Study of LN-145 (Tumor Infiltrating Lymphocytes) in patients with metastatic non-small-cell lung cancer

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What is this study about?

This clinical trial is investigating a treatment for patients with metastatic non-small-cell lung cancer. The main treatment being studied is called LN-145, which consists of special immune cells called tumor-infiltrating lymphocytes that are taken from the patient’s own tumor tissue. These cells are processed in a laboratory and then given back to the patient through an intravenous infusion.

Before receiving LN-145, patients will undergo treatment with other medications to prepare their body. These medications include fludarabine, cyclophosphamide, and aldesleukin. The fludarabine is given for 5 days, followed by cyclophosphamide for 2 days, and then the LN-145 cells are infused. After the cell infusion, patients receive aldesleukin to help support the transferred cells.

The purpose of this study is to determine if LN-145 therapy is effective in treating metastatic non-small-cell lung cancer by measuring how many patients respond to the treatment. The study will also evaluate how safe the treatment is and how long the treatment effects last. Patients will be monitored for side effects and their response to therapy throughout the study period.

1 Initial tumor collection

A surgical procedure will be performed to collect tumor tissue for LN-145 preparation

The tumor tissue must be at least 1.5 cm in diameter

For some patients, tissue collection may be done through image-guided core biopsy instead of surgery

2 Treatment preparation period

Laboratory processing of collected tumor tissue to create personalized LN-145 treatment

During this time, you must have recovered from any previous cancer treatments

All previous treatment side effects must improve to mild level or resolve completely

3 Pre-treatment medications

You will receive preparatory medications through intravenous (IV) infusion:

Fludarabine – administered by IV infusion

Cyclophosphamide – administered by IV infusion

These medications prepare your body for the cell therapy treatment

4 Cell therapy administration

The prepared LN-145 cells will be given through IV infusion

After the cell infusion, you will receive aldesleukin (also known as IL-2) through IV administration

5 Monitoring period

Regular medical evaluations will track your response to treatment

Imaging scans will be performed to measure tumor response

Side effects will be monitored and recorded

The monitoring period continues until disease progression or start of new cancer therapy

Who Can Join the Study?

  • You must be between 18 and 70 years old (patients over 70 may be considered after medical review)
  • You must have confirmed metastatic Stage IV non-small cell lung cancer without specific genetic changes (EGFR, ALK, or ROS1)
  • You must have previously received treatment with immunotherapy and platinum-based chemotherapy
  • You must be able to perform daily activities independently and have a life expectancy of more than 6 months
  • You must have at least one tumor that can be surgically removed, measuring at least 1.5 cm
  • You must have at least one measurable tumor remaining after the surgical removal
  • Your blood test results must show:
    – Adequate white blood cell count (neutrophils ≥1000/mm3)
    – Adequate hemoglobin level (≥8.0 g/dL)
    – Adequate platelet count (≥100,000/mm3)
  • Your liver and kidney function tests must be within acceptable ranges
  • Your heart function must be normal (ejection fraction >45%)
  • You must be able to walk for 6 minutes without breathing difficulties
  • You must have recovered from side effects of previous cancer treatments
  • If you can have children or have a partner who can have children, you must use effective birth control during treatment and for 12 months after
  • You must provide written informed consent to participate in the study

Who Cannot Join the Study?

  • Active or untreated brain metastases (cancer that has spread to the brain). Patients with previously treated and stable brain metastases may be eligible
  • Presence of an active autoimmune disease requiring systemic treatment (conditions where the immune system attacks healthy cells)
  • History of severe allergic reactions to biological treatments
  • Uncontrolled high blood pressure or heart disease
  • Active, uncontrolled infections, including hepatitis B, hepatitis C, or HIV
  • Other active cancers requiring treatment (except for adequately treated non-melanoma skin cancer or carcinoma in situ)
  • Major surgery within 4 weeks before starting the study treatment
  • Pregnant or breastfeeding women
  • Previous organ transplant recipients who require ongoing immunosuppression (medications that suppress the immune system)
  • Serious medical conditions that could interfere with study participation or interpretation of results
  • Current participation in other clinical trials or use of investigational drugs within 4 weeks before starting this study
  • Unable to provide informed consent or comply with study procedures

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Azienda Ospedaliero Universitaria Careggi Florence Italy
Technische Universitaet Dresden Dresden Germany
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Universitario De Salamanca Salamanca Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Azienda Sanitaria Territoriale Di Pesaro E Urbino Pesaro Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Centre hospitalier universitaire de Liege Liege Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Consorcio Hospital General Universitario De Valencia Castello De La Plana Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Netherlands Cancer Institute Amsterdam The Netherlands
Centre Hospitalier Lyon Sud Pierre Benite France
Vrije Universiteit Brussel Jette Belgium
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Uuhwmezzrw Mrnfkdr Cnmjhy Hgcqmqadbvfswjtjo Hamburg Germany
Iokbdxibr Oqpczzsast Dua Rkuora Sqav Barcelona Spain
Csma Dj Nbuas Vandoeuvre Les Nancy France
Gyhhrt Uboarwoxqt Fseniurar Frankfurt Germany
Kescvfva ddi Uvjdbfxgbcrh Mypblrsd Afk Munich Germany
Unllxwdvyv Og Acbycok Edegem Belgium
Fyfzzniqf Pauv Lh Iyzonqigdbdci Bhpvmfebx Dqi Hfhjjjiw Ulrrfxrppzbfr Lg Pvc Madrid Spain
Ilepyqcl Pipvdbmofxenxus Cylscp Cwlapo Marseille France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
31.03.2022
France France
Recruiting
31.03.2022
Germany Germany
Not recruiting
31.03.2022
Italy Italy
Not recruiting
31.03.2022
Spain Spain
Not recruiting
31.03.2022
The Netherlands The Netherlands
Not recruiting
31.03.2022

Trial locations

LN-145 (Tumor Infiltrating Lymphocytes) is a personalized cell therapy made from a patient’s own immune cells. These cells, called tumor-infiltrating lymphocytes, are extracted from the patient’s tumor tissue, grown and multiplied in a laboratory, and then given back to the patient. This therapy is designed to help the immune system recognize and fight cancer cells in patients with metastatic non-small-cell lung cancer.

Non-Small-Cell Lung Cancer (Metastatic) – A type of lung cancer that begins in the epithelial cells and has spread from the primary tumor to other parts of the body. It develops when cells in the lungs begin to grow uncontrollably and form tumors that can spread to lymph nodes and distant organs. This cancer typically starts in the cells that line the airways of the lungs. The disease usually progresses gradually, affecting lung function and potentially spreading to other organs such as the brain, bones, or liver. Non-small-cell lung cancer accounts for the majority of all lung cancer cases.

Trial ID:
2024-510778-26-00
Protocol code:
IOV-LUN-202
NCT ID:
NCT04614103
Trial Phase:
Therapeutic exploratory (Phase II)

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