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TerminatedPhase 2NCT03840902
Official study title

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

Study 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 followed by durvalumab.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedM7824 and Placebo

Plus 7 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 16, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?104 U.S. locations

Locations may change over time.

Who runs it?EMD Serono Research & Development Institute, Inc.

Study sponsor

01
Study overview

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)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→Locally advanced→
Treatment approach
Immunotherapy→Chemotherapy→Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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.

04
Study sites

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.

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