RecruitingRecruiting
Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer
NCT04614103 · Iovance Biotherapeutics, Inc.
In plain English
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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
About this study
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
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 design
Enrollment target: 170 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-05-07
Estimated completion: 2031-12
Last updated: 2026-06-26
Interventions
Biological: LN-145Biological: LN-145
Primary outcomes
- • Objective Response Rate (Up to 60 months)
Sponsor
Iovance Biotherapeutics, Inc. · industry
Contacts & investigators
ContactIovance Biotherapeutics Study Team lungcelltherapy.com · contact · Clinical.Inquiries@iovance.com · 1-844-845-4682
InvestigatorIovance Biotherapeutics Study Team · study_director, Iovance Biotherapeutics
All locations (71)
Banner Health MD AndersonRecruiting
Gilbert, Arizona, United States
Sylvester Comprehensive Cancer CenterActive Not Recruiting
Miami, Florida, United States
H Lee Moffitt Cancer Center and Research InstituteRecruiting
Tampa, Florida, United States
Rush University Medical CenterActive Not Recruiting
Chicago, Illinois, United States
University of Illinois Hospital & Health Sciences SystemActive Not Recruiting
Chicago, Illinois, United States
Advocate Aurora HealthRecruiting
Park Ridge, Illinois, United States
University of LouisvilleRecruiting
Louisville, Kentucky, United States
University of MarylandActive Not Recruiting
Baltimore, Maryland, United States
Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
MD Anderson CooperRecruiting
Camden, New Jersey, United States
New York University Langone Medical CenterRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
University of North CarolinaRecruiting
Chapel Hill, North Carolina, United States
Novant Health - Winston-SalemActive Not Recruiting
Winston-Salem, North Carolina, United States
Sanford Roger Maris Cancer CenterRecruiting
Fargo, North Dakota, United States
University of Cincinnati Medical CenterRecruiting
Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer CenterRecruiting
Columbus, Ohio, United States
Oregon Health and Science UniversityRecruiting
Portland, Oregon, United States
Allegheny General HospitalRecruiting
Natrona Heights, Pennsylvania, United States
Sanford Cancer CenterRecruiting
Sioux Falls, South Dakota, United States
Avera Medical Group Cancer InstituteActive Not Recruiting
Sioux Falls, South Dakota, United States
University of Tennessee Medical CenterRecruiting
Knoxville, Tennessee, United States
Baptist Cancer CenterRecruiting
Memphis, Tennessee, United States
VCU Medical Center (Virginia Commonwealth University)Recruiting
Richmond, Virginia, United States
Seattle Cancer Care AllianceRecruiting
Seattle, Washington, United States
St. Vincent's HospitalRecruiting
Darlinghurst, New South Wales, Australia
Westmead HospitalRecruiting
Westmead, New South Wales, Australia
Hollywood Private Hospital RamsayRecruiting
Nedlands, Western Australia, Australia
Centre Hospitalier de l'Universite de Montreal (CHUM)Recruiting
Montreal, Canada
Institut Paoli CalmettesRecruiting
Marseille, France
CHU NantesRecruiting
Nantes, France
CHU NiceRecruiting
Nice, France
Centre Hospitalier Lyon SudRecruiting
Pierre-Bénite, France
CHRU de Poitiers La MiletrieRecruiting
Poitiers, France
Gustave Roussy Cancer CampusRecruiting
Villejuif, France
Charite- Universitätsklinikum BerlinRecruiting
Berlin, Germany
Universitätsklinikum Carl Gustav Carus, MK IRecruiting
Dresden, Germany
Universitätsklinikum FrankfurtRecruiting
Frankfurt, Germany
Universitätsklinikum MannheimRecruiting
Mannheim, Germany
Azienda Ospedaliera Universitaria CareggiRecruiting
Florence, Italy
Fondazione IRCCS Policlinico San Matteo di PaviaRecruiting
Pavia, Italy
Azienda Ospedaliera Ospedali Riuniti Marche NordRecruiting
Pesaro, Italy
IRCCS Fondazione del Piemonte per l'OncologiaRecruiting
Piemonte, Italy
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek ZiekenhuisRecruiting
Amsterdam, Netherlands
National Cancer Centre SingaporeRecruiting
Singapore, Singapore
Samsung Medical CenterRecruiting
Seoul, Gangnam-gu, South Korea
Gachon Unversity Gil Medical CenterRecruiting
Incheon, South Korea
Severance Hospital, Yonsei UniversityRecruiting
Seoul, South Korea
Hospital Universitario A CoruñaRecruiting
A Coruña, Spain
Instituto Oncologico RosellRecruiting
Barcelona, Spain
Hospital Clinic de BarcelonaRecruiting
Barcelona, Spain
C.H. Regional Reina SofiaRecruiting
Córdoba, Spain
Hospital Universitario Ramon y CajalRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara CampalRecruiting
Madrid, Spain
Hospital Regional Universitario de MalagaRecruiting
Málaga, Spain
Clinical Universitaria de NavarraRecruiting
Pamplona, Spain
Hospital Universitario de SalamancaRecruiting
Salamanca, Spain
Hospital Universitario Virgen del RocioRecruiting
Seville, Spain
Hospital Clinico Universitario de ValenciaRecruiting
Valencia, Spain
Consorcio Hospital General Universitario de ValenciaRecruiting
Valencia, Spain
Centre Hospitalier Universitaire Vaudois LausanneRecruiting
Lausanne, Canton of Vaud, Switzerland
Royal Marsden HospitalRecruiting
Chelsea, England, United Kingdom
Sarah Cannon Research InstituteRecruiting
London, England, United Kingdom
University College LondonRecruiting
London, England, United Kingdom
The Christie NHS Foundation TrustRecruiting
Manchester, England, United Kingdom
Queen Elizabeth Hospital BirminghamRecruiting
Birmingham, United Kingdom
Guy's HospitalRecruiting
London, United Kingdom