At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- LN-145 (biological), LN-145 (biological)
- How long the study runs
- Study runs about 127 months (dates as stated)
- About the drug or intervention
- LN-145 — biological: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. · LN-145 — biological: 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.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at LN-145, a treatment made from a patient's own immune cells (called tumour-infiltrating lymphocytes), for people with stage 4 non-small-cell lung cancer that has spread to other parts of the body. The sponsor is Iovance Biotherapeutics, Inc.
Who can take part
- Adults with confirmed stage 4 non-small-cell lung cancer that has spread, without changes in the EGFR, ALK or ROS1 genes
- Cancer has got worse during or after first treatment, which included immunotherapy and platinum chemotherapy (with limits on how many treatments you have had)
- At least one tumour that can be removed by surgery to make the treatment, plus at least one other tumour that can be measured
- Good working of organs, heart (including heart pumping strength above a set level) and lungs
- Able to carry out normal daily activities with little or no restriction
- Willing to use highly effective contraception during treatment and for up to 12 months after
- Patients over 70 may join after discussion with the study doctor
Who may not be able to
- People with EGFR, ALK or ROS1 gene changes
- Brain secondaries that are causing symptoms and have not been treated
- Organ transplant from another person, or cell therapy in the past 20 years
- Primary immune system problems
- Taking steroid tablets of 10 mg prednisone a day or more
- Live or weakened vaccines in the past 28 days
- Another cancer in the past 3 years
- Taking part in another treatment study in the past 21 days
What taking part involves
- • Surgery to remove a piece of tumour, which is used to make the LN-145 treatment from your own immune cells
- • The made cells are then given back to you as treatment (this is called TIL therapy)
- • For some patients, cells can be made early, before the cancer gets worse, and given later after the cancer progresses
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 70 Years
- Who
- All
- Number of participants
- 170
- Started
- 2021-05-07
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for metastatic non small cell lung cancer
- • Phase2 - 170 participants
- • 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?
- • Ages 18 Years to 70 Years
- • Diagnosed with metastatic non small cell lung cancer
Where?
- • Chelsea - Royal Marsden Hospital
- • London - Sarah Cannon Research Institute
- • London - University College London
- • Manchester - The Christie NHS Foundation Trust
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
More detail
LN-145 is a ready-to-infuse TIL therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI and further optimized by Iovance for the treatment of patients with metastatic NSCLC. The cell transfer therapy used in this study involves patients receiving a non-myeloablative (NMA) lymphodepleting preparative regimen, followed by infusion of autologous TIL, then finally followed by the administration of IL-2.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 70 Years
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ is allowed if ICI
What the study is looking for
- ✓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 that has spread Stage IV NSCLC without EGFR, ALK, or ROS1...
- ✓At least 1 resectable lesion for TIL production and at least one remaining measurable lesion, as defined by (standard scan measurements)
- ✓Have healthy organ
- ✓LVEF \> 45%, NYHA Class 1
Who cannot take part
- ✗Patients who have EGFR, ALK or ROS1 driver mutations
- ✗Patients who have causing symptoms, 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.
See the full criteria
Where Is This Study? (6 UK sites)
Royal Marsden Hospital
Chelsea SW36JJ, United Kingdom
Sarah Cannon Research Institute
London W1G 6AD, United Kingdom
University College London
London WC1E 68T, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825The Christie NHS Foundation Trust
Manchester M10 4BX, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham B15 2GW, United Kingdom
Guy's Hospital
London SE1 9RT, United Kingdom
How to Get in Touch
Iovance Biotherapeutics Study Team lungcelltherapy.com
Sponsor contactCONTACT
