Overview

A Study of Tarceva (Erlotinib) or Placebo in Combination With Platinum-Based Therapy as First Line Treatment in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
Summary
This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva or placebo, plus platinum-based therapy, as first line treatment in patients with advanced or recurrent non-small cell lung cancer. Patients will be randomized to receive gemcitabine (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by Tarceva 150mg/day or placebo from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by Tarceva or placebo monotherapy.The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Carboplatin
Cisplatin
Erlotinib Hydrochloride
Gemcitabine
Criteria
Inclusion Criteria:

- adult patients, >=18 years of age;

- advanced (stage IIIB/IV)non-small cell lung cancer;

- measurable disease;

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

Exclusion Criteria:

- prior exposure to agents directed at the HER axis;

- prior chemotherapy or systemic anti-tumor therapy after advanced disease;

- unstable systemic disease;

- any other malignancy within last 5 years, except cured basal cell cancer of skin or
cured cancer in situ of cervix;

- brain metastasis or spinal cord compression.