TIGER 1: A Randomized, Open-Label, Phase 2/3 Study of CO-1686 or Erlotinib as First-Line Treatment of Patients With EGFR-Mutant Advanced/Metastatic NSCLC
Phase of Trial: Phase II/III
Latest Information Update: 11 Sep 2017
At a glance
- Drugs Rociletinib (Primary) ; Erlotinib
- Indications Non-small cell lung cancer
- Focus Registrational; Therapeutic Use
- Acronyms TIGER-1
- Sponsors Clovis Oncology
- 10 Jun 2017 Biomarkers information updated
- 05 May 2016 According to Clovis Oncology media release, company was notified that it could anticipate receiving a Complete Response Letter (CRL) for the rociletinib NDA on or before the PDUFA date of June 28, 2016 but the FDA issued a CRL stating that the application is not ready for approval. Hence, company has terminated enrollment in all ongoing studies.
- 05 May 2016 Status changed from active, no longer recruiting to discontinued, as reported by Clovis Oncology media release.