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) - AstraZeneca D4191C00004 ARCTIC

AstraZeneca AB0 个研究点目标入组 1,300 人开始时间: 2014年7月30日最近更新: 2018年6月5日

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: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1040
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 260

•- 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 acute or chronic hepatitis B, C and HIV
•- Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy
•- Known EGFR TK activating mutations or ALK rearrangements. Patients with EGFR TK inactivating mutations eg, exon 20, are eligible.
•- 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