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

Trial Status: Active

The main purpose of this study is 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.

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Lia Etheridge
Phone: 310-825-7174

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Rebecca Hudson
Phone: 410-328-4827

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: IN_REVIEW
Columbus
Ohio State University Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Trial Phase Phase II

Trial Type Treatment

Lead Organization
EMD Serono Research & Development Institute, Inc.

  • Primary ID MS200647_0005
  • Secondary IDs NCI-2019-03669, 2018-003265-34
  • Clinicaltrials.gov ID NCT03840902