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

Trial Profile

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

Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 24 Jul 2017

At a glance

  • Drugs Rociletinib (Primary) ; Erlotinib
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TIGER-1
  • Sponsors Clovis Oncology
  • Most Recent Events

    • 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.
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