A Single-Arm, Multicenter, Open-Label, Phase 2 Study of nab®-Paclitaxel (Abraxane®) and Carboplatin Chemotherapy plus Necitumumab (LY3012211) in the First-Line Treatment of Patients with Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

illy, S.A.0 个研究点目标入组 50 人开始时间: 2016年8月12日最近更新: 2019年12月16日

适应症

试验速览

暂无简介。

•Key Inclusion Criteria
•- Histologically or cytologically confirmed squamous NSCLC
•- Stage IV disease at the time of study entry (AJCC Staging Manual, 7th edition)
•- Measurable disease at the time of study enrollment, as defined by RECIST 1.1
•- Tumor tissue (paraffin-embedded tissue block [preferred] or 15 freshly cut unstained slides [a minimum of 6 slides] is requested) available for analysis of EGFR protein expression by immunohistochemistry (IHC).
•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 31
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 19

•Key Exclusion Criteria
•- Nonsquamous NSCLC
•- Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor
•- Previous chemotherapy for advanced NSCLC
•- Major surgery or received any investigational therapy in the 4 weeks prior to study entry
•- Systemic radiotherapy within 4 weeks prior to study entry, or focal radiotherapy within 2 weeks prior to study entry
•- Symptomatic central nervous system (CNS) malignancy or metastasis

发起方

illy, S.A.