CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 315 enrolled
Drug / intervention
Erlotinib [Tarceva]drug
Likely dose
Not stated in 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/NCT01183858
NCT01183858Phase 3Completed

A Prospective, Double-blind Randomized Phase III Study of 300 mg Versus 150 mg Erlotinib in Current Smokers With Locally Advanced or Metastatic NSCLC in Second-line Setting After Failure on Chemotherapy (CURRENTS)

Hoffmann-La Roche·interventional·Posted Aug 18, 2010·Updated Aug 19, 2015

In Brief

A Phase 3 clinical trial evaluating Erlotinib [Tarceva] for Non-Small Cell Lung Cancer. Completed, enrolled 315 participants across 63 sites in 9 countries.

Detailed Summary

This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib \[Tarceva\] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina, Denmark, Egypt, France, Germany, Netherlands, Spain, Switzerland, Turkey (Türkiye)
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 18, 2010
Enrollment StartOct 1, 2010
Primary CompletionOct 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.9 years ago

Interventions

Erlotinib [Tarceva]drug

Single daily oral dose