Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer

April 10, 2026 updated by: Iovance Biotherapeutics, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • St. Vincent's Hospital
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Hollywood Private Hospital Ramsay
  • Canada
      • Montreal, Canada, QC H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
      • Toronto, Canada, M5G 2C1
        • Withdrawn
        • Princess Margaret Cancer Centre
  • France
      • Marseille, France, 13009
        • Recruiting
        • Institut Paoli Calmettes
      • Nantes, France, 44093
        • Recruiting
        • Chu Nantes
      • Nice, France, 06001
        • Recruiting
        • CHU Nice
      • Pierre-Bénite, France, 69310
        • Recruiting
        • Centre Hospitalier Lyon Sud
      • Poitiers, France, 90577
        • Recruiting
        • CHRU de Poitiers La Miletrie
      • Villejuif, France, 94805
        • Recruiting
        • Gustave Roussy Cancer Campus
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Charite- Universitätsklinikum Berlin
      • Bonn, Germany, 53127
        • Recruiting
        • Universitätsklinikum Bonn
      • Dresden, Germany, 01307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus, MK I
      • Mannheim, Germany, 68167
        • Recruiting
        • Universitätsklinikum Mannheim
  • Italy
      • Florence, Italy, 50134
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo di Pavia
      • Pesaro, Italy, 61122
        • Recruiting
        • Azienda Ospedaliera Ospedali Riuniti Marche Nord
      • Piemonte, Italy, 10060
        • Recruiting
        • IRCCS Fondazione del Piemonte per l'Oncologia
  • Netherlands
      • Amsterdam, Netherlands, 1066
        • Recruiting
        • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
  • Singapore
      • Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore
  • South Korea
      • Incheon, South Korea, 21565
        • Recruiting
        • Gachon Unversity Gil Medical Center
      • Seoul, South Korea, 3722
        • Recruiting
        • Severance Hospital, Yonsei University
    • Gangnam-gu
      • Seoul, Gangnam-gu, South Korea, 6351
        • Recruiting
        • Samsung Medical Center
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Hospital Universitario A Coruna
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08028
        • Recruiting
        • Instituto Oncologico Rosell
      • Córdoba, Spain, 14004
        • Recruiting
        • C.H. Regional Reina Sofia
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal
      • Málaga, Spain, 29016
        • Recruiting
        • Hospital Regional Universitario de Malaga
      • Pamplona, Spain, 31008
        • Recruiting
        • Clinical Universitaria de Navarra
      • Salamanca, Spain, 90577
        • Recruiting
        • Hospital Universitario de Salamanca
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain, 46014
        • Recruiting
        • Consorcio Hospital General Universitario de Valencia
  • Switzerland
      • Zurich, Switzerland, 8091
        • Withdrawn
        • University Hospital of Zurich/ Universitätsspital Zürich
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Switzerland, 1011
        • Recruiting
        • Centre Hospitalier Universitaire Vaudois Lausanne
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's Hospital
    • England
      • Chelsea, England, United Kingdom, SW36JJ
        • Recruiting
        • Royal Marsden Hospital
      • London, England, United Kingdom, W1G 6AD
        • Recruiting
        • Sarah Cannon Research Institute
      • London, England, United Kingdom, WC1E 68T
        • Recruiting
        • University College London
      • Manchester, England, United Kingdom, M10 4BX
        • Recruiting
        • The Christie NHS Foundation Trust
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner Health MD Anderson
    • California
      • Duarte, California, United States, 91010
        • Withdrawn
        • City of Hope
      • La Jolla, California, United States, 92037
        • Withdrawn
        • UC San Diego Moores Cancer Center
      • Los Angeles, California, United States, 90033
        • Withdrawn
        • University of Southern California
    • Delaware
      • Newark, Delaware, United States, 19713
        • Withdrawn
        • Christiana Care Health System
    • Florida
      • Gainesville, Florida, United States, 32610
        • Withdrawn
        • University of Florida Health Cancer Center
      • Miami, Florida, United States, 33136
        • Recruiting
        • Sylvester Comprehensive Cancer Center
      • Orlando, Florida, United States, 32804
        • Withdrawn
        • AdventHealth Cancer Institute
      • Tampa, Florida, United States, 33612
        • Recruiting
        • H Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Withdrawn
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60612
        • Withdrawn
        • University of Illinois Hospital & Health Sciences System
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Advocate Aurora Health
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky-Markey Cancer Center
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Withdrawn
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48202
        • Withdrawn
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Withdrawn
        • MD Anderson Cooper
    • New York
      • Buffalo, New York, United States, 14263
        • Withdrawn
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10029
        • Withdrawn
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10016
        • Recruiting
        • New York University Langone Medical Center
      • Rochester, New York, United States, 14642
        • Withdrawn
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Withdrawn
        • Novant Health - Charlotte
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Novant Health - Winston-Salem
      • Winston-Salem, North Carolina, United States, 27157
        • Withdrawn
        • Atrium Health Wake Forest University Health Sciences
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Recruiting
        • Sanford Roger Maris Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Withdrawn
        • University of Oklahoma
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
    • Pennsylvania
      • Natrona Heights, Pennsylvania, United States, 15065
        • Recruiting
        • Allegheny General Hospital
      • Philadelphia, Pennsylvania, United States, 19111
        • Withdrawn
        • Fox Chase Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57102
        • Recruiting
        • Sanford Cancer Center
      • Sioux Falls, South Dakota, United States, 57105
        • Withdrawn
        • Avera Medical Group Cancer Institute
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • University of Tennessee Medical Center
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Cancer Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Withdrawn
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
      • Houston, Texas, United States, 77030
        • Withdrawn
        • Houston Methodist
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Medical Center (Virginia Commonwealth University)
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
Other Names:
  • TIL, Autologous Tumor Infiltrating Lymphocytes
Biological: 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 Names:
  • TIL, Autologous Tumor Infiltrating Lymphocytes
Experimental: Cohort 2
Patients whose tumors expressed PD-L1 TPS ≥1% prior to ICI treatment
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.
Other Names:
  • TIL, Autologous Tumor Infiltrating Lymphocytes
Biological: 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 Names:
  • TIL, Autologous Tumor Infiltrating Lymphocytes
Experimental: 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
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.
Other Names:
  • TIL, Autologous Tumor Infiltrating Lymphocytes
Biological: 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 Names:
  • TIL, Autologous Tumor Infiltrating Lymphocytes
Experimental: 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.
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.
Other Names:
  • TIL, Autologous Tumor Infiltrating Lymphocytes
Biological: 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 Names:
  • TIL, Autologous Tumor Infiltrating Lymphocytes
Experimental: Retreatment Cohort
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.
Other Names:
  • TIL, Autologous Tumor Infiltrating Lymphocytes
Biological: 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 Names:
  • TIL, Autologous Tumor Infiltrating Lymphocytes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: Up to 60 months
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
Up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: Up to 60 months
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
Up to 60 months
Complete Response Rate
Time Frame: Up to 60 months
To evaluate efficacy parameters such as Complete Response Rate (CRR) per RECIST v1.1
Up to 60 months
Duration of Response
Time Frame: Up to 60 months
To evaluate efficacy parameters such as Duration of Response (DOR) rate per RECIST v1.1
Up to 60 months
Disease Control Rate
Time Frame: Up to 60 months
To evaluate efficacy parameters such as Disease Control Rate (DCR) per RECIST v1.1
Up to 60 months
Progression-Free Survival
Time Frame: Up to 60 months
To evaluate efficacy parameters such as Progression-Free Survival (PFS) per RECIST v1.1
Up to 60 months
Overall Survival
Time Frame: Up to 60 months
To evaluate efficacy parameters such as Overall Survival (OS)
Up to 60 months
Adverse Events
Time Frame: Up to 60 months
To characterize the safety profile of LN-145 in patients with non-small-cell lung cancer (NSCLC)
Up to 60 months
Core Biopsies
Time Frame: Up to 60 months
To determine the feasibility of generating LN-145 using tumor tissue obtained via image-guided core biopsy
Up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iovance Biotherapeutics, Inc.

Investigators

  • Study Director: Iovance Biotherapeutics Study Team, Iovance Biotherapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2021

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

October 21, 2020

First Submitted That Met QC Criteria

October 28, 2020

First Posted (Actual)

November 3, 2020

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOV-LUN-202
  • 2020-003629-45 (EudraCT Number)
  • 2024-510778-26-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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