Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer
Recruiting · NCT04614103 · Interventional (participants receive a specific treatment) · Lead sponsor: Iovance Biotherapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
LN-145
What this trial is about
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
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 19 US states.
- Banner Health MD Anderson - Gilbert, Arizona, United States
- Sylvester Comprehensive Cancer Center - Miami, Florida, United States
- H Lee Moffitt Cancer Center and Research Institute - Tampa, Florida, United States
- Rush University Medical Center - Chicago, Illinois, United States
- University of Illinois Hospital & Health Sciences System - Chicago, Illinois, United States
- Advocate Aurora Health - Park Ridge, Illinois, United States
- University of Louisville - Louisville, Kentucky, United States
- University of Maryland - Baltimore, Maryland, United States
- Karmanos Cancer Institute - Detroit, Michigan, United States
- University of Minnesota - Minneapolis, Minnesota, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- MD Anderson Cooper - Camden, New Jersey, United States
- New York University Langone Medical Center - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- University of North Carolina - Chapel Hill, North Carolina, United States
- Novant Health - Winston-Salem - Winston-Salem, North Carolina, United States
- Sanford Roger Maris Cancer Center - Fargo, North Dakota, United States
- University of Cincinnati Medical Center - Cincinnati, Ohio, United States
- Ohio State University Comprehensive Cancer Center - Columbus, Ohio, United States
- Oregon Health and Science University - Portland, Oregon, United States
- Allegheny General Hospital - Natrona Heights, Pennsylvania, United States
- Sanford Cancer Center - Sioux Falls, South Dakota, United States
- Avera Medical Group Cancer Institute - Sioux Falls, South Dakota, United States
- University of Tennessee Medical Center - Knoxville, Tennessee, United States
- Baptist Cancer Center - Memphis, Tennessee, United States
- VCU Medical Center (Virginia Commonwealth University) - Richmond, Virginia, United States
- Seattle Cancer Care Alliance - Seattle, Washington, United States
- Hospital Universitario A Coruña - A Coruña, Spain
- Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis - Amsterdam, Netherlands
- Instituto Oncologico Rosell - Barcelona, Spain
- Hospital Clinic de Barcelona - Barcelona, Spain
- Charite- Universitätsklinikum Berlin - Berlin, Germany
- Queen Elizabeth Hospital Birmingham - Birmingham, United Kingdom
- C.H. Regional Reina Sofia - Córdoba, Spain
- Universitätsklinikum Carl Gustav Carus, MK I - Dresden, Germany
- Azienda Ospedaliera Universitaria Careggi - Florence, Italy
- Universitätsklinikum Frankfurt - Frankfurt, Germany
- Gachon Unversity Gil Medical Center - Incheon, South Korea
- Guy's Hospital - London, United Kingdom
- Hospital Universitario Ramon y Cajal - Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Hospital Universitario La Paz - Madrid, Spain
- Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal - Madrid, Spain
- Universitätsklinikum Mannheim - Mannheim, Germany
- Institut Paoli Calmettes - Marseille, France
- Centre Hospitalier de l'Universite de Montreal (CHUM) - Montreal, Canada
- Hospital Regional Universitario de Malaga - Málaga, Spain
- CHU Nantes - Nantes, France
- CHU Nice - Nice, France
- Clinical Universitaria de Navarra - Pamplona, Spain
- Fondazione IRCCS Policlinico San Matteo di Pavia - Pavia, Italy
- Azienda Ospedaliera Ospedali Riuniti Marche Nord - Pesaro, Italy
- IRCCS Fondazione del Piemonte per l'Oncologia - Piemonte, Italy
- Centre Hospitalier Lyon Sud - Pierre-Bénite, France
- CHRU de Poitiers La Miletrie - Poitiers, France
- Hospital Universitario de Salamanca - Salamanca, Spain
- Severance Hospital, Yonsei University - Seoul, South Korea
- Hospital Universitario Virgen del Rocio - Seville, Spain
- National Cancer Centre Singapore - Singapore, Singapore
- Hospital Clinico Universitario de Valencia - Valencia, Spain
Showing 60 of 71 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →