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

Iovance Biotherapeutics

Status and phase

Withdrawn

Phase 2

Conditions

Non Small Cell Lung Cancer

Treatments

Biological: LN-145

Drug: Durvalumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03419559

IOV-LUN-201

Details and patient eligibility

About

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.

Full description

LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion 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

Exclusion 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