A Phase 2 interventional study of LN-145 and LN-145 in Metastatic Non Small Cell Lung Cancer, sponsored by Iovance Biotherapeutics, Inc.. Recruiting at 71 sites in 12 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Iovance Biotherapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 170 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Iovance Biotherapeutics, Inc. is the lead sponsor of 16 studies on the registry; 8 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients whose tumors did not express programmed cell death-ligand 1 (PD-L1), i.e., tumor proportion score (TPS) \< 1% prior to ICI treatment and Patients with no available historical TPS for PD-L1 expression
Biological: LN-145
Patients whose tumors expressed PD-L1 TPS ≥1% prior to ICI treatment
Biological: LN-145
Patients, regardless of tumor PD-L1 TPS prior to ICI treatment, who are unable to safely undergo a surgical tumor resection for TIL generation
Biological: LN-145
Patients, regardless of tumor PD-L1 expression status prior to ICI treatment, who have meet all inclusion/exclusion criteria except the requirement to have documented disease progression may elect to have the tumor harvest procedure and TIL production prior to disease progression on their current anticancer treatment. Documentation of progressive disease and identification of a target lesion for RECIST v1.1 assessment is required at Baseline for these patients.
Biological: LN-145
Patients who were previously treated with LN-145 in Cohort 1, 2, 3, or 4.
Biological: LN-145
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.
Also known as: TIL, Autologous Tumor Infiltrating Lymphocytes
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.
Also known as: TIL, Autologous Tumor Infiltrating Lymphocytes
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
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
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Carcinoma, Non-Small-Cell Lung→
Iovance Biotherapeutics, Inc.