25567, a randomized phase 2 study comparing erlotinib and bevacizumab combination with erlotinib alone in NSCLC patients harboring EGFR mutation.
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  A follow up study to JO25567 comparing overall survival in NSCLC patients harboring EGFR mutation between two treatment groups - bevacizumab plus erlotinib versus erlotinib alone.
• Study status:
  Finalised

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Actual:23/04/2014

Study start date

Actual:13/06/2014

Date of final study report

Actual:19/06/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Chugai Pharmaceutical Co., Ltd.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)

Other study registration identification numbers and links

JO29424