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Brief Title: Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combo With Durvalumab in Non-Small Cell Lung Cancer
Official Title: A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Study ID: NCT03419559
Brief Summary: This study is a Phase 2, open-label, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) in combination with Anti-PD-L1 inhibitor durvalumab.
Detailed Description: LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California San Diego, Moores Cancer Center, La Jolla, California, United States
University of California, Los Angeles, Santa Monica Hematology/Oncology, Los Angeles, California, United States
University of Louisville James Graham Brown Cancer Center, Louisville, Kentucky, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Morristown Medical Center Atlantic Hematology Oncology, Morristown, New Jersey, United States
UPMC Cancer Center, Pittsburgh, Pennsylvania, United States
Vanderbilt University, Nashville, Tennessee, United States
University of Washington Medical Center, Seattle, Washington, United States
Name: Iovance Medical Monitor
Affiliation: Iovance Biotherapeutics, Inc.
Role: STUDY_DIRECTOR