Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Viola W Zhu

Description

Summary

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.

Official Title

A Multicenter, Double Blind, Randomized, Controlled Study of M7824 With Concurrent Chemoradiation Followed by M7824 Versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants With Unresectable Stage III Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer Bintrafusp alfa (proposed INN) M7824 Durvalumab Stage III INTR@PID LUNG 005 Lung Neoplasms Carcinoma, Non-Small-Cell Lung Paclitaxel Etoposide Carboplatin Pemetrexed Cisplatin Intensity Modulated Radiation Therapy (IMRT)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • University of California Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • UCLA Hematology Oncology - Main Site - 2020 Santa Monica accepting new patients
    Santa Monica California 90404 United States

Lead Scientist at UC Irvine

  • Viola W Zhu
    Associate Clinical Professor, Medicine. Authored (or co-authored) 35 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
EMD Serono Research & Development Institute, Inc.
Links
INTR@PID Clinical Trial Program Trial Awareness and Transparency website US Medical Information website, Medical Resources
ID
NCT03840902
Phase
Phase 2
Study Type
Interventional
Last Updated