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

Recruiting now · Phase 2

Conditions studied: Metastatic Non Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT04614103

Run by

Iovance Biotherapeutics, Inc.

People needed

170

Starts

2021-05-07

Expected to finish

2031-12-01

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 may not qualify 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

Where it is running

• Hollywood Private Hospital Ramsay — Nedlands, Western Australia, Australia (enrolling)
• H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States (enrolling)
• Seattle Cancer Care Alliance — Seattle, Washington, United States (enrolling)
• Westmead Hospital — Westmead, New South Wales, Australia (enrolling)
• Advocate Aurora Health — Park Ridge, Illinois, United States (enrolling)
• University of Louisville — Louisville, Kentucky, United States (enrolling)
• VCU Medical Center (Virginia Commonwealth University) — Richmond, Virginia, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• St. Vincent's Hospital — Darlinghurst, New South Wales, Australia (enrolling)
• MD Anderson Cooper — Camden, New Jersey, United States (enrolling)
• New York University Langone Medical Center — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
• Banner Health MD Anderson — Gilbert, Arizona, United States (enrolling)
• Sanford Roger Maris Cancer Center — Fargo, North Dakota, United States (enrolling)
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• Allegheny General Hospital — Natrona Heights, Pennsylvania, United States (enrolling)
• Sanford Cancer Center — Sioux Falls, South Dakota, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• University of Tennessee Medical Center — Knoxville, Tennessee, United States (enrolling)
• Baptist Cancer Center — Memphis, Tennessee, United States (enrolling)
• Centre Hospitalier de l'Universite de Montreal (CHUM) — Montreal, Canada (enrolling)

Full record on ClinicalTrials.gov

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