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

Roche

Status and phase

Completed

Phase 3

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Treatments

Drug: Placebo

Drug: gemcitabine

Drug: Platinum chemotherapy (cisplatin or carboplatin)

Drug: erlotinib [Tarceva]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00883779

MO22201

Details and patient eligibility

About

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.

Enrollment

451 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.