- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03419559
Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combo With Durvalumab in Non-Small Cell Lung Cancer
April 11, 2019 updated by: Iovance Biotherapeutics, Inc.
A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
This study is a Phase 2, open-label, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) in combination with Anti-PD-L1 inhibitor durvalumab.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI.
The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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La Jolla, California, United States, 92093
- University of California San Diego, Moores Cancer Center
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Los Angeles, California, United States, 90095
- University of California, Los Angeles, Santa Monica Hematology/Oncology
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Kentucky
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Louisville, Kentucky, United States, 40202
- University of Louisville James Graham Brown Cancer Center
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Michigan
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Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute
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New Jersey
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Morristown, New Jersey, United States, 07960
- Morristown Medical Center Atlantic Hematology Oncology
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- UPMC Cancer Center
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University
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Washington
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Seattle, Washington, United States, 98195-0001
- University of Washington Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Confirmed diagnosis of Stage III or Stage IV NSCLC and progressed after ≤ 3 lines of prior systemic therapy in the locally advanced or metastatic setting
- Have at least 1 lesion resectable for TIL generation
- Measurable disease as defined by RECIST v1.1
- Male or female, ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of ≥ 3 months
- Adequate bone marrow function at screening
- Adequate organ function at screening
- A washout period from prior anticancer therapy(ies) of a minimum duration is required prior to first study treatment
- Recovered from all prior anticancer therapy-related AEs to Grade 1 or less (per CTCAE v4.03) prior to enrollment
- Female patients of childbearing potential and male patients with partners of childbearing potential patient must agree to use contraception while on study and during the timeframes as specified following the last dose of study drug(s) received, or until the first dose of the subsequent anticancer therapy, whichever is longer
- Evidence of postmenopausal status or negative urine or serum pregnancy test for female premenopausal patients
Exclusion Criteria:
- History of other malignancies, except for the following: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 3 years
- Patients who have received prior cell therapy
- Patients who have received prior checkpoint inhibitors: such as anti-PD-1, anti-PD-L1 inhibitors, and durvalumab
- Active or prior documented autoimmune or inflammatory disorders
- History of primary or acquired immunodeficiency syndrome, history of allogeneic organ transplant that requires therapeutic immunosuppression
- Received live or attenuated vaccination within 28 days prior to the start of NMA-LD
- Patients with a history of hypersensitivity to any component of the study drugs
- Mean QT interval ≥ 470 msec
- Patients who have a left ventricular ejection fraction (LVEF) of < 45% or who are New York Heart Association (NYHA) Class 2 or higher
- Serious illnesses or medical conditions, which would pose increased risk for study participation and/or compliance with the protocol
- Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of ≤ 60%
- Active central nervous system metastases and/or leptomeningeal disease
- Female patients who are pregnant or breastfeeding
- Active infection including tuberculosis (TB), hepatitis B, hepatitis C, or HIV
- Current or prior use of immunosuppressive medication within 28 days before the first dose of study treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: LN-145 in combination with durvalumab
After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
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adoptive cell therapy (ACT) with autologous TIL therapy
Other Names:
PD-L1 antagonist monoclonal antibody
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: A maximum of 24 months
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To evaluate efficacy using the objective response rate (ORR)
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A maximum of 24 months
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≥ Grade 3 Treatment-Emergent Adverse Event
Time Frame: A maximum of 24 months
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To evaluate the safety as measured by any ≥ Grade 3 treatment-emergent adverse event (TEAE) rate
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A maximum of 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Response
Time Frame: A maximum of 24 months
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To further evaluate efficacy such as the duration of response (DOR)
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A maximum of 24 months
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Progression Free Survival
Time Frame: A maximum of 24 months
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To further evaluate efficacy such as progression free survival (PFS)
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A maximum of 24 months
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Overall Survival
Time Frame: A minimum of 5 years
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To further evaluate efficacy such as overall survival (OS)
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A minimum of 5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 28, 2018
Primary Completion (ANTICIPATED)
December 1, 2021
Study Completion (ANTICIPATED)
December 1, 2024
Study Registration Dates
First Submitted
January 14, 2018
First Submitted That Met QC Criteria
January 26, 2018
First Posted (ACTUAL)
February 5, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 11, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IOV-LUN-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Stanford UniversityAstraZenecaRecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIUnited States
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National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
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Ohio State University Comprehensive Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
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Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
Clinical Trials on LN-145
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Iovance Biotherapeutics, Inc.CompletedSquamous Cell Carcinoma of the Head and NeckUnited States
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Yale UniversityIovance Biotherapeutics, Inc.CompletedMetastatic Triple Negative Breast CancerUnited States
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Iovance Biotherapeutics, Inc.RecruitingSquamous Cell Carcinoma of the Head and Neck | Metastatic Melanoma | Non-small Cell Lung CancerUnited States, Spain, Canada, France, Germany, Greece, Switzerland, United Kingdom
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI); Iovance Biotherapeutics, Inc.Active, not recruitingMalignant Solid Neoplasm | Soft Tissue Sarcoma | Recurrent Ovarian Carcinoma | Triple Negative Breast Cancer | Recurrent Osteosarcoma | Refractory Osteosarcoma | Bone Sarcoma | Giant Cell Tumor of Bone | Ovarian Carcinosarcoma | Platinum-Resistant Ovarian Carcinoma | Dedifferentiated Chondrosarcoma | Malignancy... and other conditionsUnited States
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Iovance Biotherapeutics, Inc.RecruitingCervical CarcinomaUnited States, Spain, United Kingdom, Germany, France, Italy, Netherlands, Switzerland
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Iovance Biotherapeutics, Inc.RecruitingMetastatic Non Small Cell Lung CancerUnited States, Canada, Germany, Netherlands
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SecuraBioCompleted
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Institut Cancerologie de l'OuestDirection Générale de l'Offre de SoinsTerminatedInvasive Breast Cancer | Sentinel Lymph Node Biopsy | Ipsilateral RecurrenceFrance
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University of FloridaCompletedProstate CancerUnited States
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Memorial Sloan Kettering Cancer CenterIovance Biotherapeutics, Inc.RecruitingMelanoma | Metastatic Melanoma | Metastatic Uveal Melanoma | Uveal MelanomaUnited States