CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 195 enrolled
Drug / intervention
Gefitinib +1 moredrug
Likely dose
Gefitinib 250 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/NCT01469000
NCT01469000Phase 2Completed
CompareCT.gov

A Randomised Phase 2 Trial of Pemetrexed and Gefitinib Versus Gefitinib as First Line Treatment for Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations

Eli Lilly and Company·interventional·Posted Nov 10, 2011·Updated Sep 10, 2019

In Brief

A Phase 2 clinical trial evaluating Gefitinib and Pemetrexed for Carcinoma, Non Small Cell Lung. Completed, enrolled 195 participants across 25 sites in 4 countries.

Detailed Summary

The purpose of this study is to compare the combination of pemetrexed and gefitinib versus gefitinib alone, in terms of progression-free survival. This study is in participants who have stage IV non squamous NSCLC with activating epidermal growth factor mutations and who have not had any previous chemotherapy for stage IV disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non Small Cell Lung
CountriesChina, Japan, South Korea, Taiwan
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2011
Enrollment StartFeb 1, 2012
Primary CompletionApr 1, 2015
Study CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 14.6 years ago

Interventions

Gefitinibdrug

250 mg orally once per day. Number of cycles until disease progression or unacceptable toxicity develops.

Pemetrexeddrug

500 mg/m² IV on day 1 of each 21 day cycle. Number of cycles until disease progression or unacceptable toxicity develops.