CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 76 enrolled
Drug / intervention
Pemetrexed +2 moredrug
Likely dose
Not stated in 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/NCT01139775
NCT01139775Phase 2Completed

A Phase 1/Randomized Phase 2 Study to Evaluate LY2603618 in Combination With Pemetrexed and Cisplatin in Patients With Stage IV Non-small Cell Lung Cancer

Eli Lilly and Company·interventional·Posted Jun 9, 2010·Updated May 18, 2018

In Brief

A Phase 2 clinical trial evaluating Pemetrexed, Cisplatin, and 1 other intervention for Non Small Cell Lung Cancer. Completed, enrolled 76 participants across 24 sites in 2 countries.

Detailed Summary

LY2603618 is a selective inhibitor of the deoxyribonucleic acid (DNA) damage checkpoint kinase 1 (CHK1). It was being developed as a chemotherapeutic-enhancing agent in the treatment of cancer. Phase 1 studies have shown the feasibility of combining LY2603618 with either gemcitabine or pemetrexed. The objective of this study was to find the dose of LY2603618 that can be safely combined with standard doses of pemetrexed and cisplatin and to test if this triplet offered a significant improvement in progression-free survival (PFS) in participants with Stage IV nonsquamous non-small cell lung cancer (NSCLC) in the first-line of palliative treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 9, 2010
Enrollment StartFeb 1, 2011
Primary CompletionMay 1, 2013
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.1 years ago

Interventions

Pemetrexeddrug

Administered intravenously as a continuous 10-minute infusion

Cisplatindrug

Administered intravenously as a continuous 1-hour infusion

LY2603618drug

Administered intravenously as a continuous 1-hour infusion