Recruiting

Phase 2

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

Sponsor:

Iovance Biotherapeutics, Inc.

Code:

NCT04614103

Conditions

Metastatic Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

LN-145

Study Details

Brief summary:

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

Conditions

Metastatic Non Small Cell Lung Cancer

Study ID

NCT04614103

Start date

May 7, 2021

Status verified date

Jun, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

170 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

Patients whose tumors did not express programmed cell death-ligand 1 (PD-L1), i.e., tumor proportion score (TPS) < 1% prior to ICI treatment and Patients with no available historical TPS for PD-L1 expression

experimental: Cohort 2

Patients whose tumors expressed PD-L1 TPS ≥1% prior to ICI treatment

experimental: Cohort 3

Patients, regardless of tumor PD-L1 TPS prior to ICI treatment, who are unable to safely undergo a surgical tumor resection for TIL generation

experimental: Cohort 4

Patients, regardless of tumor PD-L1 expression status prior to ICI treatment, who have meet all inclusion/exclusion criteria except the requirement to have documented disease progression may elect to have the tumor harvest procedure and TIL production prior to disease progression on their current anticancer treatment. Documentation of progressive disease and identification of a target lesion for RECIST v1.1 assessment is required at Baseline for these patients.

experimental: Retreatment Cohort

Patients who were previously treated with LN-145 in Cohort 1, 2, 3, or 4.

Interventions

LN-145

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

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.

Primary outcome measure

Objective Response Rate [ Time Frame: Up to 60 months ]

Central Contacts and Locations

Central contacts

Iovance Biotherapeutics Study Team lungcelltherapy.com

1-844-845-4682 Clinical.Inquiries@iovance.com

Locations

Banner Health MD Anderson

Recruiting

Gilbert, Arizona, United States, 85234

H Lee Moffitt Cancer Center and Research Institute

Recruiting

Tampa, Florida, United States, 33612

Advocate Aurora Health

Recruiting

Park Ridge, Illinois, United States, 60068

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

MD Anderson Cooper

Recruiting

Camden, New Jersey, United States, 08103

New York University Langone Medical Center

Recruiting

New York, New York, United States, 10016

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27514

Sanford Roger Maris Cancer Center

Recruiting

Fargo, North Dakota, United States, 58102

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Allegheny General Hospital

Recruiting

Natrona Heights, Pennsylvania, United States, 15065

Sanford Cancer Center

Recruiting

Sioux Falls, South Dakota, United States, 57102

University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

Baptist Cancer Center

Recruiting

Memphis, Tennessee, United States, 38120

VCU Medical Center (Virginia Commonwealth University)

Recruiting

Richmond, Virginia, United States, 23298

Seattle Cancer Care Alliance

Recruiting

Seattle, Washington, United States, 98109

Centre Hospitalier de l'Universite de Montreal (CHUM)

Recruiting

Montreal, Canada, QC H2X 3E4

More Information

Sponsor

Iovance Biotherapeutics, Inc.

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

LN-145
Cell Therapy
Autologous Adoptive Cell Therapy
Cellular Immuno-therapy
Tumor Infiltrating Lymphocytes
TIL
IL-2
Non Small Cell Lung Cancer
NSCLC
Second line Lung Cancer
Bronchial Neoplasms
Carcinoma
Lung Disease
Metastatic Lung Cancer
Metastatic Non Small Cell Lung Cancer
Metastatic NSCLC
Lung Carcinoma
PD-L1
Stage IV Lung Cancer
Stage IV Non-Small Cell Lung Cancer
Stage IV NSCLC
Systemic Therapy
2nd line therapy
Second line therapy
CPI
Immune checkpoint inhibitor (ICI)
NSCLC Recurrent
Recurrent Lung Cancer
Recurrent Lung Carcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Iovance Biotherapeutics, Inc. on 2026-06-26.