CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 166 enrolled
Drug / intervention
Erlotinib + Sorafenib +1 moredrug
Likely dose
Erlotinib + 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/NCT00600015
NCT00600015Phase 2Completed
CompareCT.gov

A Randomized Double-Blind Placebo-Controlled Phase II Trial of Sorafenib and Erlotinib or Erlotinib Alone in Previously Treated Advanced Non-Small Cell Lung Cancer

SCRI Development Innovations, LLC·interventional·Posted Jan 24, 2008·Updated Mar 10, 2022

In Brief

A Phase 2 clinical trial evaluating Erlotinib + Sorafenib and Erlotinib + Placebo for Non-Small Cell Lung Cancer. Completed, enrolled 166 participants across 16 sites.

Detailed Summary

This trial will investigate the use of the newer targeted agents erlotinib and sorafenib in patients with stage IIIB or stage IV NSCLC who have received 1-2 prior chemotherapy regimens. Patients will be randomized to receive erlotinib (150 mg/day) and sorafenib (400 mg twice daily), or erlotinib (150 mg/day) and a placebo.

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 24, 2008
Enrollment StartFeb 1, 2008
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.4 years ago

Interventions

Erlotinib + Sorafenibdrug

Patients who are randomized to Cohort A will take sorafenib 400 mg (2 x 200-mg tablets) orally twice a day, and erlotinib 150 mg orally once a day.

Erlotinib + Placebodrug

Patients who are randomized to Cohort B will take erlotinib 150 mg orally once a day and placebo orally twice a day.