Combined Epigenetic and Immunotherapy for Advanced Non-Small Cell Lung Cancer

Dr. Stephen Baylin, MD

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins UniversityView Bio

Stephen B. Baylin, MD, is deputy director of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and the Virginia and D.K. Ludwig professor of oncology and medicine. He is chief of the Cancer Biology Division and associate director for research of the center, and professor at the Van Andel Institute (VARI) to help lead its multi-institutional VARI-Stand Up to Cancer (SU2C) Epigenetics Dream Team.

Baylin attended Duke University, where he earned his medical degree in 1968 and completed his internship and first year residency in internal medicine. He then worked for two years at the National Heart and Lung Institute of the National Institutes of Health (NIH). In 1971, Baylin joined the departments of oncology and medicine at Johns Hopkins University School of Medicine.

His research interests include cellular biology and genetics of cancer, specifically epigenetics or genetic modifications other than those in DNA that can affect cell behavior, and silencing of tumor suppressor genes and tumor progression. His research has looked at the mechanisms through which variations in tumor cells derive, and cell differentiation in cancers such as medullary thyroid carcinoma and small cell lung carcinoma.

Baylin’s honors include the 2004 National Investigator of the Year Award from the NCI SPORE program; the 2005 Jack Gibson Visiting Professorship, University of Hong Kong Queen Mary Hospital, Hong Kong; the 2005 Shubitz Cancer Research Prize from the University of Chicago; the 2008 Raffaele Tecce Memorial Lecture, Rome, Italy; the 2008 David Workman Memorial Award from the Waxman Foundation; and the Kirk A. Landon-AACR Prize for Basic and Translational Cancer Research.

Baylin has served on the American Association for Cancer Research Board of Directors from 2004 through 2007, and is an associate editor of Cancer Research. He has also presented frequently at AACR conferences and chaired the special conference on “DNA Methylation, Imprinting and the Epigenetics of Cancer.” Baylin has authored or co-authored more than 350 publications.

Dr. Matthew P. Hellmann, MD

Memorial Sloan Kettering Cancer CenterView Bio

Matthew Hellmann, MD, is a medical oncologist, specializing in clinical trials and translational research related to immunotherapy for patients with lung cancers. He received his MD from Johns Hopkins University, completed his residency training at Massachusetts General Hospital, and oncology fellowship at Memorial Sloan Kettering Cancer Center.

View Full Team

Meet the Team

  • Stephen B. Baylin, MD, Johns Hopkins University
  • Matthew P. Hellmann, MD, Memorial Sloan Kettering Cancer Center
  • Peter A. Jones, PhD, DSc, Van Andel Research Institute
  • Hui Shen, PhD, Van Andel Research Institute
  • Hossein Borghaei, DO, MS, Fox Chase Cancer Center
  • Jarushka Naidoo, MBBCh, Johns Hopkins University
  • John E. Wherry, PhD, University of Pennsylvania
  • Scott Jewell, PhD, Van Andel Research Institute
  • Julie R. Brahmer, MD, John Hopkins University
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About This SU2C Catalyst Clinical Trial

Have you or a loved one been diagnosed with advanced non-small cell lung cancer (NSCLC)? Stand Up To Cancer (SU2C) is supporting a clinical trial that may benefit not only patients with NSCLC but potentially those with other cancer types as well.

Lung cancer begins when the cells of the lung become abnormal and begin to grow out of control. NSCLC develops as more cancer cells form into a tumor and spread to other areas of the body. The advent of immunotherapies offers new hope for more effective and safer strategies to treat cancer, particularly in patients with NSCLC.

What is immunotherapy?

The use of medicines to stimulate a person’s own immune system to recognize and destroy cancer cells more effectively.

What is epigenetic therapy?

The use of medicines to reprogram replicating cells to behave more like normal cells.

About 20 percent of patients with NSCLC who are treated with immunotherapies experience improvement, which demonstrates that immunotherapy can work in this disease. However, research from this clinical trial team shows that combining immunotherapy with epigenetic therapy may work even better than immunotherapy alone, and may improve the immune system’s response to cancer.

Through this clinical trial, the research team hopes to show that combining pembrolizumab (immunotherapy) with guadecitabine and mocetinostat (epigenetic therapies) will increase the number of patients who respond well to treatment. The team’s researchers believe that using this approach of cutting-edge science and clinical intervention will deliver improved treatments to patients with NSCLC.

We Need You

Why Your Participation Matters

This trial will help lay the groundwork for future studies that will confirm whether combining immunotherapies and epigenetic therapies will improve outcomes in patients with NSCLC, and whether this approach may also be applied to the treatment of other cancers.

Key Insights for Participants


Patients with confirmed diagnosis of advanced-stage NSCLC are eligible to enroll. There are additional criteria that must be met to participate, or that may prevent a patient from participating.

Key criteria are summarized below and can be found in detail on Interested patients will need to review their medical histories with clinical trial patient coordinators before they can be accepted to participate in this trial.

Female or Male
Age Range:
18 years or older
Advanced-stage NSCLC (who are resistant/refractory to prior PD-1 therapy)


Eligible participants must have received only the first line of treatment for advanced-stage lung cancer prior to participating in this study.

Eligible participants must not have previously received immunotherapy drugs as treatment for lung cancer.

Participants must have a tumor that can be biopsied as part of the research study before and during treatment.

Participants must have adequate organs function including lungs, heart, liver and kidney.


You play a vital role.

Here are the locations where you can currently participate in this clinical trial. If you or a loved one is interested in enrolling and learning more about this study, please contact the patient coordinator at your preferred site. The patient coordinator is there to help you understand every aspect of the clinical trial process and answer any questions you may have.

Once you contact the patient coordinator, he or she will start by reviewing your medical history with you to see whether you meet all the criteria to participate. The coordinator will then guide you through a review of the study and detailed “informed consent” documents that you are required to sign when you enroll in a clinical trial.

New York - New York

Memorial Sloan Kettering Cancer Center
Kathryn Arbour, MD
P: 646-449-1775

Baltimore - Maryland

Johns Hopkins University
Jarushka Naidoo, MBBCh
P: 410-550-2174

Philadelphia - Pennsylvania

Fox Chase Cancer Center
Hossein Borghaei, MS, DO
P: 215-214-4297


Support for this study comes from Merck.
Learn more about Merck +
Here are some links to organizations that provide more information about non-small cell lung cancer, and may also discuss patient support, treatment options, and current clinical trials.
LUNGevity +American Lung Association Lung Force +
For additional resources, please visit +

Find out if there's a trial for you. Reach out today.

Even if you do not meet the requirements for this trial, there may be other trials for you. Get started with the SU2C Clinical Trial Finder, a free and confidential cancer clinical trial matching and referral service.

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