CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
Pemetrexed +2 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/NCT00409006
NCT00409006Phase 2Completed

A Phase 2 Trial of Pemetrexed and Cisplatin Followed Sequentially by Gefitinib Versus Pemetrexed and Cisplatin in Asian "Never Smoker" Patients With Advanced Non-Small Cell Lung Cancer

Eli Lilly and Company·interventional·Posted Dec 8, 2006·Updated Sep 9, 2010

In Brief

A Phase 2 clinical trial evaluating Pemetrexed, Cisplatin, and 1 other intervention for Non-small Cell Lung Cancer. Completed, enrolled 70 participants across 7 sites in 3 countries.

Detailed Summary

The purpose of this study is to compare the efficacy and safety of chemotherapy followed sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified as 'never smoker' since it is suggested that these patients are more likely to respond favorably to treatment with gefitinib.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina, South Korea, Taiwan
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 8, 2006
Enrollment StartFeb 1, 2007
Primary CompletionAug 1, 2009
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 19.6 years ago

Interventions

Pemetrexeddrug

500 milligrams per meter squared (mg/m2), administered by intravenous (IV) infusion every 21 days for 4 cycles (1-4) or 500 mg/m2, IV, every 21 days until disease progression or unacceptable toxicity.

Cisplatindrug

75 mg/m2, IV, every 21 days for 4 cycles (1-4) or 75 mg/m2, IV, every 21 days for 4 cycles with optional continuation for 2 additional cycles until disease progression or unacceptable toxicity

Gefitinibdrug

250 mg, administered orally once daily beginning at Cycle 5 until disease progression or unacceptable toxicity