CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 109 enrolled
Drug / intervention
Pemetrexed +2 moredrug
Likely dose
Pemetrexed 500 milligramfrom 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/NCT01004250
NCT01004250Phase 2Completed

A Single-Arm, Phase 2 Trial of Pemetrexed, Cisplatin,and Bevacizumab as Induction, Followed by Pemetrexed and Bevacizumab as Maintenance, in First-Line Treatment of Nonsquamous Advanced NSCLC

Eli Lilly and Company·interventional·Posted Oct 29, 2009·Updated May 21, 2014

In Brief

A Phase 2 clinical trial evaluating Pemetrexed, Cisplatin, and 1 other intervention for Non-Small Cell Lung Cancer. Completed, enrolled 109 participants across 19 sites in 5 countries.

Detailed Summary

Participants with advanced non-small cell lung cancer (NSCLC) will receive a first-line treatment of Pemetrexed, Cisplatin and Bevacizumab as induction therapy followed by a maintenance treatment of Pemetrexed and Bevacizumab. Treatment will continue until disease progression or unacceptable toxicity occurs. The primary objective of this study is to measure how long this treatment could prevent the disease progression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark, Germany, Italy, Spain, Sweden
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 29, 2009
Enrollment StartOct 1, 2009
Primary CompletionNov 1, 2012
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 16.7 years ago

Interventions

Pemetrexeddrug

500 milligram per square meter (mg/m²) given intravenously on Day 1 of each 21-day cycle for four cycles of Induction Therapy, and continued in Maintenance Therapy until progression or unacceptable toxicity.

Cisplatindrug

75 mg/m² given intravenously on Day 1 of 21-day cycle for a maximum of 4 cycles

Bevacizumabdrug

7.5 milligram per kilogram (mg/kg) given intravenously on Day 1 of 21-day cycle for four cycles of Induction Therapy, and continued in Maintenance Therapy until progression or unacceptable toxicity