Lung Cancer Clinical Trial
Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors
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.
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.
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.
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.
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There are 45 Locations for this study
La Jolla California, 92093, United States
Los Angeles California, 90007, United States
Los Angeles California, 90095, United States
Denver Colorado, 80045, United States
New Haven Connecticut, 06520, United States
Washington District of Columbia, 20007, United States
Miami Beach Florida, 33140, United States
Orlando Florida, 32610, United States
Tampa Florida, 33612, United States
Louisville Kentucky, 40292, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02114, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Camden New Jersey, 08103, United States
Morristown New Jersey, 07960, United States
New York New York, 10027, United States
New York New York, 10065, United States
Cincinnati Ohio, 45219, United States
Columbus Ohio, 43201, United States
Sioux Falls South Dakota, 57105, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98109, United States
Milwaukee Wisconsin, 53226, United States
Toronto Ontario, M5G 2, Canada
Lyon , 69008, France
München Bavaria, 81675, Germany
Dresden Sachsen, 01307, Germany
Lübeck Schleswig-Holstein, 23538, Germany
Athens Attiki, 11527, Greece
Athens Attiki, 12461, Greece
Santander Cantabria, 39008, Spain
Barcelona , 08035, Spain
Barcelona , 08908, Spain
Madrid , 28007, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Málaga , 29016, Spain
Basel , 4031, Switzerland
Bern , 3010, Switzerland
Lausanne , 1011, Switzerland
London England, SE19R, United Kingdom
London England, SW3 6, United Kingdom
Bristol , BS2 8, United Kingdom
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