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Looking for participantsPhase2

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

Sponsor: Iovance Biotherapeutics, Inc.

NCT ID: NCT04614103

View on ClinicalTrials.gov ↗

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.

Metastatic Non Small Cell Lung Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

EGFRALKROS1

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
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 Is This Study? (6 UK sites)

Royal Marsden Hospital

Chelsea SW36JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Sarah Cannon Research Institute

London W1G 6AD, United Kingdom

Recruiting

University College London

London WC1E 68T, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

The Christie NHS Foundation Trust

Manchester M10 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Queen Elizabeth Hospital Birmingham

Birmingham B15 2GW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Guy's Hospital

London SE1 9RT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

How to Get in Touch

Iovance Biotherapeutics Study Team lungcelltherapy.com

Sponsor contact

CONTACT

1-844-845-4682 Clinical.Inquiries@iovance.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06