A Global Study to Assess the Effects of MEDI4736 (durvalumab), 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

Study identifier:D4191C00004

ClinicalTrials.gov identifier:NCT02352948

EudraCT identifier:2014-000338-46

CTIS identifier:N/A

Study Complete

Official 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).

Medical condition

non - small cell lung cancer NSCLC

Phase

Phase 3

Healthy volunteers

No

Study drug

MEDI4736 (durvalumab), Vinorelbine, Gemcitabine, Erlotinib, MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4), tremelimumab (anti-CTLA4)

Sex

All

Actual Enrollment

597

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 13 Jan 2015
Primary Completion Date: 09 Feb 2018
Study Completion Date: 30 Aug 2023

Study design

Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria