CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 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/NCT00701558
NCT00701558Phase 2Completed
CompareCT.gov

An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Disease Progression in Patients With Unresectable Advanced and/or Metastatic Non-small Cell Lung Cancer

Hoffmann-La Roche·interventional·Posted Jun 19, 2008·Updated Jun 24, 2016

In Brief

A Phase 2 clinical trial evaluating Erlotinib and Gemcitabine for Non-small Cell Lung Cancer Metastatic. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m\^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer Metastatic
CountriesRomania
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 19, 2008
Enrollment StartAug 1, 2008
Primary CompletionOct 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.0 years ago

Interventions

Erlotinibdrug

150 mg po daily

Gemcitabinedrug

1000 mg/m\^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles