CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,253 enrolled
Drug / intervention
Ramucirumab +2 morebiological
Likely dose
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/NCT01168973
NCT01168973Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy

Eli Lilly and Company·interventional·Posted Jul 23, 2010·Updated Sep 25, 2019

In Brief

A Phase 3 clinical trial evaluating Ramucirumab, Placebo (for Ramucirumab), and 1 other intervention for Non-Small Cell Lung Cancer. Completed, enrolled 1,253 participants across 231 sites in 27 countries.

Detailed Summary

The purpose of the study is to compare the survival of participants who receive chemotherapy and ramucirumab versus chemotherapy alone as second line treatment for NSCLC after prior first line platinum-based chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesArgentina, Austria, Brazil, Canada, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Romania, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 23, 2010
Enrollment StartDec 1, 2010
Primary CompletionDec 1, 2013
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.9 years ago

Interventions

Ramucirumabbiological

10 milligrams per kilogram (mg/kg) administered intravenously (IV) on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Placebo (for Ramucirumab)drug

Administered IV on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Docetaxeldrug

75 milligrams per square meter (mg/m\^2) (60 mg/m\^2 for the countries of Korea and Taiwan only with protocol amendment dated 22 May 2012) administered IV on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met