A phase II marker identification trial for Tarceva in second line NSCLC patients - MERIT

• Register: EUCTR
• Last refreshed on: 1 May 2012
• Main ID: EUCTR2004-005096-42-DE
• Date of registration: 23/01/2006
• Prospective Registration: No
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: A phase II marker identification trial for Tarceva in second line NSCLC patients - MERIT
• Scientific title: A phase II marker identification trial for Tarceva in second line NSCLC patients - MERIT
• Date of first enrolment: 20/07/2005
• 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: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Estonia, Germany, Ireland, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
-Histologically / cytologically documented advanced (Stage IIIB and IV) NSCLC where tumour tissue is accessible to biopsy via bronchoscopy.
-Measurable disease according to RECIST criteria.
-Failure of at least one prior regimen of standard chemotherapy or patients who are deemed unsuitable for chemotherapy in the investigators opinion or who are unwilling to undergo chemotherapy.
-ECOG performance status of 0 - 2.
-Life expectancy of at least 12 weeks.
-At least 4 weeks since any previous surgery or radiotherapy.
-Granulocyte count > 1,500/mm3 and platelet count > 100,000/mm3; Haemoglobin > or = 9.0 g/dL.
- SGOT (AST) and SGPT (ALT) < 2,5 x ULN in the absence of liver metastases or up to 5 x ULN in case of liver metastases.
-Alkaline phosphatase (ALP) < 2,5 x ULN. If alkaline phosphatase is > or = 2.5 x ULN, SGOT (AST) and SGPT (ALT) must be < 1.5 x ULN.
-If alkaline phosphatase is > or = 2.5 x ULN in the presence of liver metastases, SGOT and SGPT must be < 5 x ULN.
-Serum creatinine < 1.5 ULN or creatinine clearance > 60 ml/min.
-Normal serum calcium.
-Patient must be willing and able to undergo a bronchoscopy with biopsies according to the institute’s own guidelines and requirements for such procedures.
-Coagulation parameters (PTT, INR) must be within normal range.
-Platelet aggregation inhibitors must discontinued within an appropriate time period before bronchoscopy.
-Male and female patients with reproductive potential must use reliable means of contraceptive

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:
-Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding likely to affect the evaluation of the study or place the patient at risk whilst on Tarceva treatment or puts the patient at incalculable risk during biopsy.
-Any other malignancies within the last 5 years before study start (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
-Clinical evidence of brain metastasis, or have brain metastasis or spinal cord compression that is newly diagnosed and/or has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression without evidence of stable disease for at least 2 months will also cause patients to be excluded.
-Previous treatment with any therapy which acts on the EGFR axis.
-Any known significant ophthalmologic abnormalities of the surface of the eye.
-Patients using coumadin or warfarin.



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

Health Condition(s) or Problem(s) studied

Advanced (stage IIIb and IV) non small cell lung cancer

Intervention(s)

Product Name: Tarceva
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: erlotinib
CAS Number: 183319-69-9
Current Sponsor code: Ro 50-8231/OSI-774
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Product Name: Tarceva
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: erlotinib
CAS Number: 183319-69-9
Current Sponsor code: Ro 50-8231/OSI-774
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Name: Tarceva
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: erlotinib
CAS Number: 183319-69-9
Current Sponsor code: Ro 50-8231/OSI-774
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Main Objective: The primary objective is the identification of differentially expressed genes that are predictive for benefit of Tarceva treatment.

Primary end point(s): Gene expression profiles in tumour tissue and normal cells.
Gene mutation analysis for EGFR and other molecules involved in EGFR signal transduction

Secondary Objective: The secondary objectives are to assess alterations in the EGFR signalling pathways with respect to benefit from treatment.

Secondary ID(s)

BO18279

2004-005096-42-IE