CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Erlotinib (Tarceva)drug
Likely dose
Not stated in record
Key inclusion· 7
  • ECOG performance status 0-1
  • Age 18 years or older
  • Weight loss less than 10% in the preceding 3 months
  • Adjuvant chemotherapy is permitted if completed more than 6 months before protocol entry
Key exclusion· 3
  • Clinical brain metastases
  • Prior chemotherapy for systemic disease
  • Imminent need for chemotherapy for impending organ dysfunction

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

Search/NCT00585533
NCT00585533Phase 2Completed

A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer

University of Utah·interventional·Posted Jan 3, 2008·Updated Jul 30, 2013

In Brief

A Phase 2 clinical trial evaluating Erlotinib (Tarceva) for Lung Cancer. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at some point in the future and may prolong the time to chemotherapy related progression. Patients will remain on study until disease progresses, a decline in performance status, if patient cannot tolerate the side effects or develops symptoms requiring conventional chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 3, 2008
Enrollment StartJun 1, 2004
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 18.5 years ago

Interventions

Erlotinib (Tarceva)drug

Erlotinib