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Study compares docetaxel with or without nivolumab in advanced non-small cell lung cancer

A new study led by researchers at the Indiana University Melvin and Bren Simon Cancer Center may help answer questions about the role of immunotherapy in combination with chemotherapy in treating lung cancer patients whose disease worsened after initial response to immunotherapy.

The randomized phase II study, known as HCRN LUN15-233, involves docetaxel (also known as Taxotere®) with or without nivolumab (also known as Opdivo®).

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. Nasser Hanna, MD, (pictured) is leading the study, along with co-investigators Laura Lourdes, MD; Shadia Jalal, MD; and Lawrence Einhorn, MD.

Radium-223 dichloride is already FDA-approved for use in metastatic prostate cancer that has become resistant to androgen deprivation therapy and has spread to the bone. It is not known at this time whether adding Radium-223 dichloride to androgen deprivation therapy could benefit patients. This study will help researchers to know whether this experimental approach is better, the same, or worse than the usual approach.

“The objective of this study is to see if continuing nivolumab beyond progression with the addition of chemotherapy would improve the survival for patients who would normally stop receiving immunotherapy and have chemotherapy alone,” said Dr. Lourdes. “We know that chemotherapy can only work for so long, so we are hoping to improve their survival.”

Nivolumab is an antibody that is being tested to see if it will allow the body’s immune system to work against tumor cells. 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. Nivolumab is an immunotherapy that blocks the PD-1 pathway. By blocking PD-1, it allows the human immune system to recognize and kill cancer cells.

Nivolumab is approved by the U.S. Food and Drug Administration (FDA) to treat lung, skin, and kidney cancers.

Docetaxel is approved by the FDA to treat breast, stomach, lung, prostate, and head and neck cancers. It is the standard therapy for patients who progress during treatment with nivolumab or other immunotherapy drugs.

While nivolumab and docetaxel are approved by the FDA in certain settings, continuing to give nivolumab after progression combined with docetaxel is considered “investigational.” This means the use of these drugs in this setting has not been approved by the FDA.

About 58 subjects will participate in the study, and will be randomized to one of two treatment arms. Arm A will receive docetaxel plus nivolumab, while Arm B will receive docetaxel alone. Patients on both arms will receive treatment every three weeks until their cancer worsens or they have severe side effects.

To enroll in HCRN LUN15-233, subjects must have advanced non-squamous non-small cell lung cancer with previous clinical benefit on treatment with single agent nivolumab. Tumor tissue obtained through excisional, incisional, or core needle biopsy prior to receiving single-agent nivolumab must be identified prior to registration and obtained during the screening period. Additional eligibility requirements must be met to enroll.

This trial is supported by Bristol-Myers Squibb.

For more information about this study, including full eligibility requirements, visit www.clinicaltrials.gov (study #NCT03041181).

About Hoosier Cancer Research Network:

Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) conducts innovative cancer research in partnership with academic and community physicians and scientists across the United States and internationally. 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 initiated more than 160 trials in a variety of cancer types and supportive care, resulting in more than 300 publications. More than 5,000 subjects have participated in Hoosier Cancer Research Network clinical trials.