Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combo With Durvalumab in Non-Small Cell Lung Cancer

Study summary

This study is a Phase 2, open-label, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) in combination with Anti-PD-L1 inhibitor durvalumab.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLN-145 and Durvalumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 16, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?Iovance Biotherapeutics, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Iovance Biotherapeutics, Inc.
Interventions being studied: Biological: LN-145; Drug: Durvalumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Biomarkers

PD-L1→

Treatment approach

Immunotherapy→Cell or gene therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Confirmed diagnosis of Stage III or Stage IV NSCLC and progressed after ≤ 3 lines of prior systemic therapy in the locally advanced or metastatic setting
Have at least 1 lesion resectable for TIL generation
Measurable disease as defined by RECIST v1.1
Male or female, ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of ≥ 3 months
Adequate bone marrow function at screening
Adequate organ function at screening
A washout period from prior anticancer therapy(ies) of a minimum duration is required prior to first study treatment
Recovered from all prior anticancer therapy-related AEs to Grade 1 or less (per CTCAE v4.03) prior to enrollment
Female patients of childbearing potential and male patients with partners of childbearing potential patient must agree to use contraception while on study and during the timeframes as specified following the last dose of study drug(s) received, or until the first dose of the subsequent anticancer therapy, whichever is longer
Evidence of postmenopausal status or negative urine or serum pregnancy test for female premenopausal patients

Reasons someone may not be able to joinExclusion criteria

History of other malignancies, except for the following: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 3 years
Patients who have received prior cell therapy
Patients who have received prior checkpoint inhibitors: such as anti-PD-1, anti-PD-L1 inhibitors, and durvalumab
Active or prior documented autoimmune or inflammatory disorders
History of primary or acquired immunodeficiency syndrome, history of allogeneic organ transplant that requires therapeutic immunosuppression
Received live or attenuated vaccination within 28 days prior to the start of NMA-LD
Patients with a history of hypersensitivity to any component of the study drugs
Mean QT interval ≥ 470 msec
Patients who have a left ventricular ejection fraction (LVEF) of \< 45% or who are New York Heart Association (NYHA) Class 2 or higher
Serious illnesses or medical conditions, which would pose increased risk for study participation and/or compliance with the protocol
Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of ≤ 60%
Active central nervous system metastases and/or leptomeningeal disease
Female patients who are pregnant or breastfeeding
Active infection including tuberculosis (TB), hepatitis B, hepatitis C, or HIV
Current or prior use of immunosuppressive medication within 28 days before the first dose of study treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of California San Diego, Moores Cancer CenterLa Jolla, California
University of California, Los Angeles, Santa Monica Hematology/OncologyLos Angeles, California
University of Louisville James Graham Brown Cancer CenterLouisville, Kentucky
Karmanos Cancer InstituteDetroit, Michigan
Morristown Medical Center Atlantic Hematology OncologyMorristown, New Jersey
UPMC Cancer CenterPittsburgh, Pennsylvania
Vanderbilt UniversityNashville, Tennessee
University of Washington Medical CenterSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 16, 2019. Always confirm current availability with the study team.

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