Avelumab in First-line NSCLC (JAVELIN Lung 100)

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

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.

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany

  collaborator INDUSTRY

• EMD Serono Research & Development Institute, Inc.

  lead INDUSTRY

Principal Investigators

• Medical Responsible · EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-29

Primary Completion

2021-12-06

Completion

2024-01-29

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

Study Locations