Clinical Trials

UAMS Contributes to Groundbreaking Lung Cancer Clinical Trial

The long-awaited results of a 10-year lung cancer clinical trial that UAMS contributed to were recently published in the New England Journal of Medicine.

UAMS was one of 83 centers in the United States and Canada that participated in the National Cancer Institute-funded trial that showed patients with early-stage lung cancer can be treated with sublobar resection rather than the more aggressive lobectomy surgery.

“We are always looking for ways to make lung cancer surgeries safer and less invasive,” said Matthew Steliga, M.D., chief of thoracic surgery at UAMS and one of 125 surgeons allowed to enroll patients in the Phase 3 study. “Until now, the standard of care for early lung cancer was to remove the whole lobe so we could get the lymph nodes and the roots of that part of the lung. It was the only proven way we could get all the cancer.”

A 1995 study by the Lung Cancer Study Group reported that local recurrence was three times as high with sublobar resection as with lobectomy and lung cancer-related mortality was 50% higher with sublobar resection. These results established lobectomy as the standard of surgical care for patients with new, early-stage non-small cell lung cancer.

Lung cancer is the leading cause of cancer deaths in Arkansas, more than breast, colon and prostate cancer combined.

Advances in imaging and staging methods have allowed physicians to detect smaller tumors in the lung earlier, so sublobar resection needed to be studied again.

A sublobar resection involves removing only a small wedge of the lung, less than two centimeters. Only patients with primary lung cancer where the cancer is present in the lung and nowhere else in the body are eligible for the less aggressive surgery.

“We know that we can get a good outcome without taking out the whole lobe now,” said Steliga. “Instead, we remove smaller, more select blood vessels and preserve what’s left of the healthy lung tissue. This improves pulmonary function and overall quality of life for the patient.”

A leader in robotic surgery, UAMS already performs minimally invasive lobectomies for patients with advanced lung cancer. Sublobar resection is not a new surgical technique for UAMS thoracic surgeons. The technique has also been performed on patients with limited pulmonary function who are too fragile for a lobectomy.

As lung cancer often does not show symptoms until more advanced stages, low dose CT screening is currently the only method of detecting early-stage lung cancer — the only stage in which patients have the sublobar resection option.

“For such a prevalent cancer, lung cancer screening is underutilized compared to mammography, which has been around for decades,” said Steliga. “Other cancers are caught early with great treatment options. Most people who are eligible for lung cancer screening don’t get screened.”

Adults ages 50 to 80 with who have smoked a pack a day for the last 20 years or two packs a day for 10 years are eligible for lung cancer screening, which is also offered at UAMS along with a comprehensive smoking cessation program.

While smoking is the primary risk factor for lung cancer, so is age.

“We know that a good number of people with lung cancer have not smoked,” said Steliga. “As we get older, tumors can generate due to the wear and tear on our bodies.”

That’s why Steliga is involved in an effort at UAMS to find better ways to detect lung cancer besides X-rays.

Referred to as the liquid biopsy, Steliga works closely with Donald Johann Jr., M.D., a UAMS Biomedical Informatics professor and federally funded cancer researcher, to collect and study blood samples of UAMS patients with lung cancer to find circulating tumor DNA, a common biomarker for cancer.

“Dr. Johann is a real leader in the country in blood test detection of lung cancer. It’s still in the research phase, and it will take years to mature into a fully validated test, but we will be able to determine if a person’s cancer has returned from a simple blood test.”

“It’s incredible, groundbreaking research,” said Steliga. “Someday, patients will ask how their blood work looks instead of their X-rays.”

Can a Second Chemotherapy Drug in Addition to Standard Radiation and Temozolomide Extend Your Life or Prevent the Growth and Spread of Your Brain Tumor?

NRG-BN011 is a clinical study for people with a type of brain tumor called a glioblastoma that have not yet received treatment other than surgery for their disease. Participants in this trial will need to be tested to see if their tumor has a biomarker called “methylated” MGMT. A biomarker gives information about how the tumor may respond to treatment. The MGMT methylation test helps predict if the tumor will respond to temozolomide, the standard chemotherapy drug used for glioblastomas. MGMT methylated tumors are more likely to respond to temozolomide chemotherapy.

NRG-BN011 will test to see if the addition of a second chemotherapy drug called lomustine to the usual treatment of radiation and temozolomide chemotherapy can help extend your life or stabilize your cancer. Lomustine is currently approved by the Food and Drug Administration (FDA)- to treat brain tumors, however, it is usually used for recurrent tumors. Researchers are doing this study to find out if this approach is better, the same, or worse than the usual approach for your brain tumor.

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Does adding a study drug to usual therapy after radical prostatectomy delay the spread of prostate cancer?

NRG-GU008, also known as the “INNOVATE” study, is a clinical study for patients who have node-positive prostate cancer and need more treatment after prostatectomy. This trial compares the usual treatment of hormone therapy and radiation therapy, to apalutamide added to the usual treatment. The addition of apalutamide to the usual treatment could stabilize your cancer and prevent it from spreading. This study will help doctors learn if this different approach is better, the same, or worse than the usual approach.To decide if it is better, the study doctors will be looking to see if the study approach increases the time without prostate cancer spreading compared to the usual approach.The study drug, apalutamide, is already approved by the FDA for use in advanced prostate cancer; however, most of the time apalutamide is not used until hormone drugs stop working and after prostate cancer has spread..

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Phase 1 Clinical Trial Tests Monoclonal Antibody + PD-1 Inhibitor

The Winthrop P. Rockefeller Cancer Institute is enrolling patients in its newly established Phase 1 Cancer Clinical Trials Unit. We’ve recently opened a novel clinical trial sponsored by Jounce Therapeutics, titled: “Phase 1 First-in-Human (FIH) Study of Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2) Inhibitor Monoclonal Antibody (mAb) JTX-8064, as Monotherapy and in Combination with a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, in Adult Subjects with Advanced Refractory Solid Tumor Malignancies.”

Led by Michael Birrer, M.D., Ph.D., Cancer Institute director, this study will bring a novel approach of harnessing the body’s immune system to treat cancer patients who have failed multiple lines of chemo and immunotherapies. The Cancer Institute is currently enrolling ovarian, breast, lung, and head and neck cancer patients to benefit future treatment options. Questions? mrkovak@uams.edu.

National Breast Cancer Screening Trial

Gwendolyn Bryant-Smith, M.D., chief of breast imaging at UAMS and local principal investigator for the trial

The UAMS Winthrop P. Rockefeller Cancer Institute is participating in the National Cancer Institute’s TMIST (Tomosynthesis Mammographic Imaging Screening Trial).

The study compares two standard breast cancer screening methods: tomosynthesis (3D) mammograms and digital (2D) mammograms, and is designed to help researchers determine whether one method is better than the other at finding life-threatening breast cancers.

The study involves 100 clinics and includes 165,000 women in the United States and Canada. The UAMS Breast Center has enrolled 290 participants to date and is able to include even more women.

“By participating in this research study, you can help determine the most effective type of mammogram and how often women should receive screening,” said Gwendolyn Bryant-Smith, M.D., chief of breast imaging at UAMS and local principal investigator for the trial.

In a briefing held Oct. 7, NCI leaders stated, “We need women to take part to make sure breast cancer screening of the future is appropriate for all women. October is Breast Cancer Awareness Month, a time to share the importance of screening mammograms and early detection.”

The UAMS TMIST study coordinator is available at (501) 400-3195 or TMISTstudy@uams.edu for anyone wanting to learn more about the study.

Women ages 45 to 74 who plan to get a routine screening mammogram at the UAMS Breast Center are eligible for this trial. Participants are randomly assigned to get either a 3D or 2D mammogram every one or two years for the first five years of the study. Researchers will follow each woman’s breast cancer status for a total of eight years by reviewing medical records and possibly conducting phone interviews.

TMIST was developed by the Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network (ECOG-ACRIN) Cancer Research Group and the National Cancer Institute, part of the National Institutes of Health. ECOG-ACRIN leads the trial.