May 26, 2017:

Lung cancer researchers at the Indiana University Melvin and Bren Simon Cancer Center have opened a clinical trial testing the effects of immunotherapy in combination with next-line chemotherapy in patients who experienced some benefit from immunotherapy before their disease worsened.

The single-arm phase II study, known as BTCRC-LUN15-029, will enroll about 35 subjects with advanced non-small cell lung cancer who were treated with a PD-1 (programmed death-1) or PD-L1 (programmed death-ligand 1) inhibitor and experienced either stable disease or a partial or complete response before their disease worsened.

The study is now open to accrual at the Indiana University Melvin and Bren Simon Cancer Center. Additional sites will open the study in the near future. Gregory A. Durm, MD, is leading the study, along with co-investigators Nasser Hanna, MD; Shadia Jalal, MD; and Lawrence Einhorn, MD.

“At the time patients begin to progress or their cancer recurs, our study will enroll them to see if continuing immunotherapy with the next line of therapy, which is typically chemotherapy, is of benefit to them,” Durm said. “As immunotherapy becomes more popular and we use it earlier on, the question remains: Should we stop it at progression or should we continue it at progression? That’s what this study will help answer.”

Lung cancer is the leading cause of cancer-related death in the United States. About 224,000 new cases of lung cancer were diagnosed in 2016, and about 158,000 people died from their disease. More than half of lung cancer patients are diagnosed when their disease has already metastasized, or spread to other parts of the body.

All subjects who enroll on the study will receive the immunotherapy drug Keytruda®, also known as pembrolizumab, in combination with one of three chemotherapy drugs of their doctor’s choosing: either decetaxel, pemetrexed, or gemcitabine.

How Keytruda works

The immune system sends out special cells called T cells to fight infections and diseases throughout the body. Some cancer cells can hide from T cells by taking control of a pathway called PD-1. This lets the cancer cells avoid an attack from T cells. Keytruda blocks this signal and allows the immune system to recognize and attack these cancer cells.

The use of Keytruda with chemotherapy when cancer has progressed after initially getting better while taking an immune therapy is investigational. This means Keytruda has not been approved by the U.S. Food and Drug Administration (FDA) for use in this setting. Keytruda has been approved by the FDA to treat patients with non-small cell lung cancer after they have progressed on chemotherapy.

This trial is supported by Merck Sharp & Dohme Corp.

For more information about this study, including full eligibility requirements, visit www.clinicaltrials.gov (study #NCT03083808).

About the Big Ten Cancer Research Consortium: The Big Ten Cancer Research Consortium was created in 2013 to transform the conduct of cancer research through collaborative, hypothesis-driven, highly translational oncology trials that leverage the scientific and clinical expertise of Big Ten universities. The goal of the Big Ten Cancer Research Consortium is to create a unique team-research culture to drive science rapidly from ideas to new approaches to cancer treatment. Within this innovative environment, today’s research leaders collaborate with and mentor the research leaders of tomorrow with the unified goal of improving the lives of all patients with cancer.

About the Big Ten Conference: The Big Ten Conference is an association of world-class universities whose member institutions share a common mission of research, graduate, professional and undergraduate teaching and public service. Founded in 1896, the Big Ten has sustained a comprehensive set of shared practices and policies that enforce the priority of academics in the lives of students competing in intercollegiate athletics and emphasize the values of integrity, fairness and competitiveness. The broad-based programs of the 14 Big Ten institutions will provide over $200 million in direct financial support to almost 9,500 students for more than 11,000 participation opportunities on 350 teams in 42 different sports. The Big Ten sponsors 28 official conference sports, 14 for men and 14 for women, including the addition of men’s ice hockey and men’s and women’s lacrosse since 2013. For more information, visit www.bigten.org.