CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Tarceva (Erlotinib)drug
Likely dose
Tarceva (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/NCT00385996
NCT00385996Phase 2Completed
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A Pilot Study of Preoperative Tarceva (Erlotinib) Monotherapy in Patients With Early Stage (I/II) Non-Small Cell Lung Cancer

Weill Medical College of Cornell University·interventional·Posted Oct 11, 2006·Updated Dec 28, 2018

In Brief

A Phase 2 clinical trial evaluating Tarceva (Erlotinib) for Carcinoma, Non-small Cell Lung. Completed, enrolled 22 participants across 1 site.

Detailed Summary

The main purpose of this study is to see if Tarceva® (erlotinib) is effective in shrinking tumors. A high resolution CT scan (CT scanner that can view 3 dimensional images of the tumor) will be used to measure the tumor before and after treatment with Tarceva®(erlotinib) . This type of CT scan will measure the tumor by volume and by standard measurement (length and width). Both methods will be compared to find out whether standard measurement or measurement by tumor volume is more accurate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-small Cell Lung
CountriesUnited States
CollaboratorsOSI Pharmaceuticals

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 11, 2006
Enrollment StartOct 1, 2006
Primary CompletionNov 1, 2008
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.7 years ago

Interventions

Tarceva (Erlotinib)drug

Patients will receive daily erlotinib at 150 mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.