A clinical trial from Keck Medicine of USC will test the feasibility of treating non-small cell lung cancer with immunotherapy provided at home.
Immunotherapy, medicines that use the body's immune system to eliminate or control cancer cells, are effective for many cancer patients, but are currently only administered intravenously (into the vein) in a doctor's office or hospital.
The study will examine if a new formulation of atezolizumab, an immunotherapy approved for treating certain types of non-small cell lung cancer, can instead be safely and effectively administered subcutaneously, meaning it is injected under the patient's skin, by a nurse at the patient's home, along with telemedicine appointments and remote monitoring through wearable trackers.
This will be the first clinical trial to test at-home administration of subcutaneous immunotherapy and could potentially lay the foundation for the future of at-home cancer care.
Many types of drugs are now being delivered subcutaneously at home for several conditions, and we hypothesize that this method of drug delivery can also be successful for cancer patients. Additionally, since COVID-19, we've learned that physicians have the digital tools to provide patients with excellent remote care."
Jorge Nieva, MD, medical oncologist and lung cancer specialist with Keck Medicine, member of USC Norris Comprehensive Cancer Center and lead investigator of the clinical trial
The benefits of at-home treatment
Lung cancer is the second most diagnosed cancer in the world and the leading cause of cancer deaths for both men and women worldwide. Non-small cell lung cancer accounts for 81% of all lung cancer cases in the United States.
Immunotherapy is a relatively new treatment option that has been approved to treat many cancer types both on its own or in combination with other therapies, such as radiation and chemotherapy.
Nieva believes that moving immunotherapy from a medical setting to the home will benefit patients. Patients will save time and energy traveling to a clinic or doctor's office, which can be especially difficult for those who are very sick, and they may feel more relaxed in their own homes. This could also potentially expand access to cancer treatment to patients who live in more remote areas or lack reliable access to transportation.
Delivering the drug under the skin rather than through an intravenous line (IV) has advantages as well.
"The procedure is easier and faster to administer and less likely to cause infection or complications, and patients avoid the potential discomfort of being stuck with a needle several times in the attempt to find a suitable vein for the IV," said Nieva.
Nieva was motivated to research at-home cancer treatments during the COVID-19 pandemic when a patient who was afraid of catching the virus died after he stopped going into the hospital for his cancer treatments.
"I realized we had to change the delivery of cancer care," said Nieva.
Clinical trial will use an immunotherapy consisting of monoclonal antibodies
The drug used in the clinical trial, atezolizumab, consists of a monoclonal antibody, a man-made protein that triggers the immune system to attack cancer cells. It was approved by the Food and Drug Administration in 2016 for late-stage lung cancer and more recently in 2021, for early stage, non-small cell lung cancer.
Investigators aim to enroll 37 patients with non-small cell lung cancer who are deemed eligible to receive immunotherapy as treatment. Patients will receive treatments administered by a nurse who will visit their home every three weeks for one to two years.
Additionally, Nieva and his colleagues will use the latest digital tools to track patients' vital signs, physical activity and other markers of health remotely and monitor patients with telehealth visits.
The study will not only examine the feasibility of home administration of the medication, but how well patients comply with the program and how satisfied they are with being treated remotely and through telehealth appointments.
Nivea hopes that the clinical trial will not only benefit patients with non-small cell lung cancer, but other cancer patients as well.
"Increasingly, health care is moving in a direction where instead of patients going to us for services, we are able to come to them, increasing access to care and potentially addressing existing health care disparities," said Nieva. "If this study can show that at-home cancer immunotherapy is safe and feasible for non-small cell lung cancer, it will open the door for more home treatments for other types of cancers in the future."
To learn more about the criteria to participate in the clinical trial, click here. Those who are interested in participating in the trial may contact Sandy Tran at (323) 865-3935 or [email protected].
The sponsors of the clinical trial are the National Cancer Institute (NCI), grant number ML43326, and Genentech, Inc.
Adding high-dose IV vitamin C to chemotherapy can boost survival for pancreatic cancer patients