CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 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/NCT01000480
NCT01000480Phase 2Completed
CompareCT.gov

Phase 2 Study of Pemetrexed and Cisplatin as Induction, Followed by Pemetrexed and Cisplatin With Concurrent Thoracic Radiotherapy, in Patients With Unresectable, Locally Advanced, Stage III, Nonsquamous Non-Small Cell Lung Cancer

Eli Lilly and Company·interventional·Posted Oct 23, 2009·Updated Apr 2, 2014

In Brief

A Phase 2 clinical trial evaluating Pemetrexed, Cisplatin, and 1 other intervention for Non Small Cell Lung Cancer. Completed, enrolled 90 participants across 21 sites in 4 countries.

Detailed Summary

This trial investigates pemetrexed and cisplatin followed by pemetrexed and cisplatin in combination with radiotherapy in participants with locally advanced, non-small cell lung cancer (NSCLC). The purpose of the study is to assess the antitumor activity as measured by progression free survival 1 year after start of treatment with study drug.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Small Cell Lung Cancer
CountriesFrance, Germany, Italy, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 23, 2009
Enrollment StartOct 1, 2009
Primary CompletionJan 1, 2013
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.7 years ago

Interventions

Pemetrexeddrug

500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of a 21 day cycle for 2 cycles: with possibility of 2 additional cycles.

Cisplatindrug

75 mg/m² intravenous infusion on Day 1 of a 21 day cycle for 2 cycles; with the possibility of 2 additional cycles.

Thoracic Radiotherapyradiation

Administered at 2 gray (Gy)/fraction after completion of the pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and will continue daily (5 days per week) until the total delivered dose reaches a therapeutic goal of 66 Gy, over approximately 7 weeks.