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

NCT04614103 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: IOV-LUN-2022020-003629-452024-510778-26-00
• Study Type: interventional
• Target: 170
• Locations: 12 countries
• Sites: 91

Brief 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

Conditions

Metastatic Non Small Cell Lung Cancer

Keywords

LN-145; Cell Therapy; Autologous Adoptive Cell Therapy; Cellular Immuno-therapy; Tumor Infiltrating Lymphocytes; TIL; IL-2; Non Small Cell Lung Cancer; NSCLC; Second line Lung Cancer; Bronchial Neoplasms; Carcinoma; Lung Disease; Metastatic Lung Cancer; Metastatic Non Small Cell Lung Cancer; Metastatic NSCLC; Lung Carcinoma; PD-L1; Stage IV Lung Cancer; Stage IV Non-Small Cell Lung Cancer; Stage IV NSCLC; Systemic Therapy; 2nd line therapy; Second line therapy; CPI; Immune checkpoint inhibitor (ICI); NSCLC Recurrent; Recurrent Lung Cancer; Recurrent Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 60 months

Secondary Outcomes (8)

• Objective Response Rate

  Up to 60 months

• Complete Response Rate

  Up to 60 months

• Duration of Response

  Up to 60 months

• Disease Control Rate

  Up to 60 months

• Progression-Free Survival

  Up to 60 months

Study Arms (5)

Cohort 1

EXPERIMENTAL

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

Cohort 2

EXPERIMENTAL

Patients whose tumors expressed PD-L1 TPS ≥1% prior to ICI treatment

Biological: LN-145

Cohort 3

EXPERIMENTAL

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

Cohort 4

EXPERIMENTAL

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

Retreatment Cohort

EXPERIMENTAL

Patients who were previously treated with LN-145 in Cohort 1, 2, 3, or 4.

Biological: LN-145

Interventions

LN-145 BIOLOGICAL

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

Cohort 1; Cohort 2; Cohort 4; Retreatment Cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iovance Biotherapeutics, Inc.: lead

Study Sites (91)

Banner Health MD Anderson

Gilbert, Arizona, 85234, United States

RECRUITING

City of Hope

Duarte, California, 91010, United States

WITHDRAWN

UC San Diego Moores Cancer Center

La Jolla, California, 92037, United States

WITHDRAWN

University of Southern California

Los Angeles, California, 90033, United States

WITHDRAWN

Christiana Care Health System

Newark, Delaware, 19713, United States

WITHDRAWN

University of Florida Health Cancer Center

Gainesville, Florida, 32610, United States

WITHDRAWN

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

RECRUITING

AdventHealth Cancer Institute

Orlando, Florida, 32804, United States

WITHDRAWN

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

RECRUITING

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

WITHDRAWN

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, 60612, United States

WITHDRAWN

Advocate Aurora Health

Park Ridge, Illinois, 60068, United States

RECRUITING

University of Kentucky-Markey Cancer Center

Lexington, Kentucky, 40536, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

WITHDRAWN

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

WITHDRAWN

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

MD Anderson Cooper

Camden, New Jersey, 08103, United States

WITHDRAWN

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

WITHDRAWN

New York University Langone Medical Center

New York, New York, 10016, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

WITHDRAWN

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

University of Rochester Medical Center

Rochester, New York, 14642, United States

WITHDRAWN

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Novant Health - Charlotte

Charlotte, North Carolina, 28204, United States

WITHDRAWN

Novant Health - Winston-Salem

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Atrium Health Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

WITHDRAWN

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58102, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

WITHDRAWN

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Allegheny General Hospital

Natrona Heights, Pennsylvania, 15065, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

WITHDRAWN

Sanford Cancer Center

Sioux Falls, South Dakota, 57102, United States

RECRUITING

Avera Medical Group Cancer Institute

Sioux Falls, South Dakota, 57105, United States

WITHDRAWN

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

RECRUITING

Baptist Cancer Center

Memphis, Tennessee, 38120, United States

RECRUITING

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

WITHDRAWN

Houston Methodist

Houston, Texas, 77030, United States

WITHDRAWN

VCU Medical Center (Virginia Commonwealth University)

Richmond, Virginia, 23298, United States

RECRUITING

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

RECRUITING

St. Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Hollywood Private Hospital Ramsay

Nedlands, Western Australia, 6009, Australia

RECRUITING

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, QC H2X 3E4, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, M5G 2C1, Canada

WITHDRAWN

Institut Paoli Calmettes

Marseille, 13009, France

RECRUITING

CHU Nantes

Nantes, 44093, France

RECRUITING

CHU Nice

Nice, 06001, France

RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

RECRUITING

CHRU de Poitiers La Miletrie

Poitiers, 90577, France

RECRUITING

Gustave Roussy Cancer Campus

Villejuif, 94805, France

RECRUITING

Charite- Universitätsklinikum Berlin

Berlin, 13353, Germany

RECRUITING

Universitätsklinikum Bonn

Bonn, 53127, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus, MK I

Dresden, 01307, Germany

RECRUITING

Universitätsklinikum Mannheim

Mannheim, 68167, Germany

RECRUITING

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, 27100, Italy

RECRUITING

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, 61122, Italy

RECRUITING

IRCCS Fondazione del Piemonte per l'Oncologia

Piemonte, 10060, Italy

RECRUITING

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, 1066, Netherlands

RECRUITING

National Cancer Centre Singapore

Singapore, 168583, Singapore

RECRUITING

Samsung Medical Center

Seoul, Gangnam-gu, 6351, South Korea

RECRUITING

Gachon Unversity Gil Medical Center

Incheon, 21565, South Korea

RECRUITING

Severance Hospital, Yonsei University

Seoul, 3722, South Korea

RECRUITING

Hospital Universitario A Coruña

A Coruña, 15006, Spain

RECRUITING

Instituto Oncologico Rosell

Barcelona, 08028, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

C.H. Regional Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal

Madrid, 28050, Spain

RECRUITING

Hospital Regional Universitario de Malaga

Málaga, 29016, Spain

RECRUITING

Clinical Universitaria de Navarra

Pamplona, 31008, Spain

RECRUITING

Hospital Universitario de Salamanca

Salamanca, 90577, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Consorcio Hospital General Universitario de Valencia

Valencia, 46014, Spain

RECRUITING

Centre Hospitalier Universitaire Vaudois Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

University Hospital of Zurich/ Universitätsspital Zürich

Zurich, 8091, Switzerland

WITHDRAWN

Royal Marsden Hospital

Chelsea, England, SW36JJ, United Kingdom

RECRUITING

Sarah Cannon Research Institute

London, England, W1G 6AD, United Kingdom

RECRUITING

University College London

London, England, WC1E 68T, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, England, M10 4BX, United Kingdom

RECRUITING

Guy's Hospital

London, SE1 9RT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Bronchial Neoplasms; Carcinoma; Lung Diseases; Lung Neoplasms

Interventions

Toll-Like Receptor 1

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Bronchial Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Toll-Like Receptors; Receptors, Pattern Recognition; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Iovance Biotherapeutics Study Team

  Iovance Biotherapeutics

  STUDY DIRECTOR

Central Study Contacts

Iovance Biotherapeutics Study Team lungcelltherapy.com

CONTACT

1-844-845-4682; Clinical.Inquiries@iovance.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 3, 2020
• Study Start: May 7, 2021
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

AU (3); ES (14); GB (5); KR (3); CA (2); NL (1); DE (4); FR (6); SG (1); CH (2); US (46); IT (4)