RecruitingPhase 2NCT04614103

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

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

Sponsor

Iovance Biotherapeutics, Inc.

Enrollment

170 participants

Start Date

May 7, 2021

Study Type

INTERVENTIONAL

Conditions

Metastatic Non Small Cell Lung Cancer

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing LN-145, a personalized treatment that uses your own immune cells (tumor-infiltrating lymphocytes, or TIL therapy) to fight metastatic non-small cell lung cancer (NSCLC) that has already been treated with standard therapies. **You may be eligible if...** - You have confirmed stage IV (metastatic) NSCLC without EGFR, ALK, or ROS1 mutations - Your cancer has progressed after standard first-line treatment including immunotherapy and platinum chemotherapy - You are healthy enough to undergo the intensive treatment process involved in TIL therapy - You are willing to undergo a tumor biopsy to harvest immune cells **You may NOT be eligible if...** - You have EGFR, ALK, or ROS1 mutations (other targeted therapies are available) - You have had more prior lines of treatment than the protocol allows - You have certain autoimmune conditions or organ function problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(91)

Banner Health MD Anderson

Gilbert, Arizona, United States

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

CHU Nice

Nice, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

CHRU de Poitiers La Miletrie

Poitiers, France

Gustave Roussy Cancer Campus

Villejuif, France

Charite- Universitätsklinikum Berlin

Berlin, Germany

Universitätsklinikum Bonn

Bonn, Germany

Universitätsklinikum Carl Gustav Carus, MK I

Dresden, Germany

Universitätsklinikum Mannheim

Mannheim, Germany

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, 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 de Salamanca

Salamanca, 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

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NCT04614103

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