CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 280 enrolled
Drug / intervention
IMC-1121B (ramucirumab) +5 morebiological
Likely dose
IMC-1121B (ramucirumab) 10 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/NCT01160744
NCT01160744Phase 2Completed
CompareCT.gov

An Open-label, Multicenter, Randomized, Phase 2 Study of a Recombinant Human Anti-VEGFR-2 Monoclonal Antibody, IMC-1121B in Combination With Platinum-based Chemotherapy Versus Platinum-based Chemotherapy Alone as First-line Treatment of Patients With Recurrent or Advanced Non-small Cell Lung Cancer (NSCLC)

Eli Lilly and Company·interventional·Posted Jul 12, 2010·Updated Sep 13, 2019

In Brief

A Phase 2 clinical trial evaluating IMC-1121B (ramucirumab), Pemetrexed, and 4 other interventions for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 280 participants across 53 sites in 6 countries.

Detailed Summary

The purpose of this study is to determine if participants with Stage IV NSCLC have a better outcome when treated with IMC-1121B in combination with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin than when treated with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesBelgium, Canada, Germany, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 12, 2010
Enrollment StartSep 1, 2010
Primary CompletionJan 1, 2014
Study CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.0 years ago

Interventions

IMC-1121B (ramucirumab)biological

10 milligrams/kilogram (mg/kg) once every 3 weeks beginning Day 1, Cycle 1

Pemetrexeddrug

500 milligrams/square meter (mg/m²) on Day 1 of every 21-day cycle

Carboplatin (AUC 6)drug

Day 1 of every 21-day cycle

Cisplatindrug

75 mg/m² intravenous (IV) on Day 1 of each 21-day cycle

Gemcitabinedrug

1000 mg/m² on Days 1 and 8 of every 21-day cycle

Carboplatin (AUC 5)drug

Day 1 of every 21-day cycle