EUCTR2014-000338-46-ESActive, not recruitingNot Applicable
A Phase III, Open label, Randomised, Multi-centre, International Study of MEDI4736, 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) - ARCTIC
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca AB
- Enrollment
- 770
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Aged at least 18 years
- •- 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 616
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 154
Exclusion Criteria
- •- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
- •- 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) 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)
Investigators
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