drugset / Trial / NCT00153803
Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)
Phase 3
Completed
245 enrolled
Dartmouth-Hitchcock Medical Center
Genentech, Inc. · collabSanofi · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).
Timeline
- Start
- 2005-05
- Primary completion
- 2014-04
- Completion
- 2014-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | 150 mg | Oral |