CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,252 enrolled
Drug / intervention
Erlotinib +1 moredrug
Likely dose
Erlotinib 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00373425
NCT00373425Phase 3Completed

A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma Who Have EGFR-positive Tumors

OSI Pharmaceuticals·interventional·Posted Sep 8, 2006·Updated Sep 17, 2015

In Brief

A Phase 3 clinical trial evaluating Erlotinib and Placebo for Non-small Cell Lung Cancer. Completed, enrolled 1,252 participants across 295 sites in 19 countries.

Detailed Summary

This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Poland, Romania, Russia, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2006
Enrollment StartSep 1, 2006
Primary CompletionApr 1, 2013
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 19.8 years ago

Interventions

Erlotinibdrug

150 mg tablet

Placebodrug

Placebo tablet