Lung Cancer Clinical Trial

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

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

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Full 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.

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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 is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

170

Study ID:

NCT04614103

Recruitment Status:

Recruiting

Sponsor:

Iovance Biotherapeutics, Inc.

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There are 43 Locations for this study

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City of Hope
Duarte California, 91010, United States
UC San Diego Moores Cancer Center
La Jolla California, 92037, United States
University of Southern California
Los Angeles California, 90033, United States
Christiana Care Health System
Newark Delaware, 19713, United States
University of Florida Health Cancer Center
Gainesville Florida, 32610, United States
Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
AdventHealth Cancer Institute
Orlando Florida, 32804, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Augusta University
Augusta Georgia, 30912, 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
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
MD Anderson Cooper
Camden New Jersey, 08103, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
University of North Carolina
Chapel Hill North Carolina, 27514, United States
Novant Health - Charlotte
Charlotte North Carolina, 28204, United States
Novant Health - Winston-Salem
Winston-Salem North Carolina, 27103, United States
Atrium Health Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
University of Cincinnati Medical Center
Cincinnati Ohio, 45219, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
University of Oklahoma
Oklahoma City Oklahoma, 73104, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Allegheny General Hospital
Natrona Heights Pennsylvania, 15065, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, 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
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
VCU Medical Center (Virginia Commonwealth University)
Richmond Virginia, 23298, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montréal , QC H2, Canada
Universitätsklinikum Carl Gustav Carus, MK I
Dresden , 01307, Germany
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam , 1066, Netherlands
University Hospital of Zurich/ Universitätsspital Zürich
Zürich , 8091, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

170

Study ID:

NCT04614103

Recruitment Status:

Recruiting

Sponsor:


Iovance Biotherapeutics, Inc.

How clear is this clinincal trial information?

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