Trial information
A Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer.
Status: No longer recruiting
Protocol number: ML20322
Sponsor: Roche Taiwan
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study to compare the effect of Tarceva and Vinorelbine on response rate in chemonaive, elderly patients with advanced non-small cell lung cancer
Brief summary: This study will compare the efficacy and safety of Tarceva and vinorelbine in chemonaive elderly patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150mg po daily) or vinorelbine (60mg/m2 on days 1 and 8 of each 3 week cycle). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 114.
Study phase: IV
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. Complete and partial response; time to disease progression
Key secondary outcomes: 1. Efficacy:overall survival; progression-free survival. Safety: AEs; lab parameters.
Inclusion criteria:
- adult patients, >=70 years of age;
- non-small cell lung cancer;
- naive to prior chemotherapy or specific immunotherapy;
- >=1 measurable lesion.
Exclusion criteria:
- active non-controlled infection or disease;
- CNS metastases;
- any other malignancies (other than adequately treated basal cell cancer of skin, or in situ cancer of the cervix).
Gender: Males or Females
Age limits: Min: 70 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2007
Trial registration date: 10/30/2006
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Taiwan
