A multi-institutional single-arm study led by Rachel Sanborn, MD, of the Earle A. Chiles Research Institute, a division of Providence Cancer Institute, is testing the immunotherapy drug durvalumab followed by chemoradiation and consolidation durvalumab for adults with previously untreated stage III non-small cell lung cancer (NSCLC).

The study, HCRN LUN18-357, is currently enrolling participants at Providence Cancer Institute in Portland, Oregon; HealthPartners Institute in Minneapolis; Rush University Medical Center in Chicago; Summit Health Cancer Center in Florham Park, New Jersey; and Cancer Center of Kansas in Wichita.

Researchers will estimate progression-free survival (PFS), the percent of study participants whose cancer has not worsened, at 12 months after completion of chemoradiation. Researchers will compare these results against historical controls from a prior study to learn if this approach might warrant further investigation.

The current standard treatment for patients with unresectable stage III NSCLC is chemoradiation followed by consolidation durvalumab for 12 months. However, more than 22 percent of patients who receive standard treatment will experience new lesions and disease recurrence.

“The study that we’re conducting is looking at whether adding a dose of immunotherapy before the chemotherapy and radiation begins will be more effective at helping the immune system recognize and control the cancer,” said Dr. Sanborn.

Durvalumab is a monoclonal antibody that blocks the PD-1/PD-L1 pathway, which cancer cells often use to evade the body’s immune system. By blocking this pathway, durvalumab helps the immune system recognize and attack cancer cells.

The U.S. Food and Drug Administration (FDA) has approved durvalumab for use in certain bladder and lung cancers, including unresectable stage III NSCLC following chemoradiation. However, the use of durvalumab before chemoradiation in previously untreated stage III NSCLC has not been FDA approved and should be considered investigational.

Study participants, also called subjects, will begin treatment with one cycle of induction durvalumab (given on Day 1 of the cycle; a cycle lasts 4 weeks). Standard chemoradiation therapy will begin 4-5 weeks after receiving induction durvalumab. Subjects whose cancer has not worsened after chemoradiation will receive consolidation durvalumab on Day 1 of each treatment cycle, for up to 12 cycles. Researchers will take imaging scans every three cycles. Subjects may continue on the study until their cancer starts to worsen. Subjects may also withdraw from the study at any time and for any reason, in consultation with their doctor.

Blood, tissue, and stool samples will be collected to support correlative objectives for this study. Correlative research helps investigators better understand why some patients respond to treatment and others do not. This valuable knowledge helps researchers develop follow-up studies that can ultimately leader to safer and more effective treatments for patients.

The study will enroll up to 54 participants. To qualify, participants must be age 18 or older with previously untreated stage III NSCLC. Other criteria must be met to enroll in this study.
The study is supported by AstraZeneca.

For more information about this research study, including full eligibility requirements, visit www.clinicaltrials.gov (study #NCT04364048).

About Hoosier Cancer Research Network 

Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) conducts innovative cancer research in collaboration with academic and community physicians and scientists across the United States. The organization provides comprehensive clinical trial management and support, from conception through publication. Created in 1984 as a program of the Walther Cancer Institute, Hoosier Cancer Research Network became an independent nonprofit clinical research organization in 2007. Since its founding, Hoosier Cancer Research Network has conducted more than 230 trials in a variety of cancer types and supportive care, resulting in more than 350 publications. More than 9,000 subjects have participated in Hoosier Cancer Research Network clinical trials.