NCT02352948

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

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).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 597 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) 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®)

Detailed description

The study has an umbrella design with 2 sub-studies: sub-study A (randomizing patients with PD-L1 positive tumours 1:1 into MEDI4736 (durvalumab) vs. Standard of Care) and sub-study B (randomizing patients with PD-L1 negative tumours 2:3:1:2 into MEDI4736 (durvalumab) vs. MEDI4736 (durvalumab) plus tremelimumab vs. tremelimumab vs. Standard of Care. The two substudies may have different durations of recruitment periods due to differences in patient population (PD-L1 expression). They may not run concurrently with start and completion of recruitment potentially occurring at different time points.

Conditions

• Non - Small Cell Lung Cancer NSCLC

Interventions

Type	Name	Description
DRUG	MEDI4736 (durvalumab)	MEDI4736 (durvalumab) treatment by intravenous infusion
DRUG	Vinorelbine	Vinorelbine by intravenous infusion. Administered at a dose of 30 mg/m2 iv on Days 1, 8, 15 and 22 of a 28-day cycle.
DRUG	Gemcitabine	Gemcitabine by intravenous infusion. Administered at a dose of 1000 mg/m2 iv over 30 minutes on Days 1, 8, and 15 of a 28-day cycle.
DRUG	Erlotinib	Erlotinib administered at a dose of 150 mg once daily as a tablet for oral administration
DRUG	MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4)	MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) treatment by intravenous infusion
DRUG	tremelimumab (anti-CTLA4)	tremelimumab (anti-CTLA4) treatment by intravenous infusion

Timeline

• Start date: 2015-01-13
• Primary completion: 2018-02-09
• Completion: 2023-08-30
• First posted: 2015-02-02
• Last updated: 2024-07-26
• Results posted: 2019-04-16

Locations

201 sites across 26 countries: United States, Australia, Belgium, Bulgaria, Canada, Chile, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Netherlands, Poland, Romania, Russia, Serbia, Singapore, South Korea, Spain, Taiwan, Thailand, United Kingdom