Clinical Trial 21027

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT04614103

Phase: Phase II
Principal Investigator: Creelan, Benjamin

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Overview

Study Title

A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Metastatic Non-Small-Cell Lung Cancer

Summary

LN-145 is a ready-to-infuse, autologous TIL therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI and further optimized by Iovance for the treatment of patients with metastatic NSCLC. The cell transfer therapy used in this study involves patients receiving an NMA lymphocyte depleting preparative regimen, followed by infusion of autologous TIL, then finally followed by the administration of IL-2.

Objective

Primary Objective: To evaluate the efficacy of LN-145 in patients with metastatic NSCLC without an actionable driver mutation who have disease progression on or following a single line of approved systemic therapy consisting of combined immune checkpoint inhibitor(s) (CPI[s]) + chemotherapy ± bevacizumab, as determined by objective response rate (ORR), using the RECIST v1.1, as assessed by the Independent Review Committee (IRC) (Cohorts 1 and 2) or by the Investigator (Cohorts 3 and 4) Secondary Objectives: To evaluate the efficacy of LN-145, as determined by ORR, using RECIST v1.1, as assessed by the Investigator (Cohorts 1 and 2 only) To further evaluate the efficacy of LN-145 using complete response (CR) rate; duration of response (DOR); disease control rate (DCR); progression-free survival (PFS) using RECIST v1.1, as assessed by the IRC (Cohorts 1 and 2 only) and Investigator (all cohorts); and overall survival (OS) To characterize the safety profile of LN-145 in NSCLC patients, as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs) For Cohort 3 only: To evaluate the efficiency of generating LN-145 from tumor core biopsies Exploratory Objectives: To evaluate the persistence of LN-145 and to identify immune correlates that may correlate with response, outcome, and toxicity variables To assess respective, indication-specific, health-related quality of life (HRQoL) parameters

Treatments

Therapies

Cell Therapy; Chemotherapy (NOS); Immunotherapy; Therapy (NOS)

Medications

Acyclovir (); Diphenhydramine (); Fluconazole (); H1 Histamine Antagonist (); IL-2 (Interleukin-2); LN-145 (); MESNA (); Neupogen (filgrastim); Valacyclovir (); acetaminophen (); cyclophosphamide (); cytoxan (cyclophosphamide); filgrastim ()

Inclusion Criteria

Confirmed histologic diagnosis of Non-Small-Cell Lung Carcinoma confirmation

Have received a single line of systemic therapy that included CPI and chemotherapy with documented radiographic disease progression on or following this single line of systemic therapy

LVEF > 45%, NYHA Class 1; cardiac stress test required

FEV1>50% or FEV1/FVC>0.7 (6 min walk test if unable to perform or unreliable spirometry)

At least 1 resectable lesion

Previously irradiated lesion must have radiographic progression prior to harvest

Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and an estimated life expectancy of > 6 months

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 for 12 months after receiving all protocol-related therapy.

Exclusion Criteria

Patients who have known oncogene driver mutations (eg, EGFR, ALK, ROS) which are sensitive to targeted therapies

Patients who have symptomatic and/or untreated brain metastases

Patients who have organ allograft or prior cell transfer within the past 20 years

Patients who are on systemic steroid therapy > 10 mg/day of prednisone or other steroid equivalent. Patients receiving steroids as replacement therapy for adrenocortical insufficiency at > Patients who have any form of primary immunodeficiency

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 of the initiation of treatment

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