NCT02576574

Avelumab in First-line NSCLC (JAVELIN Lung 100)

A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+NSCLC

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,214 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors.

Conditions

• First Line Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Avelumab	Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.
DRUG	Pemetrexed	Participants received Pemetrexed 500 milligrams per square meter (mg/m\^2) by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.
DRUG	Paclitaxel	Participants received Paclitaxel 200 mg/m\^2 by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.
DRUG	Gemcitabine	Participants received Gemcitabine 1250 mg/m\^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles when combined with cisplatin of IV injection until disease progression or unacceptable toxicities.
DRUG	Gemcitabine	Participants received Gemcitabine 1000 mg/m\^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with carboplatin until disease progression or unacceptable toxicities.
DRUG	Carboplatin	Participants received Carboplatin area under concentration curve (AUC) 5 mg/mL\*min in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with gemcitabine until disease progression or unacceptable toxicities.
DRUG	Cisplatin	Participants received Cisplatin 75 mg/m\^2 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.
DRUG	Carboplatin	Carboplatin AUC 6 mg/mL\*min by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with pemetrexed, or paclitaxel until disease progression or unacceptable toxicities.
DRUG	Avelumab Weekly	Participants received Avelumab at a dose of 10 mg/kg as a 1-hour (-10/+20 minutes) IV infusion every week for 12 consecutive weeks.

Timeline

• Start date: 2015-10-29
• Primary completion: 2021-12-06
• Completion: 2024-01-29
• First posted: 2015-10-15
• Last updated: 2025-01-31
• Results posted: 2023-01-04

Locations

349 sites across 42 countries: United States, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, New Zealand, Peru, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom