CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 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/NCT00518011
NCT00518011Phase 2Completed
CompareCT.gov

A Randomized, Open Label Study Comparing the Effect of First-line Therapy With Tarceva + Gemcitabine Versus Gemcitabine Monotherapy on Treatment Response in Treatment-naïve Patients With Advanced Non-small Cell Lung Cancer

Hoffmann-La Roche·interventional·Posted Aug 17, 2007·Updated May 16, 2016

In Brief

A Phase 2 clinical trial evaluating Erlotinib and Gemcitabine for Non-Squamous Non-Small Cell Lung Cancer. Completed, enrolled 17 participants across 14 sites.

Detailed Summary

This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Squamous Non-Small Cell Lung Cancer
CountriesAustralia
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 17, 2007
Enrollment StartAug 1, 2007
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.9 years ago

Interventions

Erlotinibdrug

150 mg po daily

Gemcitabinedrug

As prescribed