MEDI4736 and Tremelimumab in NSCLC (D4191C00004, ARCTIC Study)

• Research type

  Research Study

• Full title

  A Phase III, Open label, Randomised, Multi-centre, International Study 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 (Stage IIIB-IV) who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum-based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC)

• IRAS ID

  154166

• Contact name

  Toby Talbot

• Contact email

  toby.talbot@rcht.cornwall.nhs.uk

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2014-000338-46

• Duration of Study in the UK

  1 years, 9 months, 21 days

• Research summary

  This global study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of the study drug MEDI4736 versus Standard of Care treatment in NSCLC patients with PD-L1-positive tumours (Sub-study A), and the combination of MEDI4736 + tremelimumab versus Standard of Care treatment in NSCLC patients with PD-L1-negative tumours (Sub-study B).

  The study will enroll male and female participants with locally advanced or metastatic NSCLC who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC.

  Assignment to the applicable sub-study will be preceded by the Pre-screening Period during which assessment of the participant’s PD-L1 status (based on a tumour sample) will take place. After confirmation of PD-L1 status, patients will enter the
  main Screening Period within their assigned sub-study.

  The treatment period for the study is up to 12 months - If participants maintain disease control throughout the treatment period they will be given the option to be treated with the same study drug for a second treatment period (again, up to 12 months) upon evidence of confirmed progressive disease (PD).
  Lay summary of study results:
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclassic.clinicaltrials.gov%252Fct2%252Fshow%252Fresults%252FNCT02352948%253Fterm%253DD4191C00004%2526draw%253D2%2526rank%253D1%2FNBTI%2F1w_2AQ%2FAQ%2Fd84baa9f-fa71-46c3-808b-cbf4727b64b8%2F2%2FkLOUmuXQ7p&data=05%7C02%7CTracy.Hamrang%40hra.nhs.uk%7C0e5ea2ee91794cf2e60208dcaa350aac%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638572391985594392%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=dxSdneMtISBIgG%2Fm2hz5gCuv6s4ZtnaSOHE%2BU2UpDJ0%3D&reserved=0

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  15/SC/0065

• Date of REC Opinion

  19 Mar 2015

• REC opinion

  Further Information Favourable Opinion