CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 enrolled
Drug / intervention
Sorafenib +1 moredrug
Likely dose
Sorafenib 400 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/NCT00609804
NCT00609804Phase 2Completed
CompareCT.gov

Randomized Phase II Trial of Sorafenib and Erlotinib or Sorafenib Alone in Patients With Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib

SCRI Development Innovations, LLC·interventional·Posted Feb 7, 2008·Updated Apr 8, 2016

In Brief

A Phase 2 clinical trial evaluating Sorafenib and Erlotinib for Non-Small Cell Lung Cancer. Completed, enrolled 53 participants across 16 sites.

Detailed Summary

This is a randomized, open-label, multi-center, Phase II study of treatment of patients with advanced NSCLC who have progressed on erlotinib with the combination of sorafenib and erlotinib or sorafenib alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesUnited States
CollaboratorsBayer, OSI Pharmaceuticals

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 7, 2008
Enrollment StartMar 1, 2008
Primary CompletionMay 1, 2012
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 18.4 years ago

Interventions

Sorafenibdrug

Sorafenib 400 mg twice daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.

Erlotinibdrug

Erlotinib 150 mg once daily by mouth