Trial information
A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.
Status: Recruiting
Protocol number: ML20063
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study comparing the effect of first-line therapy with Tarceva + gemcitabine versus gemcitabine monotherapy on treatment response in treatment-naïve patients with advanced non-small cell lung cancer
Brief summary: This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 120.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: erlotinib [Tarceva]
Primary outcome: 1. Progression free survival Time frame: Event driven
Key secondary outcomes: 1. Overall response rate, disease control rate, duration of response, overall survival. Time frame: Event driven
2. AEs, SAEs, vital signs. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable disease ;
- ECOG PS 2;
- adequate organ function.
Exclusion criteria:
- prior chemotherapy or systemic anti-tumor therapy;
- hypersensitivity to erlotinib;
- any condition contraindicating the use of the study medication and/or impairing the interpretation of results and/or leading to treatment-related complications.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: August, 2007
Trial registration date: 08/15/2007
Date last updated: 10/15/2008
Link to trial result
This trial is being conducted at the following locations:
Australia
- Greenslopes
- Lismore
- Melbourne
- Parkville
- Perth
- Richmond
- St. Leonards
- Wodonga
- Wollongong
