drugset / Trial / NCT01998919

A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.

NCT01998919 ↗

Phase 2 Completed 154 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2006-08
Primary completion
2011-11
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 150 mg Oral
Background Carboplatin Small molecule 5 unknown Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Gemcitabine Small molecule 1250 mg/m2 Intravenous