This is a prospective, open-label, multi-cohort, non-randomized, multicenter phase 2 study evaluating LN-145 in patients with metastatic non-small-cell lung cancer
LN-145 is a ready-to-infuse TIL therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI and further optimized by Iovance for the treatment of patients with metastatic NSCLC. The cell transfer therapy used in this study involves patients receiving a non-myeloablative (NMA) lymphodepleting preparative regimen, followed by infusion of autologous TIL, then finally followed by the administration of IL-2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, patient is infused with autologous TIL (LN-145), followed by IL-2.
A tumor sample is obtained by image-guided core biopsy from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, patient is infused with autologous TIL (LN-145) followed by IL-2.
Objective Response Rate
To evaluate the efficacy of LN-145 as determined by objective response rate (ORR) in patients with metastatic NSCLC using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as assessed by central review for Cohorts 1 and 2 and by the investigator for Cohorts 3, 4 and the Retreatment Cohort
Time frame: Up to 60 months
Objective Response Rate
To evaluate the efficacy of LN-145 as determined by objective response rate (ORR) per RECIST v1.1, as assessed by the Investigator for Cohorts 1 and 2
Time frame: Up to 60 months
Complete Response Rate
To evaluate efficacy parameters such as Complete Response Rate (CRR) per RECIST v1.1
Time frame: Up to 60 months
Duration of Response
To evaluate efficacy parameters such as Duration of Response (DOR) rate per RECIST v1.1
Time frame: Up to 60 months
Disease Control Rate
To evaluate efficacy parameters such as Disease Control Rate (DCR) per RECIST v1.1
Time frame: Up to 60 months
Progression-Free Survival
To evaluate efficacy parameters such as Progression-Free Survival (PFS) per RECIST v1.1
Time frame: Up to 60 months
Overall Survival
To evaluate efficacy parameters such as Overall Survival (OS)
Time frame: Up to 60 months
Iovance Biotherapeutics Study Team lungcelltherapy.com
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City of Hope
Duarte, California, United States
WITHDRAWNUC San Diego Moores Cancer Center
La Jolla, California, United States
WITHDRAWNUniversity of Southern California
Los Angeles, California, United States
WITHDRAWNChristiana Care Health System
Newark, Delaware, United States
WITHDRAWNUniversity of Florida Health Cancer Center
Gainesville, Florida, United States
WITHDRAWNSylvester Comprehensive Cancer Center
Miami, Florida, United States
RECRUITINGAdventHealth Cancer Institute
Orlando, Florida, United States
WITHDRAWNH Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
RECRUITINGAugusta University
Augusta, Georgia, United States
RECRUITINGRush University Medical Center
Chicago, Illinois, United States
WITHDRAWN...and 74 more locations
Adverse Events
To characterize the safety profile of LN-145 in patients with non-small-cell lung cancer (NSCLC)
Time frame: Up to 60 months
Core Biopsies
To determine the feasibility of generating LN-145 using tumor tissue obtained via image-guided core biopsy
Time frame: Up to 60 months