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Clinical Trials in the UK / NCT04614103
Recruiting Phase 2

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

NCT04614103 · tracked via the Priya Life Science UK tracker
Sponsor
Iovance Biotherapeutics, Inc.
Phase
Phase 2
Started
2021-05-07
Last updated
2026-06-26

Condition(s) studied

Metastatic Non Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

LN-145LN-145

LN-145: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, patient is infused with autologous TIL (LN-145), followed by IL-2.

LN-145: A tumor sample is obtained by image-guided core biopsy from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, patient is infused with autologous TIL (LN-145) followed by IL-2.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (71)

FacilityCityRegionStatus
Banner Health MD Anderson Gilbert Arizona Recruiting
Sylvester Comprehensive Cancer Center Miami Florida Active Not Recruiting
H Lee Moffitt Cancer Center and Research Institute Tampa Florida Recruiting
Rush University Medical Center Chicago Illinois Active Not Recruiting
University of Illinois Hospital & Health Sciences System Chicago Illinois Active Not Recruiting
Advocate Aurora Health Park Ridge Illinois Recruiting
University of Louisville Louisville Kentucky Recruiting
University of Maryland Baltimore Maryland Active Not Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
University of Minnesota Minneapolis Minnesota Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
MD Anderson Cooper Camden New Jersey Recruiting
New York University Langone Medical Center New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
University of North Carolina Chapel Hill North Carolina Recruiting
Novant Health - Winston-Salem Winston-Salem North Carolina Active Not Recruiting
Sanford Roger Maris Cancer Center Fargo North Dakota Recruiting
University of Cincinnati Medical Center Cincinnati Ohio Recruiting
Ohio State University Comprehensive Cancer Center Columbus Ohio Recruiting
Oregon Health and Science University Portland Oregon Recruiting
Allegheny General Hospital Natrona Heights Pennsylvania Recruiting
Sanford Cancer Center Sioux Falls South Dakota Recruiting
Avera Medical Group Cancer Institute Sioux Falls South Dakota Active Not Recruiting
University of Tennessee Medical Center Knoxville Tennessee Recruiting
Baptist Cancer Center Memphis Tennessee Recruiting
VCU Medical Center (Virginia Commonwealth University) Richmond Virginia Recruiting
Seattle Cancer Care Alliance Seattle Washington Recruiting
St. Vincent's Hospital Darlinghurst New South Wales Recruiting
Westmead Hospital Westmead New South Wales Recruiting
Hollywood Private Hospital Ramsay Nedlands Western Australia Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM) Montreal Canada Recruiting
Institut Paoli Calmettes Marseille France Recruiting
CHU Nantes Nantes France Recruiting
CHU Nice Nice France Recruiting
Centre Hospitalier Lyon Sud Pierre-Bénite France Recruiting
CHRU de Poitiers La Miletrie Poitiers France Recruiting
Gustave Roussy Cancer Campus Villejuif France Recruiting
Charite- Universitätsklinikum Berlin Berlin Germany Recruiting
Universitätsklinikum Carl Gustav Carus, MK I Dresden Germany Recruiting
Universitätsklinikum Frankfurt Frankfurt Germany Recruiting

+ 31 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04614103 on ClinicalTrials.gov ↗ ← All trials in the UK