The purpose of this study is to find out whether an investigational product, called LN-145, is safe and effective in the treatment of patients with Non-Small-Cell Lung Cancer (NSCLC). LN-145 is created by modifying your own cells and delivering them back in an infusion. This study is being sponsored by Iovance Biotherapeutics.
You will be screened, which may occur over multiple visits. Procedures will be done to see if you are a good fit for the study and if you can continue to the tumor harvest visit. Blood and urine will be collected for routine testing. If you meet the requirements, you will be moved forward to a visit to remove a piece or pieces of your tumor. Your eligibility to continue to receive the LN-145 will be assessed during the next phase of the study which can last between 1 and 12 months after your tumor harvest visit and may occur over multiple visits. If your tumor-infiltrating cells are growing and able to produce the LN-145, you will move on to next steps of pre-conditioning chemotherapy where we'll continue to assess your eligibility, The study treatment period starts at your pre-conditioning chemotherapy treatment. This period consists of 9 to 10 days of study therapy. Then, you will receive a single dose of LN-145 by IV infusion followed by up to 6 doses of IL-2 by IV infusion over the course of the next 1 to 4 days. You will be in the hospital for the LN-145 and IL-2 infusions, and you may remain in the hospital until the study doctor decides you can go home. We will continue to follow you for up to 5 years.
Reimbursement for parking, meals and travel (hotel, mileage, and long distance travel)
Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA
Jared Weiss
LCCC - Clinical Trials
Clinical or Medical
Interventional
Cancer (Lung)
21-0457