June 4, 2020:

A randomized phase II Big Ten Cancer Research Consortium study for adults with stage I non-small cell lung cancer (NSCLC) will evaluate whether giving the monoclonal antibody pembrolizumab following surgical resection improves disease-free survival compared to observation following surgical resection in patients with primary tumors measuring 1-4 centimeters.

The multi-site study, BTCRC-LUN18-153, led by researchers at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center, is now open to accrual.

NSCLC is the most common form of lung cancer in the United States. Adults with early stage NSCLC typically undergo surgical resection and are observed afterward, if surgery is feasible. They may also undergo chemotherapy following surgery.

Previous NSCLC studies have demonstrated relapse rates ranging from 16-38% following surgical resection. While adjuvant chemotherapy has demonstrated increased disease-free survival and overall survival for patients with completely resected stage II and IIIA NSCLC, there is currently no evidence of improved outcomes for patients with completely resected stage I NSCLC with tumors less than 4 centimeters. Therefore, surgery alone remains the standard of care.

“Despite the fact that we have excellent surgeons resecting these tumors, and under the microscope the prognosis may look favorable, we are looking for better ways to reduce the number of patients who have their cancer return,” said Greg Durm, MD (pictured), sponsor-investigator of the study and a medical oncologist and researcher at the IU Simon Comprehensive Cancer Center. “Immunotherapy in the last several years has proven to be very effective in a number of forms of non-small cell lung cancer, so we would like to test pembrolizumab in stage I.”

Pembrolizumab is an immunotherapy drug that blocks the PD-1 pathway that cancer cells use to hide from the body’s immune system. Blocking the pathway helps the body’s immune system recognize and attack cancer cells. Pembrolizumab is approved by the U.S. Food and Drug Administration (FDA) to treat several types of cancer, including advanced NSCLC, but it has not been approved to treat stage I NSCLC, and should be considered investigational in this setting.

“Pembrolizumab is generally better tolerated than chemotherapy and there are fewer side effects for most patients,” Dr. Durm said. “We want to determine, by adding this treatment, whether we could avoid the toxicity of chemotherapy and also reduce the number of patients who have their cancer come back.”

Up to 368 people will take part in the study. Subjects will be randomized to one of two treatment groups, called arms. Each study participant will have an equal chance of being assigned to either arm. Subjects in Arm A will receive pembrolizumab once every three weeks following surgical resection for up to 17 cycles. Each cycle will last three weeks. Subjects in Arm B will be observed following surgical resection. Subjects may withdraw from the study at any point during the clinical trial in cooperation with their medical oncologist.

Blood, urine, and tissue will be collected during the clinical trial to support correlative research. Investigators want to determine whether the presence of circulating tumor DNA (ctDNA) or circulating tumor cells (CTCs) following surgical resection is a predictor for relapse, and whether ctDNA, CTCs, and certain biomarkers might predict which patients will benefit from pembrolizumab after surgery.

To qualify for this study, participants must be adults ages 18 and older with stage I non-small cell lung cancer, with tumors that have been completely removed and measure 1 to 4 centimeters.

This study is supported by Merck Sharp & Dohme Corp.

For more information about this research study, including full eligibility requirements, visit www.clinicaltrials.gov (study #NCT04317534).

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 more than 9,800 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.