Cilengitide and cetuximab in combination with platinum-based chemotherapy as first-linetreatment for subjects with advanced NSCLCOpen-label, randomized, controlled, multicenter Phase II study investigating 2 cilengitide regimensin combination with cetuximab and platinum-based chemotherapy (cisplatin/vinorelbine orcisplatin/gemcitabine) compared to cetuximab and platinum-based chemotherapy alone as first-linetreatment for patients with advanced NSCLC (CERTO) - ND
- Conditions
- MedDRA version: 12.0Level: LLTClassification code 10029519Term: Non-small cell lung cancer stage IIIADVANCED NON-SMALL CELL LUNG CANCER (NSCLC)
- Registration Number
- EUCTR2008-004148-35-IT
- Lead Sponsor
- MERCK KGAA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 215
1. Written informed consent obtained before undergoing any study-related activities.
2. Male or female, at least 18 years of age.
3. Histologically confirmed NSCLC, stage IIIb with documented malignant pleural effusion or stage IV.
4. Archived tumor material sample for retrospective central histology, KRAS mutational analysis, EGFR status, and further biomarker research.
5. 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.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
3. Brain metastasis and/or leptomeningeal disease
(known or suspected).
4. Radiotherapy (except localized radiotherapy for pain relief), major surgery or 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 is allowed).
6. History of coagulation disorder associated with bleeding or recurrent thrombotic events.
7. Recent peptic ulcer disease (endoscopically proven gastric, duodenal or esophageal ulcer) within
6 months of study treatment start.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: PROGRESSION FREE SURVIVAL TIME;Secondary Objective: EFFICACY IN TERMS OF:<br>- OVERALL SURVIVAL TIME<br>- BEST OVERALL RESPONSE<br>- TIME TO TREATMENT FAILURE<br>- SAFETY;Primary end point(s): SAFETY RUN-IN: TO DETERMINE THE MTD OF CILENGITIDE IN COMBINATION WITH CETUXIMAB AND PLATINUM-BASED CHEMOTHERAPY (CISPLATIN/VINORELBINE OR CISPLATIN/GEMCITABINE). RANDOMIZED PART: TO ASSESS THE EFFICACY OF 2 CILENGITIDE REGIMENS IN COMBINATION WITH CETUXIMAB AND PLATINUM-BASED CHEMOTHERAPY (CISPLATIN/VINORELBINE OR CISPLATIN/GEMCITABINE)COMPARED TO CETUXIMAB AND PLATINUM-BASED CHEMOTHERAPY ALONE IN TERMS OF PROGRESSION-FREE SURVIVAL (PFS) TIME
- Secondary Outcome Measures
Name Time Method