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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

13 criteria

  • 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 trial?

12 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

LN-145 – A personalized cell therapy treatment consisting of autologous tumor infiltrating lymphocytes (TILs) that are harvested from a patient's own tumor tissue, expanded in the laboratory, and then reinfused back into the patient. This investigational therapy is administered through intravenous infusion and is currently being studied in clinical trials for the treatment of metastatic non-small-cell lung cancer (NSCLC). LN-145 belongs to the class of immunotherapy treatments and works by using the patient's own immune cells to recognize and attack cancer cells, potentially enhancing the body's natural ability to fight cancer. The treatment represents a personalized approach to cancer immunotherapy, where each patient receives their own specifically cultured immune cells.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510778-26-00Protocol codeIOV-LUN-202Estimated enrolment225 patientsSponsorIovance Biotherapeutics Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).