Cilengitide and Cetuximab in Combination With Platinum-basedChemotherapy as First-line Treatment for Subjects With Advanced NonSmall Cell Lung Cancer (NSCLC) (CERTO)
- Conditions
- Advanced non-small cell lung cancer (NSCLC)MedDRA version: 14.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-004148-35-CZ
- 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 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 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
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.
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><br>- Safety<br>;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).<br><br>Randomized part: To assess the efficacy of cilengitide 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.;Timepoint(s) of evaluation of this end point: Duration of the trial (24 months)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Overall survival time - Best overall response - Time to treatment failure;Timepoint(s) of evaluation of this end point: Duration of the trial (24 months)