A Single-Arm, Multicenter, Open-Label, Phase 2 Study ofGemcitabine-Cisplatin Chemotherapy Plus Necitumumab(IMC-11F8) in the First-Line Treatment of Patients WithStage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

Eli Lilly and Company0 个研究点目标入组 70 人开始时间: 2013年2月20日最近更新: 2016年1月25日

试验速览

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•Histologically or cytologically confirmed squamous NSCLC
•Stage IV disease at time of study entry based on AJCC 7th edition
•Measurable disease at time of study entry as defined by RECIST 1.1
•The patient has an Eastern Cooperative Oncology Group performance status score of 0-1, the patient has an
•estimated life expectancy of at least 12 weeks and in the judgment of the investigator, will be able to
•complete at least 2 cycles of treatment.
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•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 NSCLC
•Major surgery or received any investigational therapy in the 4 weeks prior to study enrollment
•Chest irradiation within 12 weeks prior to study enrollment (except palliative irradiation of bone lesions,
•which is allowed)
•The patient has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants.
•(Patients who have completed radiotherapy for brain metastases at least 4 weeks prior to receiving treatment, who are now nonsymptomatic
•and have not required treatment with steroids or anticonvulsants during the 2 weeks prior to receiving treatment, are eligible.)

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