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TIGER-3: A Phase 3, Open-label, Multicenter, Randomized Study of Oral Rociletinib (CO-1686) Monotherapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC) After Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase Inhibitor (TKI) and Platinum-doublet Chemotherapy

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Trial Profile

TIGER-3: A Phase 3, Open-label, Multicenter, Randomized Study of Oral Rociletinib (CO-1686) Monotherapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC) After Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase Inhibitor (TKI) and Platinum-doublet Chemotherapy

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Rociletinib (Primary) ; Docetaxel; Gemcitabine; Paclitaxel; Pemetrexed
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TIGER-3
  • Sponsors Clovis Oncology [CEASED]

    • Most Recent Events

    • 18 Oct 2017 Initial results of this study presented at the 18th World Conference on Lung Cancer.
    • 07 Jun 2016 Trial design presented at the 52nd Annual Meeting of the American Society of Clinical Oncology.
    • 05 May 2016 According to Clovis Oncology media release, the FDA issued a CRL stating that the application is not ready for approval. Hence, company has terminated enrollment in all ongoing studies. Clovis has withdrawn its MAA for rociletinib previously filed with European regulatory authorities.

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