MEDI4736 in NSCLC (D4191C00001, PACIFIC Study)

• Research type

  Research Study

• Full title

  A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)

• IRAS ID

  154164

• Contact name

  Corinne Faivre-Finn

• Contact email

  corinne.finn@christie.nhs.uk

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2014-000336-42

• Clinicaltrials.gov Identifier

  NCT02125461

• Duration of Study in the UK

  4 years, 6 months, 29 days

• Research summary

  Research Summary
  This is a Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy and safety of the study drug MEDI4736 compared with placebo in male and female patients with locally advanced, unresectable NSCLC (Stage III), who have not progressed following definitive, platinum-based, concurrent chemoradiation therapy.

  Approximately 880 patients will be enrolled and 702 patients randomised at 260 to 330 sites worldwide. Participants will be randomised in a 2:1 ratio (MEDI4736 to placebo) to 1 of 2 treatment arms:

  • MEDI4736 (10 mg/kg every 2 weeks [Q2W] intravenous [IV] for up to 12 months)
  • Placebo (matching placebo for infusion Q2W IV for up to 12 months).

  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).

  Following completion or discontinuation of study drug, patients will enter a follow-up period.
  Once a patient has had objective progression recorded and has discontinued study drug, the patient will be followed up for survival status every 2 months until death, withdrawal of consent or the end of the study.

  Summary of Results
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fs3.amazonaws.com%252Fctr-med-7111%252FD4191C00001%252F5253288a-15c6-48e2-a5b4-20315b70234e%252Fc6a4cb41-9d23-4208-8d38-87c9a85afe0c%252FD4191C00001-CSR_synopsis_redacted-v1.pdf%2FNBTI%2Fwj24AQ%2FAQ%2Ff5aa818b-6339-485a-8786-03a934ecd49f%2F2%2FpYdPZSt0bC&data=05%7C02%7Cgmcentral.rec%40hra.nhs.uk%7C2a47a99d044a4143ef0608dcdcda6ae1%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638628077854301355%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=QewJnt1W5eNpTbFbPnCmBozgDViaj0EIGvRtBFzDJu8%3D&reserved=0

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  15/NW/0015

• Date of REC Opinion

  3 Feb 2015

• REC opinion

  Further Information Favourable Opinion