M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Non-small Cell Lung Cancer

In brief

The main purpose of this study was to evaluate safety and efficacy in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab.

Key facts

Study ID

NCT03840902

Run by

EMD Serono Research & Development Institute, Inc.

People needed

153

Starts

2019-04-16

Expected to finish

2023-02-17

Last updated by the study team

2024-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have histologically documented NSCLC who present with Stage III locally advanced, unresectable disease (International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology
• Participants with tumor harboring an Epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, Anaplastic lymphoma kinase (ALK) translocation, ROS-1 rearrangement are eligible.
• Participants must have adequate pulmonary function defined as a forced expiratory volume in 1 second (FEV1) greater than equals to (>=) 1.2 liters or >= 50% of predicted normal volume measured within 3 weeks prior to randomization.
• Adequate hematological, hepatic and renal function as defined in the protocol
• Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies

You may not qualify if…

• Participants with Mixed small cell with non-small cell lung cancer histology
• Recent major surgery within 4 weeks prior to entry into the study
• Significant acute or chronic infections including human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome, Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection and active tuberculosis
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization
• Active autoimmune disease that has required systemic treatment in past 1 year (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
• Any prior systemic cytotoxic chemotherapy for their NSCLC or any antibody or drug targeting T-cell coregulatory proteins

Where it is running

• UCLA Hematology Oncology - Main Site - 2020 Santa Monica — Santa Monica, California, United States
• University of Colorado Health - Memorial Hospital - Memorial Hospital — Colorado Springs, Colorado, United States
• Hematology Oncology Associates — Fort Collins, Colorado, United States
• Lynn Cancer Institute Center — Boca Raton, Florida, United States
• Holy Cross Hospital - Michael and Dianne Bienes CCC — Fort Lauderdale, Florida, United States
• Sylvester Comprehensive Cancer Center - University of Miami Health System — Miami, Florida, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• American Health Network of Indiana, LLC — Indianapolis, Indiana, United States
• Franciscan St. Francis Health Cancer Center — Indianapolis, Indiana, United States
• Baptist Health Lexington Oncology Associates — Lexington, Kentucky, United States
• University of Maryland - DUPLICATE/Pediatric Surgery — Baltimore, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Columbia University Medical Center — New York, New York, United States
• Hematology Oncology Center of Nyack Hospital — Nyack, New York, United States
• FirstHealth of the Carolinas, Inc. — Pinehurst, North Carolina, United States
• The James Cancer Hospital and Solove Research Institute — Columbus, Ohio, United States
• UPMC Cancer Center — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology — Houston, Texas, United States
• Sanatorio Allende — Córdoba, Argentina
• Centro Polivalente de Asistencia e Inv. Clinica CER — San Juan, Argentina
• Bendigo Hospital — Bendigo, Australia
• The Townsville Hospital — Douglas, Australia
• University of California Irvine Medical Center — Orange, California, United States

Full record on ClinicalTrials.gov

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