At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Placebo-controlled, Double-blind Phase II of Sequential Administration of Tarceva (Erlotinib) or Placebo in Combination With Gemcitabine/Platinum as First-line Treatment in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC).
In Brief
A Phase 2 clinical trial evaluating erlotinib [Tarceva], placebo, and 3 other interventions for Non-Small Cell Lung Cancer. Completed, enrolled 154 participants across 19 sites in 8 countries.
Detailed 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 (150 mg 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.
Study Details
Timeline
Interventions
150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily
orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application
1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles
75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin
5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin