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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to 70 Years
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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

You cannot join if

• 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

autologous tumor infiltrating lymphocytes LN-145. A proprietary preparation of autologous tumor infiltrating lymphocytes (TILs), with potential immunomodulating activity. The autologous TILs are isolated from an autologous tumor sample and expanded ex vivo in the presence of interleukin-2 (IL-2). Upon infusion of the autologous TILs LN-145 back into the patient, the cells specifically recognize, target and kill the patient's tumor cells. NCI Drug Dictionary

Treatments listed in the registry

• LN-145 (Biological): A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, patient is infused with autologous TIL (LN-145), followed by IL-2.
• 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. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, patient is infused with autologous TIL (LN-145) followed by IL-2.

Non Randomized · Parallel · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• biopsy: Part of the study plan
• surgery: Part of the study plan

Main goals

• Objective Response Rate (Up to 60 months)

Other goals

• Objective Response Rate
• Complete Response Rate
• Duration of Response
• Disease Control Rate
• Progression-Free Survival
• Overall Survival
• Adverse Events
• Core Biopsies

Planned enrollment: 170 (estimated).

• Banner Health MD Anderson, Gilbert, Arizona
• H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida
• Advocate Aurora Health, Park Ridge, Illinois
• University of Louisville, Louisville, Kentucky
• Karmanos Cancer Institute, Detroit, Michigan
• University of Minnesota, Minneapolis, Minnesota
• University of Nebraska Medical Center, Omaha, Nebraska
• MD Anderson Cooper, Camden, New Jersey
• New York University Langone Medical Center, New York, New York
• Memorial Sloan Kettering Cancer Center, New York, New York
• University of North Carolina, Chapel Hill, North Carolina
• Sanford Roger Maris Cancer Center, Fargo, North Dakota
• University of Cincinnati Medical Center, Cincinnati, Ohio
• Ohio State University Comprehensive Cancer Center, Columbus, Ohio
• Oregon Health and Science University, Portland, Oregon
• Allegheny General Hospital, Natrona Heights, Pennsylvania
• Sanford Cancer Center, Sioux Falls, South Dakota
• University of Tennessee Medical Center, Knoxville, Tennessee
• Baptist Cancer Center, Memphis, Tennessee
• VCU Medical Center (Virginia Commonwealth University), Richmond, Virginia
• Seattle Cancer Care Alliance, Seattle, Washington

44 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT04614103
• NCI Drug Dictionary: C135634

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jun 25, 2026. Public record; not medical advice.