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

Phase 1

• Conditions: Advanced non-small cell lung cancer (NSCLC); MedDRA version: 9.1Level: LLTClassification code 10061873Term: Non-small cell lung cancer

• Registration Number: EUCTR2008-004148-35-FR
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-12
• Study Completion: 2013-07-29
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

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.
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

Exclusion Criteria

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 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 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><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 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.