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

AstraZeneca AB0 个研究点目标入组 770 人开始时间: 2014年9月3日最近更新: 2023年12月4日

适应症

试验速览

暂无简介。

•- 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

•- 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)

发起方