RECRUITING

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

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Conditions

Metastatic Non Small Cell Lung CancerLN-145Cell TherapyAutologous Adoptive Cell TherapyCellular Immuno-therapyTumor Infiltrating LymphocytesTILIL-2Non Small Cell Lung CancerNSCLCSecond line Lung CancerBronchial NeoplasmsCarcinomaLung DiseaseMetastatic Lung CancerMetastatic NSCLCLung CarcinomaPD-L1Stage IV Lung CancerStage IV Non-Small Cell Lung CancerStage IV NSCLCSystemic Therapy2nd line therapySecond line therapyCPIImmune checkpoint inhibitor (ICI)NSCLC RecurrentRecurrent Lung CancerRecurrent Lung Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2021-05-07
Study Completion:2031-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04614103

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients who are over 70 years of age may be allowed to enroll after discussion with the Medical Monitor.
  2. * Have historically or pathologically confirmed diagnosis of metastatic Stage IV NSCLC without EGFR, ALK, or ROS1 genomic alterations.
  3. * 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.
  4. * 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.
  5. * 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
  6. * 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.
  7. * At least 1 resectable lesion for TIL production and at least one remaining measurable lesion, as defined by RECIST v1.1
  8. * Have adequate organ function
  9. * LVEF \> 45%, NYHA Class 1
  10. * Have adequate pulmonary function
  11. * ECOG performance status of 0 or 1
  12. * 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
  1. * Patients who have EGFR, ALK or ROS1 driver mutations
  2. * Patients who have symptomatic, untreated brain metastases.
  3. * Patients who have had allogeneic organ transplant or prior cell therapy within the past 20 years
  4. * Patients who have any form of primary immunodeficiency
  5. * Patients who are on systemic steroid therapy ≥ 10 mg/day of prednisone or equivalent.
  6. * Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment
  7. * Patients who have had another primary malignancy within the previous 3 years
  8. * Participation in another interventional clinical study within 21 days

Contacts and Locations

Study Contact

Iovance Biotherapeutics Study Team lungcelltherapy.com
CONTACT
1-844-845-4682
Clinical.Inquiries@iovance.com

Principal Investigator

Iovance Biotherapeutics Study Team
STUDY_DIRECTOR
Iovance Biotherapeutics

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Iovance Biotherapeutics, Inc.

  • Iovance Biotherapeutics Study Team, STUDY_DIRECTOR, Iovance Biotherapeutics

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 Registration Dates

Study Start Date2021-05-07
Study Completion Date2031-12

Study Record Updates

Study Start Date2021-05-07
Study Completion Date2031-12

Terms related to this study

Keywords Provided by Researchers

  • LN-145
  • Cell Therapy
  • Autologous Adoptive Cell Therapy
  • Cellular Immuno-therapy
  • Tumor Infiltrating Lymphocytes
  • TIL
  • IL-2
  • Non Small Cell Lung Cancer
  • NSCLC
  • Second line Lung Cancer
  • Bronchial Neoplasms
  • Carcinoma
  • Lung Disease
  • Metastatic Lung Cancer
  • Metastatic Non Small Cell Lung Cancer
  • Metastatic NSCLC
  • Lung Carcinoma
  • PD-L1
  • Stage IV Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Stage IV NSCLC
  • Systemic Therapy
  • 2nd line therapy
  • Second line therapy
  • CPI
  • Immune checkpoint inhibitor (ICI)
  • NSCLC Recurrent
  • Recurrent Lung Cancer
  • Recurrent Lung Carcinoma

Additional Relevant MeSH Terms

  • Metastatic Non Small Cell Lung Cancer