Trial information
A Study of Tarceva (Erlotinib) in Patients With Non-Small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Chemotherapy
Status: Completed
Protocol number: MO17426
Sponsor: F Hoffmann-La Roche Ltd/Inc/AG
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of Tarceva on treatment response in patients with locally advanced and/or metastatic non-small-cell lung cancer who have not received previous chemotherapy
Brief summary: This study will investigate different measures of the efficacy and safety of Tarceva in chemotherapy-naive patients with NSCLC. The anticipated time on study treatment is until disease progression and the target sample size is <100 individuals.
Target sample size is 46.
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. Efficacy: Non-progression rate at 6 weeks
Key secondary outcomes: 1. Efficacy: Response rate, disease control rate, duration of response, time to progression or death, overall survival
Safety: Adverse events, laboratory results
Inclusion criteria:
- adult patients >=18 years of age;
- histologically documented, inoperable, incurable, locally advanced, metastatic, or recurrent NSCLC;
- no previous chemotherapy, systemic anti-cancer therapy, or exposure to prior HER1/EGFR inhibitors;
- at least 4 weeks since prior surgery or radiotherapy.
Exclusion criteria:
- any unstable systemic disease;
- inability to take oral medication;
- any other malignancies within 5 years.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 06/24/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
France
Netherlands
United Kingdom
