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Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)

NCT02395172 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 792

Last updated 2020-08-03

Study results available
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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.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Avelumab

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.

DRUG

Docetaxel

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.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · EMD Serono Inc., a business 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
2015-03-24
Primary Completion
2017-11-22
Completion
2019-12-03

Countries

  • United States
  • Argentina
  • 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

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02395172 on ClinicalTrials.gov