Aug. 16, 2019:

A clinical trial conducted by the Big Ten Cancer Research Consortium (Big Ten CRC) geared to adult patients with advanced Stage IV non-squamous non-small lung cancer will test how participants respond to a combined treatment therapy and how long the cancer can be controlled before it returns. The Big Ten CRC will also check toxicity levels in tissue and blood markers.

The multicenter, single-arm, phase II clinical trial, BTCRC-LUN17-139, led by Nasser H. Hanna, MD, at Indiana University Melvin and Bren Simon Cancer Center, will build on the foundation of chemotherapy and immunotherapy, and add antiangiogenic therapy, which is intended to block the formation of new blood vessels, to stop the growth of tumors.

Participants in the study will take four cancer-fighting drugs, including carboplatin and pemetrexed, which are standard chemotherapy drugs; atezolizumab, an immunotherapy drug that serves as a checkpoint inhibitor directed to the PD-L1 protein; and bevacizumab, an engineered monoclonal antibody that stabilizes the abnormal blood supply seen in untreated tumors.

Support is provided by Genentech.

The clinical trial is now open at Indiana University Melvin and Bren Simon Cancer Center, the University of Illinois Cancer Center, and the University of Wisconsin Carbone Cancer Center, and will expand to other Big Ten cancer centers.

Study co-investigator Adam Miller, MD, a former hematology-oncology fellow at Indiana University School of Medicine, said researchers are recognizing how inhibitors work, and are using them to stay a step ahead of cancer.

“The goal is to affect the tumor so that chemotherapy and immunotherapy can be delivered better, so that it can attack the cancer more effectively,” Dr. Miller said.

He said if they can improve treatment directed toward cancer cells, researchers are also hopeful that side effects will subside and the toxicity level will decrease, so patients can tolerate treatment better—and longer.

“If we get a good response from our patients and we are able to keep these cancers from growing and progressing,” Dr. Miller said, “we can continue these medications as long as our patients tolerate them.”

Non-small cell lung cancer (NSCLC) is a disease in which abnormal cells form in the tissues of the lung and accounts for most lung cancers. Standard treatment currently is surgery, chemotherapy, and immunotherapy.

Dr. Miller said there are several ways that cancer can evade the body’s immune system.

The cancer “almost puts a cloak on itself,” Dr. Miller said. “The body just can’t notice it and can’t find it. When we use immunotherapy, we are able to find some targets that are on these cancer cells that are stopping the process of our own body’s system. Immunotherapy is really allowing the body to fight cancer by itself.”

To fight infections and diseases throughout one’s body, the immune system produces T-cells. However, a protein called PD-L1, which is present in some cancer cells, allows cancer cells to turn off an attack from T-cells. By using immunotherapy, doctors may be able to fight the cancer more effectively.

Dr. Miller said when combining immunotherapy, antiangiogenic therapy, and chemotherapy, researchers can stabilize the environment. The addition of bevacizumab, which is an antiangiogenic medication, stabilizes the abnormal blood supply seen in untreated tumors.

“We are able to deliver the chemotherapy that is going to be toxic to the cancer and deliver the immune system’s own cells, so they are able affect the cancer,” Dr. Miller said. “We know that we are a little more effective if we can control that environment. “So really, we are controlling the highway. We are controlling the flow of treatment to the cancer cells.”

Up to 46 people can participate in this clinical trial. Participants will each receive the four drugs intravenously every three weeks for up to four cycles. Subjects who respond well may continue with maintenance therapy. All four drugs have been approved by the U.S. Food & Drug Administration for different uses, but together are considered investigational.

The study is open to adults, ages 18 and above, who have Stage IV NSCLC or recurrent disease.

For more information about this research study, including full eligibility requirements, visit (study #NCT03713944).

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