A Global Study to Assess the Effects of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 E

Clinical Trial Details

ARCTIC

A Global Study to Assess the Effects of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (ARCTIC)

Purpose/Objective

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Full Trial Details: ClinicalTrials.gov

Condition: Lung Cancer
Study Type: Interventional
Phase: Phase III
Study Start Date: 01/28/2015
Study Completion Date: TBD

This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib [TARCEVA®]), gemcitabine or vinorelbine (NAVELBINE®).

NCT Number
NCT02352948
Principal Investigator(s)
Paul Thambi, MD
Sponsor(s)
AstraZeneca
Participant Eligibility
  • Age: 18 - No Maximum
  • Gender: Female

Location

  • Shady Grove Adventist Aquilino Cancer Center
    9905 Medical Center Drive
    Rockville, MD 20850
    Main: 240-826-6297

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