Tests LN-145 cell therapy for metastatic non-small-cell lung cancer
Tests LN-145, a patient's own immune cells, in adults with advanced lung cancer.
Plain-language title generated from the registry record
Registry title: Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer
Key facts
- Where
- Darlinghurst, Nedlands, and Westmead, AustraliaSee the 3 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with metastatic stage IV non-small-cell lung cancer whose cancer grew after earlier treatment. They need tumour tissue that can be removed to make LN-145 cells.
- Age
- 18 to 70 years. People over 70 may be allowed after discussion with the Medical Monitor.
- Sex
- All sexes can join.
- Disease stage
- Metastatic stage IV non-small-cell lung cancer (NSCLC) without EGFR, ALK or ROS1 changes. At least 1 lesion that can be removed by surgery and at least 1 other measurable lesion. ECOG performance status 0 or 1.
- Earlier treatment
- The cancer must have grown on or after first-line treatment with immunotherapy (ICI) and platinum-based chemotherapy. Up to 1 or 2 earlier lines are allowed, depending on how these were given. People with other targetable gene changes need 1 more line of approved targeted therapy.
- Biomarker or test result
- No EGFR, ALK or ROS1 gene changes.
Main reasons for not taking part
- EGFR, ALK or ROS1 driver mutations
- Symptomatic brain metastases that have not been treated
- Organ transplant or earlier cell therapy in the past 20 years
- Any primary immunodeficiency
- Steroids of 10 mg/day prednisone or more
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT04614103, who can take part
Where in Australia
- St Vincent's HospitalDarlinghurst, AustraliaContact: Iovance Biotherapeutics Study Team lungcelltherapy.comTaking people
- Hollywood Private Hospital RamsayNedlands, AustraliaContact: Iovance Biotherapeutics Study Team lungcelltherapy.comTaking people
- Westmead HospitalWestmead, AustraliaContact: Iovance Biotherapeutics Study Team lungcelltherapy.comTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Iovance Biotherapeutics, Inc.
- Trial code
- NCT04614103EU 2024-510778-26-00
- Record updated
- 26 June 2026
- Original description
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 cancerRead full original descriptionShow less
A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (TIL or LN-145) in Patients With Metastatic Non-Small-Cell Lung Cancer
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
Inclusion: 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: Patients who have had allogeneic organ transplant or prior cell therapy within the past 20 years; 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; Patients who have EGFR, ALK or ROS1 driver mutations; Patients who have symptomatic, untreated brain metastases; Patients who have any form of primary immunodeficiency; Participation in another interventional clinical study within 21 days.