Status:
TERMINATED
M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
EMD Serono Research & Development Institute, Inc.
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 fol...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2023
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT03840902
Start Date
April 16 2019
End Date
February 17 2023
Last Update
January 16 2024
Active Locations (104)
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1
University of California Irvine Medical Center
Orange, California, United States, 92868
2
UCLA Hematology Oncology - Main Site - 2020 Santa Monica
Santa Monica, California, United States, 90404
3
University of Colorado Health - Memorial Hospital - Memorial Hospital
Colorado Springs, Colorado, United States, 80909
4
Hematology Oncology Associates
Fort Collins, Colorado, United States, 80528