Cilengitide and cetuximab in combination with platinum-based chemotherapy as first-line treatment for subjects with advanced NSCLC.Open-label, randomized, controlled, multicenter Phase II study investigating 2 cilengitide regimens in combination with cetuximab and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine) compared to cetuximab and platinum-based chemotherapy alone as first-line treatment for patients with advanced NSCLC (CERTO). - CERTO

Merck KGaA0 个研究点目标入组 215 人开始时间: 2008年8月29日最近更新: 2017年8月21日

试验速览

暂无简介。

•1. Written informed consent obtained before undergoing any study-related activities.
•2. Male or female, at least18 years of age.
•3. Histologically confirmed NSCLC, stage IIIb with documented malignant pleural effusion or stage IV (according to staging system 6th edition).
•4. EGFR expression = 200 on tumor tissue determined by local testing using the kit and testing procedures described in the study MOP.
•5. Archived tumor material sample for retrospective central histology, KRAS mutational analysis, EGFR status, and further biomarker research including mutational analysis of genes such as EGFR, k-ras, b-raf (material details described in the study MOP).
•6. At least 1 radiographically documented measurable lesion in a previously non-irradiated area according to RECIST, i.e. this lesion must be adequately measurable in at least one dimension (longest diameter [LD] to be recorded) as =2 cm by conventional techniques or =1 cm by spiral CT scan.
•7. ECOG performance status 0-1.6. ECOG performance status 0-1.
•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 16
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•1. Prior treatment with an antibody or molecule targeting endothelial growth factor receptor (EGFR)- and/or vascular endothelial growth factor receptor (VEGFR)-related signaling pathways.
•2. Previous chemotherapy for NSCLC including prior adjuvant therapy.
•3. Brain metastasis and/or leptomeningeal disease (known or suspected).
•4. Radiotherapy (except localized radiotherapy for pain relief), major surgery or intake of any investigational drug in the 30 days before the start of study treatment entry.
•5. Concurrent chronic immunosuppressive or hormone anti-cancer therapy (physiologic hormone replacement or corticosteroid therapy for COPD is allowed).
•6. History of coagulation disorder associated with bleeding, recurrent or recent thrombotic events or history of hemoptysis related to bronchopulmonary cancer. Hemoptysis is defined as coughing more than a teaspoon of red blood per day.
•7. Recent peptic ulcer disease (endoscopically proven gastric, duodenal or esophageal ulcer) within 6 months of study treatment start.

发起方