Trial information
A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.
Status: No longer recruiting
Protocol number: MO18633
Sponsor: Hoffmann-La Roche Inc
Company division: Pharmaceutical
Official Scientific Title: A randomised double-blind study to evaluate the effect of first-line treatment with Tarceva in combination with gemcitabine/platinum chemotherapy on non tumour progression rate in patients with advanced non-small cell lung cancer.
Brief summary: This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is 100-500 individuals. Target sample size is 120.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: erlotinib[Tarceva]
Primary outcome: 1. Non tumour progression rate (complete remission, partial remission, stable disease maintained >16 weeks)
Key secondary outcomes: 1. Efficacy: Objective response rate; duration of response; time to progression; progression-free survival; overall survival. Safety: AEs, lab tests.
Inclusion criteria:
- adult patients, >=18 years of age;
- histologically documented advanced or recurrent stage IIIB or IV non-small cell lung cancer;
- measurable disease;
- no previous chemotherapy for non-small cell lung cancer.
Exclusion criteria:
- unstable systemic disease;
- any other malignancies in the last 5 years.
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: 06/16/2006
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Campbelltown
- Liverpool
- Sydney
China
- Guangzhou
- Hong Kong
- Shanghai
Indonesia
- Jakarta
- Jogjakarta
- Semarang
Korea, Republic of
Philippines
Taiwan
Thailand
