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LN-145 for Metastatic Non-Small Cell Lung Cancer

This study is testing a treatment called LN-145 for people with metastatic non-small cell lung cancer (NSCLC), which is lung cancer that has spread. LN-145 is a type of cell therapy where doctors take a sample of your tumor, grow special immune cells (called tumor infiltrating lymphocytes or TILs) from it in a lab, and then give them back to you. Before receiving LN-145, you will have chemotherapy to prepare your body. The study is looking at how many patients respond to the treatment. You may be able to join if you are between 18 and 70 years old and have metastatic NSCLC without certain genetic changes (EGFR, ALK, or ROS1).

Study design
This is a Phase 2, open-label study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll about 170 participants.
What's involved
You will have a tumor sample taken, either through surgery or a biopsy. You will also receive chemotherapy and then the LN-145 infusion, followed by IL-2.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be measured for up to 60 months (5 years).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04614103

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

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Iovance Biotherapeutics, Inc.
~170 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:LN-145

At a glance

Recruiting sites
65 of 71 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate
Measured over Up to 60 months

Conditions

Metastatic Non Small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

71 sites across 33 states
Spain14
France6
Germany4
Italy4
England4
Illinois3
Florida2
New York2

Study leadership

  • Iovance Biotherapeutics Study Team · STUDY_DIRECTOR · Iovance Biotherapeutics

Who to contact

Iovance Biotherapeutics Study Team lungcelltherapy.com
[email protected]
1-844-845-4682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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 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

What this trial measures

  • Objective Response RateUp to 60 months

    To evaluate the efficacy of LN-145 as determined by objective response rate (ORR) in patients with metastatic NSCLC using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as assessed by central review for Cohorts 1 and 2 and by the investigator for Cohorts 3, 4 and the Retreatment Cohort