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NCT04614103PHASE2Recruiting

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

Iovance Biotherapeutics, Inc.

Start Date

5/7/2021

Completion Date

12/1/2031

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

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.

Eligibility Criteria

Age Range: 18 years to 70 years

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

Interventions

BIOLOGICAL

LN-145

BIOLOGICAL

LN-145

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Conditions

Metastatic Non Small Cell Lung Cancer

Locations

Banner Health MD Anderson

Gilbert, Arizona 85234

United States

Sylvester Comprehensive Cancer Center

Miami, Florida 33136

United States

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida 33612

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

University of Illinois Hospital & Health Sciences System

Chicago, Illinois 60612

United States

Advocate Aurora Health

Park Ridge, Illinois 60068

United States

University of Louisville

Louisville, Kentucky 40202

United States

University of Maryland

Baltimore, Maryland 21201

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

University of Minnesota

Minneapolis, Minnesota 55455

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

MD Anderson Cooper

Camden, New Jersey 08103

United States

New York University Langone Medical Center

New York, New York 10016

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

University of North Carolina

Chapel Hill, North Carolina 27514

United States

Novant Health - Winston-Salem

Winston-Salem, North Carolina 27103

United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota 58102

United States

University of Cincinnati Medical Center

Cincinnati, Ohio 45219

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio 43210

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

Allegheny General Hospital

Natrona Heights, Pennsylvania 15065

United States

Sanford Cancer Center

Sioux Falls, South Dakota 57102

United States

Avera Medical Group Cancer Institute

Sioux Falls, South Dakota 57105

United States

University of Tennessee Medical Center

Knoxville, Tennessee 37920

United States

Baptist Cancer Center

Memphis, Tennessee 38120

United States

VCU Medical Center (Virginia Commonwealth University)

Richmond, Virginia 23298

United States

Seattle Cancer Care Alliance

Seattle, Washington 98109

United States

St. Vincent's Hospital

Darlinghurst, New South Wales 2010

Australia

Westmead Hospital

Westmead, New South Wales 2145

Australia

Hollywood Private Hospital Ramsay

Nedlands, Western Australia 6009

Australia

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, QC H2X 3E4

Canada

Institut Paoli Calmettes

Marseille, 13009

France

CHU Nantes

Nantes, 44093

France

CHU Nice

Nice, 06001

France

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310

France

CHRU de Poitiers La Miletrie

Poitiers, 90577

France

Gustave Roussy Cancer Campus

Villejuif, 94805

France

Charite- Universitätsklinikum Berlin

Berlin, 13353

Germany

Universitätsklinikum Carl Gustav Carus, MK I

Dresden, 01307

Germany

Universitätsklinikum Frankfurt

Frankfurt, 60591

Germany

Universitätsklinikum Mannheim

Mannheim, 68167

Germany

Azienda Ospedaliera Universitaria Careggi

Florence, 50134

Italy

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, 27100

Italy

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, 61122

Italy

IRCCS Fondazione del Piemonte per l'Oncologia

Piemonte, 10060

Italy

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, 1066

Netherlands

National Cancer Centre Singapore

Singapore, 168583

Singapore

Samsung Medical Center

Seoul, Gangnam-gu 6351

South Korea

Gachon Unversity Gil Medical Center

Incheon, 21565

South Korea

Severance Hospital, Yonsei University

Seoul, 3722

South Korea

Hospital Universitario A Coruña

A Coruña, 15006

Spain

Instituto Oncologico Rosell

Barcelona, 08028

Spain

Hospital Clinic de Barcelona

Barcelona, 08036

Spain

C.H. Regional Reina Sofia

Córdoba, 14004

Spain

Hospital Universitario Ramon y Cajal

Madrid, 28034

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal

Madrid, 28050

Spain

Hospital Regional Universitario de Malaga

Málaga, 29016

Spain

Clinical Universitaria de Navarra

Pamplona, 31008

Spain

Hospital Universitario de Salamanca

Salamanca, 90577

Spain

Hospital Universitario Virgen del Rocio

Seville, 41013

Spain

Hospital Clinico Universitario de Valencia

Valencia, 46010

Spain

Consorcio Hospital General Universitario de Valencia

Valencia, 46014

Spain

Centre Hospitalier Universitaire Vaudois Lausanne

Lausanne, Canton of Vaud 1011

Switzerland

Royal Marsden Hospital

Chelsea, England SW36JJ

United Kingdom

Sarah Cannon Research Institute

London, England W1G 6AD

United Kingdom

University College London

London, England WC1E 68T

United Kingdom

The Christie NHS Foundation Trust

Manchester, England M10 4BX

United Kingdom

Queen Elizabeth Hospital Birmingham

Birmingham, B15 2GW

United Kingdom

Guy's Hospital

London, SE1 9RT

United Kingdom