CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 792 enrolled
Drug / intervention
Avelumab +1 moredrug
Likely dose
Avelumab 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/NCT02395172
NCT02395172Phase 3Completed
CompareCT.gov

A Phase III Open-Label, Multicenter Trial of Avelumab (MSB0010718C) Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer That Has Progressed After a Platinum-Containing Doublet

EMD Serono Research & Development Institute, Inc.·interventional·Posted Mar 20, 2015·Updated Aug 3, 2020

In Brief

A Phase 3 clinical trial evaluating Avelumab and Docetaxel for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 792 participants across 260 sites in 29 countries.

Detailed Summary

The main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Chile, Colombia, Croatia, Czechia, Denmark, France, Hungary, Israel, Italy, Japan, Mexico, Peru, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
CollaboratorsMerck KGaA, Darmstadt, Germany

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 20, 2015
Enrollment StartMar 24, 2015
Primary CompletionNov 22, 2017
Study CompletionDec 3, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.3 years ago

Interventions

Avelumabdrug

Participants received 10 milligrams per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.

Docetaxeldrug

Participants received 75 mg per square meter (m\^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.