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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:	1 May 2012
Main ID:	EUCTR2004-005096-42-IT
Date of registration:	21/03/2006
Prospective Registration:	No
Primary sponsor:	ROCHE
Public title:	MERIT - A phase II marker identification trial for Tarceva in second line NSCLC patients.
Scientific title:	MERIT - A phase II marker identification trial for Tarceva in second line NSCLC patients.
Date of first enrolment:	21/09/2005
Target sample size:	250
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-005096-42
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: studio in aperto If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:

Countries of recruitment
Estonia	Germany	Ireland	Italy	Spain	United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
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Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
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:

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

Health Condition(s) or Problem(s) studied

Non Small Cell Lung Cancer
MedDRA version: 6.1 Level: PT Classification code 10061873

Intervention(s)

Product Name: Erlotinib
Product Code: OSI-774
Pharmaceutical Form: Coated tablet
CAS Number: 183319-69-9
Current Sponsor code: RO 50-8231
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Product Name: Erlotinib
Product Code: OSI-774
Pharmaceutical Form: Coated tablet
CAS Number: 183319-69-9
Current Sponsor code: RO 50-8231
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Name: Erlotinib
Product Code: OSI-774
Pharmaceutical Form: Coated tablet
CAS Number: 183319-69-9
Current Sponsor code: RO 50-8231
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Primary end point(s):

Main Objective:

Secondary Objective:

Secondary Outcome(s)

Secondary ID(s)

2004-005096-42-IE

BO 18279

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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