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)

A Phase 3, 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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222776

Enrollment

Registered

2015-03-02

Start date

2015-05-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Interventions

investigational material(s) Generic name etc : Sub-study A: MEDI4736, Sub-study B: MEDI4736 in combination with tremelimumab (anti-CTLA4) INN of investigational material : Therapeutic category code :

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Documented evidence of NSCLC (Stage IIIB/ IV disease) - Disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional regimen for treatment of NSCLC - World Health Organization (WHO) Performance Status of 0 or 1 - Estimated life expectancy more than 12 weeks

Exclusion criteria

Exclusion criteria: - Prior exposure to any anti-PD-1 or anti-PD-L1 antibody or anti CTLA4 - Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids ) - Active or prior documented autoimmune disease within the past 2 years - Evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis B, C and HIV - Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy - Known EGFR TK activating mutations or ALK rearrangements - Any prior Grade 3 immune-related adverse event (irAE) or more while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1 - Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS) and Progression-Free Survival (PFS)	—

Countries

Australia, Belgium, Bulgaria, Canada, Chile, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Netherlands, Poland, Republic of Korea, Romania, Russian Federation, Serbia, Singapore, Spain, Taiwan, Thailand, United Kingdom, United States

Contacts

Public ContactKazushige Hibi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026