Trial information
MERIT Study - A Study of Tarceva (Erlotinib) in Patients With Non-Small Cell Lung Cancer (NSCLC)
Status: No longer recruiting
Protocol number: BO18279
Sponsor: Hoffmann-La Roche Ltd/Roche Global Development
Company division: Pharmaceutical
Official Scientific Title: MERIT - A non-randomized, open-label efficacy marker identification trial for Tarceva in second-line non-small cell lung cancer patients
Brief summary: This study will assess potentially predictive markers of efficacy in patients with NSCLC receiving oral Tarceva therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals. Target sample size is
265.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: erlotinib[Tarceva]
Primary outcome: 1. Potentially predictive markers: gene expression profiles in tumor tissue and normal cells; gene mutation analysis for EGFR and other molecules involved in EGFR signal transduction; other marker assessments that may correspond with Tarceva efficacy.
Key secondary outcomes: 1. Efficacy: Overall response and clinical benefit rates; Safety: adverse events and serious adverse events; laboratory tests.
Inclusion criteria:
- adult patients >=18 years of age;
- advanced NSCLC;
- tumor accessible for biopsy by bronchoscopy;
- disease progression following >=1 course of standard chemotherapy, or patients unwilling/unable to undergo chemotherapy.
Exclusion criteria:
- unstable systemic disease;
- any other malignancies in the last 5 years;
- brain metastases;
- previous treatment with therapy acting on the EGFR axis.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2005
Trial registration date: 12/12/2005
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Bulgaria
China
Estonia
France
Germany
Italy
Poland
- Gdansk
- Lodz
- Lublin
- Poznan
Russian Federation
Singapore
Spain
Taiwan
United Kingdom
