Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer
18 - 70 Years, Male and Female
IOV-LUN-202 (primary)
NCI-2020-11568
2020-003629-45
2024-510778-26-00
Summary
This is a prospective, open-label, multi-cohort, non-randomized, multicenter phase 2
study evaluating LN-145 in patients with metastatic non-small-cell lung cancer
Objectives
LN-145 is a ready-to-infuse 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 a non-myeloablative (NMA) lymphodepleting preparative
regimen, followed by infusion of autologous TIL, then finally followed by the
administration of IL-2.
Eligibility
- 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
Treatment Sites in Georgia
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