CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 113 enrolled
Drug / intervention
Pemetrexed +2 moredrug
Likely dose
Pemetrexed 500 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/NCT00867009
NCT00867009Phase 2Completed

A Phase 2 Study of Pemetrexed and Cisplatin Plus Cetuximab Followed by Pemetrexed and Cetuximab Maintenance Therapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB or IV) Other Than Predominantly Squamous Cell Histology

Eli Lilly and Company·interventional·Posted Mar 23, 2009·Updated Jun 15, 2015

In Brief

A Phase 2 clinical trial evaluating Pemetrexed, Cisplatin, and 1 other intervention for Non-Small-Cell Lung Cancer. Completed, enrolled 113 participants across 24 sites in 6 countries.

Detailed Summary

This study will estimate the response rate in patients with advanced or metastatic non-squamous Non-Small Cell Lung Cancer. Patients who don't progress after 4 to 6 cycles of induction treatment with pemetrexed, cisplatin and cetuximab will receive maintenance treatment with pemetrexed and cetuximab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Germany, Greece, Italy, Netherlands, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 23, 2009
Enrollment StartApr 1, 2009
Primary CompletionMay 1, 2011
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 17.3 years ago

Interventions

Pemetrexeddrug

Induction therapy: 500 mg/m², intravenous, on Day 1 of each 21-day cycle for 4 to 6 cycles Maintenance therapy: 500 mg/m², intravenous, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation

Cisplatindrug

Induction therapy: 75 mg/m², intravenous, on Day 1 of each 21-day cycle for 4 to 6 cycles

Cetuximabdrug

Induction therapy: Loading dose of 400 mg/m², intravenous, on Day 1 of cycle 1, then 250 mg/m², intravenous, weekly for 4 to 6 cycles, 21 day cycles Maintenance therapy: 250 mg/m², intravenous, weekly until progressive disease or treatment discontinuation