M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)
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.
Checked against the public recordLast updated Jan 16, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- EMD Serono Research & Development Institute, Inc.
- Interventions being studied
- Drug: M7824; Drug: Placebo; Drug: Durvalumab; Drug: Etoposide; Drug: Pemetrexed; Drug: Carboplatin; Drug: Paclitaxel; Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy (IMRT)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of California Irvine Medical CenterOrange, California
- UCLA Hematology Oncology - Main Site - 2020 Santa MonicaSanta Monica, California
- University of Colorado Health - Memorial Hospital - Memorial HospitalColorado Springs, Colorado
- Hematology Oncology AssociatesFort Collins, Colorado
- Lynn Cancer Institute CenterBoca Raton, Florida
- Holy Cross Hospital - Michael and Dianne Bienes CCCFort Lauderdale, Florida
- Sylvester Comprehensive Cancer Center - University of Miami Health SystemMiami, Florida
- The University of Chicago Medical CenterChicago, Illinois
- American Health Network of Indiana, LLCIndianapolis, Indiana
- Franciscan St. Francis Health Cancer CenterIndianapolis, Indiana
- Baptist Health Lexington Oncology AssociatesLexington, Kentucky
- University of Maryland - DUPLICATE/Pediatric SurgeryBaltimore, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 16, 2024. Always confirm current availability with the study team.