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Using autologous LN-145 cell therapy for metastatic non-small-cell lung cancer

A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (TIL or LN-145) in Patients With Metastatic Non-Small-Cell Lung Cancer

Phase 2 Interventional Iovance Biotherapeutics, Inc. · NCT04614103

This study is testing a new treatment using patients' own immune cells to see if it can help people with advanced non-small-cell lung cancer feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment170 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorIovance Biotherapeutics, Inc. Industry-sponsored
Drugs / interventionsbevacizumab, chemotherapy, prednisone
Locations91 sites (Gilbert, Arizona and 90 other locations)
Trial IDNCT04614103 on ClinicalTrials.gov

What this trial studies

This phase 2 clinical trial evaluates the effectiveness of LN-145, a type of autologous tumor-infiltrating lymphocyte (TIL) therapy, in patients with metastatic non-small-cell lung cancer (NSCLC). The study involves a non-myeloablative lymphodepleting preparative regimen followed by the infusion of the patient's own TILs and administration of interleukin-2 (IL-2). It is a prospective, open-label, multi-cohort, non-randomized study conducted across multiple centers to assess the safety and efficacy of this innovative treatment approach.

Who should consider this trial

Good fit: Ideal candidates include patients with metastatic Stage IV NSCLC who have not had specific genomic alterations and have shown disease progression after first-line therapy.

Not a fit: Patients with EGFR, ALK, or ROS1 genomic alterations may not benefit from this study as they are excluded from participation.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced non-small-cell lung cancer, potentially improving survival rates.

How similar studies have performed: Other studies utilizing TIL therapy have shown promise in treating various cancers, indicating a potential for success with this approach in NSCLC.

Eligibility criteria

Show full inclusion / exclusion 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 this trial is running

Gilbert, Arizona and 90 other locations

+41 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Non Small Cell Lung CancerLN-145Cell TherapyAutologous Adoptive Cell TherapyCellular Immuno-therapyTumor Infiltrating LymphocytesTILIL-2
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.