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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	11 November 2013
Main ID:	EUCTR2008-004148-35-IE
Date of registration:	11/08/2008
Prospective Registration:	Yes
Primary sponsor:	Merck KGaA
Public title:	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
Scientific title:	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
Date of first enrolment:	19/04/2010
Target sample size:	215
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004148-35
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
Phase:

Countries of recruitment
Belgium	Czech Republic	France	Germany	Ireland	Italy	Spain

Contacts

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Key inclusion & exclusion criteria

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 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.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Advanced non-small cell lung cancer (NSCLC)
MedDRA version: 9.1 Level: LLT Classification code 10061873 Term: Non-small cell lung cancer

Intervention(s)

Product Name: Cilengitide
Product Code: EMD 121974
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cilengitide
CAS Number: 188968-51-6
Current Sponsor code: EMD 121974
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 15-

Trade Name: Erbitux 5 mg/ml
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cetuximab
Current Sponsor code: EMD 271786
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Main Objective: Progression free survival time

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 Objective: - Efficacy in terms of:
· Overall survival time
· Best overall response
· Time to treatment failure

- Safety

Secondary Outcome(s)

Secondary ID(s)

EMR 200037-014

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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