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Clinical TrialsExplore Clinical Research at Nashville General

Advancing healthcare through innovative research and community collaboration.

Find A Clinical Trial

Clinical Trials at NGH

Advancing medicine through compassionate research

Every medical breakthrough started with a simple question: "What if?" At NGH, our clinical trials program turns these questions into tomorrow's treatments, working hand-in-hand with a diverse patient population who share our vision for better healthcare.

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For Patients Your Journey Matters

Clinical trials aren't just research studies – they're opportunities to access innovative treatments while helping future generations from all walks of life. Our dedicated team guides you through every step, from your first question to your final visit.

What to Expect:

  • Personal support from our experienced research coordinators
  • Clear, concise explanations of your rights and options
  • Regular check-ups and careful monitoring
  • Access to new treatment options- The satisfaction of advancing medical knowledge
Who Should Consider a Clinical Trial?
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For Investigators Transform Patient Care Through Research

Join our community of healthcare pioneers. NGH supports your research vision with state-of-the-art facilities and comprehensive research support services.

We Provide:

  • Streamlined study startup processes
  • Dedicated research coordinator support from one of our compassionate team members
  • Access to diverse patient populations
  • Full regulatory compliance assistance
  • Industry-leading data management tools
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For Sponsors and Industry Partners Innovation Through Collaboration

Partner with NGH to advance your clinical research goals. Our experienced team delivers high-quality data, efficient recruitment, and exceptional study management.

Why Choose NGH:

  • Proven track record of successful trial completion
  • Robust quality data management systems
  • Experienced principal investigators across all disciplines
  • Dedicated study coordination teams of nurses and support staff
  • State-of-the-art imaging facilities and technology
Explore Partnership Opportunities

Clinical Trials

Disease Process NCT # Status Title Principal Investigator
BREAST CA HR+ (ER+ and/or PR+) / HER2- or HER2low advanced breast cancer (aBC) 07174336 Enrolling A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined with a CDK4/6 Inhibitor and Endocrine Therapy in Adults with HR+,

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined with a CDK4/6 Inhibitor and Endocrine Therapy in Adults with HR+, HER2- Advanced Breast Cancer with a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2

 Robin Jacob, MD
BREAST CA HR+ (ER+ and/or PR+) / HER2- or HER2low advanced breast cancer (aBC),TNBC 07211178 Enrolling GEMINI-BREAST: Evaluating Minimal Residual Disease (MRD) through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies Robin Jacob, MD
Cirrhosis Enrolling Case-Control Study of a Novel Test for the Early Detection of Hepatocellular Carcinoma in at-risk Patients with Cirrhosis
Sponsor: Curve Biosciences 		Benedict Maliakkal, MD
ER+, Her2- Metastatic Breast Cancer NCT0601673 Enrolling A Phase 3 Randomized, Open-Label study of op-1250 Monotherapy vs standard of care for the treatment of ER+, HER2- Advanced or Metastatic, breast cancer following endocrine and CDK 4/6 Inhibitor Therapy ( OPERA-01)

NCT06016738 Part 1 is closed. Part 2 opens March 2025.. This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.


Sponsor: Olema Pharmaceuticals, Inc. 		Robin Jacob, MD
Hepatocellular Carcinoma NCT06096779 Completed A Phase II, Open-Label, Multi-Cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis

The purpose of this study is to assess the safety and efficacy of atezolizumab and bevacizumab, or atezolizumab alone, as first-line treatment in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC) with Child-Pugh B7 or B8 cirrhosis.


Sponsor: Genentech, Inc. 		Robin Jacob, MD
MASH (Metabolic Dysfunction Associated Steatohepatitis) 07325526 Pending Double -blind, placebo controlled study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 3802876

Double -blind, placebo controlled study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 3802876 in participants with compensated cirrhosis due to Metabolic Dysfunction -Associated Steatohepatisis (Mash)

 Benedict Maliakkal, MD
Non Small Cell Lung cancer 06745882 Enrolling Community Outreach to Empower Black Patients with NSCLC to Improve Engagement and Awareness Robin Jacob, MD
NSCLC, Metastatic, STK11, KEAP1, KRAS mutations NCT06008093 Completed A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients (TRITON)

The purpose of the study is to assess the efficacy of durvalumab plus tremelimumab in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy in metastatic NSCLC patients with non-squamous histology who have mutations and/or co-mutations in STK11, KEAP1, or KRAS.  TRITON Trial


Sponsor: AstraZeneca 		Robin Jacob, MD
Triple Negative Breast Cancer NCT06393374 Completed Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.


Sponsor: Merck Sharp & Dohme LLC 		Robin Jacob, MD
Triple negative breast cancer , HR Low-Positive/HER2-Negative Breast cancer NCT06966700 Enrolling A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

Researchers are looking for new ways to treat types of breast cancer that are both:

  • High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment

  • Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.

    Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.

  • The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:
  • Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy
  • Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

Sponsor: Merck Sharp & Dohme LLC 		Robin Jacob, MD

Meet the Nashville General
Clinical Trials Team

Our Clinical Trials team at Nashville General Hospital is dedicated to advancing research and improving patient care. Led by experts in oncology, hepatology, population health, and clinical research, our team brings decades of experience in patient-centered studies, innovative treatments, and community engagement. Together, we ensure every trial is conducted with the highest standards of safety, integrity, and compassion.

image of presenter at ONS 50th Annual Congress

Nashville General Hospital presentation at the 50th Annual Oncology Nursing Society Congress in Denver, CO, April 2025

Dr. Debra Wujcik presented a poster at the 50th Annual Oncology Nursing Society Congress located in Denver CO showcasing the formation of the nursing oncology research program at Nashville General Hospital. The poster presentation, entitled "Establishing a Nurse-led Research Infrastructure in a Safety Net Community Hospital" illustrated how a nurse-led research infrastructure for clinical trials was established in September 2023 and emphasized the key elements of success as matching trials to patient populations and ongoing organizational education.

  • Presenter- Debra Wujcik, PhD, RN, Research Consultant, Nashville General Hospital
  • Co-authors: Faye Jornadal, RN, MSN, Cancer Program Coordinator, Cancer Registry Dept
  • Susan Owenby, RN, CCRP, Director, NGH Office of Research
  • Alecia Fair, DrPH, Chief, Population Health and Research Officer

Clinical Trials Articles

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Acknowledgement Notice

NOTE: Any publications or presentations resulting from collaboration with the Nashville General Hospital Office of Research must include the following acknowledgement: “This _____________ was supported by the Nashville General Hospital Office of Research . Its contents are solely the responsibilities of the authors and do not necessarily represent official views of Nashville General Hospital”

Contact the Clinical Trials Office

For more information contact the Office of Clinical Research:

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