Loading clinical trials...

Avelumab in First-line NSCLC (JAVELIN Lung 100) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT02576574•EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female subjects aged greater than or equal to (\>=) 18 years
•With Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
•At least 1 measurable tumor lesion
•With histologically confirmed metastatic or recurrent (Stage IV) non-small cell lung cancer (NSCLC)
•With availability of a recently-obtained, formalin-fixed, paraffin-embedded (FFPE) tissue sample containing tumor (biopsy from a non-irradiated area preferably within 6 months) or a minimum number of 10 (preferably 25) unstained tumor slides cut within 1 week, and suitable for PD-L1 expression assessment
•Subjects must not have received any treatment for systemic lung cancer, and have an estimated life expectancy of more than 12 weeks
•Other protocol defined criteria could apply

Exclusion Criteria

•Known severe hypersensitivity reactions to monoclonal antibodies (Grade \>= 3 NCI CTCAE v 4.03), history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma), and persisting toxicity related to prior therapy of Grade \> 1 NCI-CTCAE v 4.03.
•Subjects with brain metastases are excluded, except those meeting the following criteria: brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to randomization, subjects must be either off steroids or on a stable or decreasing dose of \<= 10 mg daily prednisone (or equivalent), and do not have ongoing neurological symptoms that are related to the brain localization of the disease.
•Other protocol defined criteria could apply

Locations (349)

Clearview Cancer Institute

Huntsville, Alabama, United States

Arizona Center for Cancer Care

Surprise, Arizona, United States

Sharp Memorial Hospital

San Diego, California, United States

University Cancer Institute

Boynton Beach, Florida, United States

South Georgia Medical Center

Valdosta, Georgia, United States

Christus Cancer Treatment Center

Shreveport, Louisiana, United States

Henry Ford Hospital

Detroit, Michigan, United States

St. Vincent Frontier Cancer Center

Billings, Montana, United States

Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

San Juan Oncology Associates

Farmington, New Mexico, United States

Key Dates

Start Date

October 29, 2015

Primary Completion Date

December 6, 2021

Completion Date

January 29, 2024

Last Updated

January 31, 2025

Enrollment

1,214

ACTUAL participants

Conditions

First Line Non-Small Cell Lung Cancer

Interventions

Avelumab

DRUG

Pemetrexed

DRUG

Paclitaxel

DRUG

Gemcitabine

DRUG

Gemcitabine

DRUG

Carboplatin

DRUG

Cisplatin

DRUG

Carboplatin

DRUG

Avelumab Weekly

DRUG