A Single-Arm, Multicenter, Phase 2 Study of Gemcitabine-Carboplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Patients with Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Eli Lilly and Company0 个研究点目标入组 50 人开始时间: 2016年9月15日最近更新: 2017年8月28日

适应症

试验速览

暂无简介。

•- Have confirmed diagnosis of locally advanced or metastatic NSCLC predominantly squamous histology. Squamous NSCLC diagnosis must be
•confirmed by histology or cytology local pathology report.
•- Has an EGFR protein expressing tumor (defined by local IHC test).
•- Measurable disease at the time of study entry as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
•- Has tumor tissue available for biomarker analyses.
•- Has resolution of all clinically significant toxic effects of prior adjuvant and/or neoadjuvant chemotherapy, surgery, radiotherapy (with the exception of alopecia) to Grade =1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0.
•- Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1
•- Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy (Biologic agents (for example, antibodies) and Immunotherapy >=4 weeks; Chest radiotherapy >= weeks; Major surgery, excluding biopsy >=4 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 44
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 6

•- Has nonsquamous NSCLC
•- Has received prior anticancer therapy targeting the EGFR, vascular
•endothelial growth factor (VEGF), or VEGF receptor
•- Has received previous chemotherapy (including concurrent
•chemoradiation) for advanced NSCLC (patients who have received adjuvant
•and/or neoadjuvant chemotherapy are eligible if the last administration
•occurred at least 1 year prior to start of therapy).
•- Has undergone major surgery or received any investigational
•therapy in the 4 weeks prior to study enrollment.
•- Has undergone chest irradiation within 4 weeks prior to study
•enrollment (except palliative irradiation of bone lesions, which is allowed).
•- Has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants.
•- Has a bleeding tumor
•- History of arterial or venous thromboembolism within 3 months prior to study enrollment.
•- Has a history or evidence of current clinically-relevant coronary artery disease of current = Class III as defined by Canadian Cardiovascular Society Angina Grading Scale (Campeau 1976) or congestive heart failure of current = Class III as defined by the New York Heart Association.
•- Has experienced myocardial infarction within 6 months prior to study enrollment.

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