Trial information
A Study of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer Naive to Chemotherapy.
Status: No longer recruiting
Protocol number: MO18660
Sponsor: Hoffmann-La Roche AG
Company division: Pharmaceutical
Official Scientific Title: An open label study to evaluate the effect of Tarceva on disease progression rate in non-smoking and current/former smokers with advanced non-small cell lung cancer, naïve to chemotherapy.
Brief summary: This study will evaluate the efficacy and safety of Tarceva in two groups of patients with non-small cell lung cancer who have not been pre-treated with chemotherapy. One group, consisting of patients who have never smoked, will receive Tarceva 150mg/day, and the other group, consisting of current/former smokers, will receive Tarceva 150mg/day increasing to a maximum of 300mg/day. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 indivduals. Target sample size is
44.
Study phase: II
Study type: Interventional; Treatment; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: erlotinib[Tarceva]
Primary outcome: 1. Non-progression rate at 8 weeks
Key secondary outcomes: 1. Efficacy: Objective response rate and disease control rate, duration of response, time to progression, progression free survival, overall survival. Safety: AEs, lab parameters.
Inclusion criteria:
- adult patients, >=18 years of age;
- histologically documented advanced non-small cell lung cancer (stage IIIB/IV);
- ECOG performance status 0-2;
- no previous chemotherapy.
Exclusion criteria:
- previous therapy which acts on EGFR axis;
- clinical evidence of brain metastasis;
- any unstable systemic disease;
- unable to take oral medication.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: August, 2006
Trial registration date: 07/19/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
France
Germany
Italy
Netherlands
Spain
United Kingdom
