A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Metastatic Non-Small-Cell Lung Cancer
Categories (click each to see list of all clinical trials associated with that category): Cellular Therapy Support Service - Other CAR (ONC), Thoracic (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Ganti, Apar
Eligibility: https://clinicaltrials.gov/study/NCT04614103?term=NCT04614103&rank=1
Summary
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