Lung Cancer Clinical Trial

Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

Summary

A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with checkpoint inhibitors or TIL LN-144 (Lifileucel)/LN-145/LN-145-S1 as a single agent therapy.

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Full Description

LN-144 (Lifileucel)/LN-145/LN-145-S1 is an adoptive cell transfer therapy that utilizes an autologous TIL for the treatment of patients with unresectable or metastatic melanoma, advanced, recurrent, or metastatic squamous cell carcinoma of the head and neck, and locally advanced or metastatic non-small cell lung cancer. The adoptive cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphodepletion regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2. Patients in Cohorts 1A, 2A, 3A and 3C will receive TIL plus checkpoint inhibitors. Patients in Cohorts 1B, 1C, and 3B will receive autologous TIL as a single therapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria

Must have a confirmed diagnosis of malignancy of their receptive histologies: unresectable or metastatic melanoma Stage IIIC to IV (Cohorts 1A,1B and 1C), advanced, recurrent or metastatic HNSCC (Cohort 2A), or Stage III or Stage IV non-small cell lung cancer (Cohorts 3A, 3B, and 3C).
Cohorts 1A, 2A, and 3A: If previously treated, patients must have progressed on or after most recent therapy and must not have received CPIs as part of one of the counted lines of prior therapy. Patients must have radiologically documented disease progression while receiving or after the completion of the most recent prior treatment. Patients may have received up to 3 prior systemic anticancer therapies (except for Cohort 3A, where patients whose tumors harbor actionable mutations may have received up to 4 prior systemic therapies)
Cohorts 1B, 1C, 3B, and 3C: Unresectable or metastatic melanoma patients in Cohorts 1B or 1C must have previously received systemic therapy with a PD-1 blocking antibody. NSCLC patients in Cohort 3B must have previously received systemic therapy with any CPI (except for those patients with known oncogene driver mutations that are sensitive to targeted therapies) as part of 1 - 3 prior lines of therapy. NSCLC patients in Cohort 3C must have previously received 1 line of CPI monotherapy. No other systemic therapy for metastatic disease is allowed. Prior chemoradiation and/or chemotherapy in the adjuvant and/or neoadjuvant settings are allowed.
Must have at least 1 resectable lesion
Must have remaining measurable disease as defined by RECIST 1.1 following tumor resection
Must be ≥ 18 years at the time of consent for Cohorts 1A, 1C, 2A, 3A, 3B, and 3C. Patients must be ≥ 12 years at the time of consent for Cohort 1B. Enrollment of patients > 70 years of age may be allowed after consultation with the Medical Monitor.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and an estimated life expectancy of ≥ 6 months.
Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of birth control during treatment and for 12 months after their last dose of IL-2, 4 months after their last dose of pembrolizumab, or 5 months after their last dose of ipilimumab or nivolumab, whichever occurs later.

Exclusion Criteria

Patients with melanoma of uveal/ocular origin.
Patients who have a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years. Patients being retreated with TIL, as part of this study are not excluded.
Patients who have symptomatic, untreated brain metastases
Patients who are on systemic steroid therapy > 10 mg/day of prednisone or other steroid equivalent. Patients receiving steroids as replacement therapy for adrenocortical insufficiency at ≤ 10 mg/day of prednisone or other steroid equivalent may be eligible.
Patients who are pregnant or breastfeeding.
Patients who have an active medical illness(es), which in the opinion of the Investigator, would pose increased risks for study participation
Cohort 1A, 2A, 3A, and 3C patients may not have a medical history of autoimmune disorders (including pneumonitis) requiring treatment or active management.
Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment
Patients who have any form of primary immunodeficiency
Patients with a history of hypersensitivity to any component of the study drugs
Patients who have a left ventricular ejection fraction (LVEF) < 45% or who are New York Heart Association Class II or higher
Patients with respiratory dysfunction or history of smoking are excluded if not meeting either of forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) > 0.7 or FEV1 > 50%.
Patients who have had another primary malignancy within the previous 3 years
Participation in another interventional clinical study within 21 days prior to the initiation of treatment.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

178

Study ID:

NCT03645928

Recruitment Status:

Recruiting

Sponsor:

Iovance Biotherapeutics, Inc.

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There are 45 Locations for this study

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University of California, San Diego
La Jolla California, 92093, United States
University of Southern California
Los Angeles California, 90007, United States
University of California, Los Angeles
Los Angeles California, 90095, United States
University of Colorado
Denver Colorado, 80045, United States
Yale University
New Haven Connecticut, 06520, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
University of Florida
Orlando Florida, 32806, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
University of Louisville
Louisville Kentucky, 40292, United States
University of Maryland
Baltimore Maryland, 21201, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
MD Anderson at Cooper
Camden New Jersey, 08103, United States
Morristown Medical Center
Morristown New Jersey, 07960, United States
Columbia University
New York New York, 10027, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University of Cincinnati
Cincinnati Ohio, 45219, United States
Ohio State University
Columbus Ohio, 43201, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Huntsman Cancer Hospital
Salt Lake City Utah, 84112, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Centre Léon Berard
Lyon , 69008, France
Klinikum rechts der Isar der Technischen Universität München
München Bavaria, 81675, Germany
Universitätsklinikum Carl Gustav Carus
Dresden Sachsen, 01307, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck Schleswig-Holstein, 23538, Germany
Laiko General Hospital of Athens
Athens Attiki, 11527, Greece
Attikon University General Hospital
Athens Attiki, 12461, Greece
Hospital Universitario Marques de Valdecilla
Santander Cantabria, 39008, Spain
University Hospital Vall d'Hebron
Barcelona , 08035, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona , 08908, Spain
Hospital General Universitario Gregorio Marañón
Madrid , 28007, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain
Hospital Regional Universitario de Malaga - Hospital General
Málaga , 29016, Spain
Universitätsspital Basel
Basel , 4031, Switzerland
Universitaetsspital Bern
Bern , 3010, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne , 1011, Switzerland
Guy's Hospital
London England, SE19R, United Kingdom
The Royal Marsden NHS Foundation Trust
London England, SW3 6, United Kingdom
Bristol Haematology and Oncology Centre
Bristol , BS2 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

178

Study ID:

NCT03645928

Recruitment Status:

Recruiting

Sponsor:


Iovance Biotherapeutics, Inc.

How clear is this clinincal trial information?

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