CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 361 enrolled
Drug / intervention
Pemetrexed +3 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/NCT00948675
NCT00948675Phase 3Completed

A Study of Pemetrexed Plus Carboplatin Followed by Maintenance Pemetrexed vs Paclitaxel Plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients With Advanced NCSLC of Nonsquamous Histology

Eli Lilly and Company·interventional·Posted Jul 29, 2009·Updated Oct 29, 2021

In Brief

A Phase 3 clinical trial evaluating Pemetrexed, Carboplatin, and 2 other interventions for Advanced Non-Small Cell Lung Cancer. Completed, enrolled 361 participants across 45 sites.

Detailed Summary

The purpose of this study is to compare the regimens of pemetrexed, carboplatin with pemetrexed maintenance and paclitaxel, carboplatin, bevacizumab with bevacizumab maintenance in participants with Stage IV nonsquamous non-small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 29, 2009
Enrollment StartSep 1, 2009
Primary CompletionJan 31, 2013
Study CompletionNov 6, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 16.9 years ago

Interventions

Pemetrexeddrug

Induction therapy: 500 milligrams/square meter (mg/m²) given intravenously every 21 days for 4 cycles. Maintenance therapy: 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.

Carboplatindrug

Induction Therapy (every 21 days for 4 cycles): Area Under the Curve (AUC) 6 \[maximum possible dose of 900 milligrams (mg)\] intravenously infused over 30 minutes.

Paclitaxeldrug

Induction Therapy (every 21 days for 4 cycles): 200 mg/m² intravenously infused over 3 hours

Bevacizumabbiological

Induction therapy: 15 milligrams/kilogram (mg/kg) given intravenously every 21 days for 4 cycles. Maintenance therapy: 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.