CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 247 enrolled
Drug / intervention
pemetrexed +1 moredrug
Likely dose
pemetrexed 500 milligramsfrom 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/NCT00550173
NCT00550173Phase 2Completed

A Randomized Phase 2 Study Comparing Erlotinib-Pemetrexed, Pemetrexed Alone, and Erlotinib Alone, as Second-Line Treatment for Non-Smoker Patients With Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer

Eli Lilly and Company·interventional·Posted Oct 29, 2007·Updated Feb 13, 2013

In Brief

A Phase 2 clinical trial evaluating pemetrexed and erlotinib for Non-Small-Cell Lung Cancer. Completed, enrolled 247 participants across 29 sites in 7 countries.

Detailed Summary

The purpose of this study is to compare the combination of erlotinib and pemetrexed versus either pemetrexed alone and erlotinib alone, in terms of progression-free survival (time until the objective worsening of the disease) in patients who have never smoked and have locally advanced or metastatic Nonsquamous Non-Small Cell Lung Cancer who have failed a first-line chemotherapy treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, China, Hong Kong, India, South Korea, Taiwan, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 29, 2007
Enrollment StartNov 1, 2007
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 18.7 years ago

Interventions

pemetrexeddrug

500 milligrams per meter squared (mg/m\^2), intravenous (IV), every (q) 21 days until progression or unacceptable toxicity develops

erlotinibdrug

150 mg, orally, once daily until progression or unacceptable toxicity develops