An Open-label Randomized Multinational Phase 3 Trial of Nivolumab Versus Docetaxel in Previously Treated Subjects With Advanced or Metastatic Non-small Cell Lung Cancer (CheckMate 078: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 078)
Phase of Trial: Phase III
Latest Information Update: 30 Nov 2017
At a glance
- Drugs Nivolumab (Primary) ; Docetaxel
- Indications Non-small cell lung cancer
- Focus Therapeutic Use
- Acronyms CheckMate 078
- Sponsors Bristol-Myers Squibb
- 30 Nov 2017 According to a Bristol-Myers Squibb media release, Prof. Yi-Long Wu, a tenured professor of the Guangdong Lung Cancer Institute and the Guangdong General Hospital, chair of the Chinese Thoracic Oncology Group (CTONG) is the principal investigator of CheckMate -078 trial.
- 30 Nov 2017 According to a Bristol-Myers Squibb media release, the company has submitted a Biologics License Application (BLA) for Opdivo to the China Food and Drug Administration (CFDA) for the proposed indication of previously treatedNSCLC, which has been accepted by the CFDA.
- 30 Nov 2017 Status changed from active, no longer recruiting to discontinued, because the independent Data Monitoring Committee (DMC) concluded that the study met its primary endpoint, demonstrating superior overall survival (OS) in patients receiving Opdivo compared with the control arm, as reported in a Bristol-Myers Squibb media release.