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

Cancer Categories

Lung

Karmanos Trial ID

2020-132

NCT ID

NCT04614103

Age Group

Adult

Scope

National

Phase

Phase II

Principal Investigator

Tarik
Hadid, M.D., MPH, MS, FACP
Oncology - Medical View Profile

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 greater than or equal to 3 treatment-emergent adverse events (TEAEs)
For Cohort 3 only: To evaluate the efficiency of generating LN-145 from tumor core biopsies

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Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices