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RECRUITING

NCT04614103

PHASE2

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

Sponsor: Iovance Biotherapeutics, Inc.

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2021-05-07

Completion Date

2031-12

Last Updated

2025-11-12

Healthy Volunteers

Conditions

Metastatic Non Small Cell Lung Cancer

Interventions

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.

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.

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

Locations (84)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (84)