RecruitingInterventionalPhase 2

A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (TIL or LN-145) in Patients With Metastatic Non-Small-Cell Lung Cancer

NCT ID: NCT04614103Sponsor: Iovance Biotherapeutics, Inc.Last updated: 2026-04-15

Summary

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

Detailed description

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.

Arms & interventions

BiologicalLN-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.
BiologicalLN-145
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.

Outcome measures

Primary

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

Secondary

Objective Response Rate
Time frame: Up to 60 months
Complete Response Rate
Time frame: Up to 60 months
Duration of Response
Time frame: Up to 60 months
Disease Control Rate
Time frame: Up to 60 months
Progression-Free Survival
Time frame: Up to 60 months
Overall Survival
Time frame: Up to 60 months
Adverse Events
Time frame: Up to 60 months
Core Biopsies
Time frame: Up to 60 months

Eligibility criteria

Sex: AllAge: 18 Years to 70 YearsHealthy volunteers: No

Inclusion Criteria: * Patients who are over 70 years of age may be allowed to enroll after discussion with the Medical Monitor. * Have historically or pathologically confirmed diagnosis of metastatic Stage IV NSCLC without EGFR, ALK, or ROS1 genomic alterations. * For patients who have actionable mutations (other than EGFR, ALK, or ROS1 genomic alterations), 1 additional line of therapy with the appropriate health authority approved targeted therapy is required. * Patients must have documented radiographic disease progression on or after the first-line therapy, including concurrent or sequential ICI and platinum-based chemotherapy ± bevacizumab. No more than 1 prior line is allowed if ICI and platinum-based chemotherapy were administered concurrently and no more than 2 prior lines are allowed for sequential administration of platinum-based chemotherapy and ICI as 2 separate lines. * LN-145 manufacture is allowed for patients who have residual resectable disease after completion of the platinum-based chemotherapy component of the front-line ICI and platinum-based chemotherapy combination and meet all eligibility criteria except documented disease progression. These patients must intend to receive TIL therapy after disease progression * Prior systemic therapy in the adjuvant or neoadjuvant setting, or as part of definitive chemoradiotherapy, will count as a line of therapy if the patient had disease progression during or within 12 months after the completion of such therapy. * At least 1 resectable lesion for TIL production and at least one remaining measurable lesion, as defined by RECIST v1.1 * Have adequate organ function * LVEF \> 45%, NYHA Class 1 * Have adequate pulmonary function * ECOG performance status of 0 or 1 * Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after all protocol-related therapy Exclusion Criteria: * Patients who have EGFR, ALK or ROS1 driver mutations * Patients who have symptomatic, untreated brain metastases. * Patients who have had allogeneic organ transplant or prior cell therapy within the past 20 years * Patients who have any form of primary immunodeficiency * Patients who are on systemic steroid therapy ≥ 10 mg/day of prednisone or equivalent. * Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment * Patients who have had another primary malignancy within the previous 3 years * Participation in another interventional clinical study within 21 days

Study locations (46)

Banner Health MD Anderson

Gilbert, Arizona, 85234

Recruiting

City of Hope

Duarte, California, 91010

Withdrawn

UC San Diego Moores Cancer Center

La Jolla, California, 92037

Withdrawn

University of Southern California

Los Angeles, California, 90033

Withdrawn

Christiana Care Health System

Newark, Delaware, 19713

Withdrawn

University of Florida Health Cancer Center

Gainesville, Florida, 32610

Withdrawn

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

Recruiting

AdventHealth Cancer Institute

Orlando, Florida, 32804

Withdrawn

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612

Recruiting

Augusta University

Augusta, Georgia, 30912

Recruiting

Rush University Medical Center

Chicago, Illinois, 60612

Withdrawn

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, 60612

Withdrawn

Advocate Aurora Health

Park Ridge, Illinois, 60068

Recruiting

University of Kentucky-Markey Cancer Center

Lexington, Kentucky, 40536

Recruiting

University of Louisville

Louisville, Kentucky, 40202

Recruiting

University of Maryland

Baltimore, Maryland, 21201

Recruiting

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Withdrawn

Karmanos Cancer Institute

Detroit, Michigan, 48201

Recruiting

Henry Ford Health System

Detroit, Michigan, 48202

Withdrawn

University of Minnesota

Minneapolis, Minnesota, 55455

Recruiting

University of Nebraska Medical Center

Omaha, Nebraska, 68198

Recruiting

MD Anderson Cooper

Camden, New Jersey, 08103

Withdrawn

Roswell Park Cancer Institute

Buffalo, New York, 14263

Withdrawn

New York University Langone Medical Center

New York, New York, 10016

Recruiting

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Withdrawn

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting

University of Rochester Medical Center

Rochester, New York, 14642

Withdrawn

University of North Carolina

Chapel Hill, North Carolina, 27514

Recruiting

Novant Health - Charlotte

Charlotte, North Carolina, 28204

Withdrawn

Novant Health - Winston-Salem

Winston-Salem, North Carolina, 27103

Recruiting

Atrium Health Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

Withdrawn

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58102

Recruiting

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219

Recruiting

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

Recruiting

University of Oklahoma

Oklahoma City, Oklahoma, 73104

Withdrawn

Oregon Health and Science University

Portland, Oregon, 97239

Recruiting

Allegheny General Hospital

Natrona Heights, Pennsylvania, 15065

Recruiting

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

Withdrawn

Sanford Cancer Center

Sioux Falls, South Dakota, 57102

Recruiting

Avera Medical Group Cancer Institute

Sioux Falls, South Dakota, 57105

Withdrawn

University of Tennessee Medical Center

Knoxville, Tennessee, 37920

Recruiting

Baptist Cancer Center

Memphis, Tennessee, 38120

Recruiting

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246

Withdrawn

Houston Methodist

Houston, Texas, 77030

Withdrawn

VCU Medical Center (Virginia Commonwealth University)

Richmond, Virginia, 23298

Recruiting

Seattle Cancer Care Alliance

Seattle, Washington, 98109

Recruiting