Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer
NCT ID: NCT04614103
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
170 participants
INTERVENTIONAL
2021-05-07
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
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
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.
Cohort 2
Patients whose tumors expressed PD-L1 TPS ≥1% prior to ICI treatment
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.
Cohort 3
Patients, regardless of tumor PD-L1 TPS prior to ICI treatment, who are unable to safely undergo a surgical tumor resection for TIL generation
LN-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.
Cohort 4
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.
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.
Retreatment Cohort
Patients who were previously treated with LN-145 in Cohort 1, 2, 3, or 4.
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.
Interventions
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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.
LN-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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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Iovance Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Iovance Biotherapeutics Study Team
Role: STUDY_DIRECTOR
Iovance Biotherapeutics
Locations
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City of Hope
Duarte, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
Christiana Care Health System
Newark, Delaware, United States
University of Florida Health Cancer Center
Gainesville, Florida, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
AdventHealth Cancer Institute
Orlando, Florida, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Augusta University
Augusta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, United States
Advocate Aurora Health
Park Ridge, Illinois, United States
University of Kentucky-Markey Cancer Center
Lexington, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
MD Anderson Cooper
Camden, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
New York University Langone Medical Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Novant Health - Charlotte
Charlotte, North Carolina, United States
Novant Health - Winston-Salem
Winston-Salem, North Carolina, United States
Atrium Health Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Allegheny General Hospital
Natrona Heights, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Sanford Cancer Center
Sioux Falls, South Dakota, United States
Avera Medical Group Cancer Institute
Sioux Falls, South Dakota, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Baptist Cancer Center
Memphis, Tennessee, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Houston Methodist
Houston, Texas, United States
VCU Medical Center (Virginia Commonwealth University)
Richmond, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Hollywood Private Hospital Ramsay
Nedlands, Western Australia, Australia
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, , Canada
Princess Margaret Cancer Centre
Toronto, , Canada
Institut Paoli Calmettes
Marseille, , France
CHU Nantes
Nantes, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Universitätsklinikum Bonn
Bonn, , Germany
Universitätsklinikum Carl Gustav Carus, MK I
Dresden, , Germany
Universitätsklinikum Mannheim
Mannheim, , Germany
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, , Italy
IRCCS Fondazione del Piemonte per l'Oncologia
Piemonte, , Italy
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, , Netherlands
National Cancer Centre Singapore
Singapore, , Singapore
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
Gachon Unversity Gil Medical Center
Incheon, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
Hospital Universitario A Coruña
A Coruña, , Spain
Instituto Oncologico Rosell
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
C.H. Regional Reina Sofia
Córdoba, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Clinical Universitaria de Navarra
Pamplona, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Consorcio Hospital General Universitario de Valencia
Valencia, , Spain
Centre Hospitalier Universitaire Vaudois Lausanne
Lausanne, Canton of Vaud, Switzerland
University Hospital of Zurich/ Universitätsspital Zürich
Zurich, , Switzerland
Royal Marsden Hospital
Chelsea, England, United Kingdom
Sarah Cannon Research Institute
London, England, United Kingdom
University College London
London, England, United Kingdom
The Christie NHS Foundation Trust
Manchester, England, United Kingdom
Guy's Hospital
London, , United Kingdom
Countries
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Central Contacts
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Iovance Biotherapeutics Study Team lungcelltherapy.com
Role: CONTACT
Phone: 1-844-845-4682
Email: [email protected]
Other Identifiers
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2020-003629-45
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-510778-26-00
Identifier Type: CTIS
Identifier Source: secondary_id
IOV-LUN-202
Identifier Type: -
Identifier Source: org_study_id