Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer

Conditions

• Metastatic Non Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• LN-145 — BIOLOGICAL
  A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, patient is infused with autologous TIL (LN-145), followed by IL-2.
• LN-145 — BIOLOGICAL
  A tumor sample is obtained by image-guided core biopsy from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, patient is infused with autologous TIL (LN-145) followed by IL-2.

Study Details

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

Key Dates

Start date

May 7, 2021

Status verified

Apr 2026

Primary completion

Dec 31, 2030

Completion

Dec 31, 2031

Study Design

Enrollment

170 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1
  Patients whose tumors did not express programmed cell death-ligand 1 (PD-L1), i.e., tumor proportion score (TPS) \< 1% prior to ICI treatment and Patients with no available historical TPS for PD-L1 expression
• Experimental: Cohort 2
  Patients whose tumors expressed PD-L1 TPS ≥1% prior to ICI treatment
• Experimental: Cohort 3
  Patients, regardless of tumor PD-L1 TPS prior to ICI treatment, who are unable to safely undergo a surgical tumor resection for TIL generation
• Experimental: Cohort 4
  Patients, regardless of tumor PD-L1 expression status prior to ICI treatment, who have meet all inclusion/exclusion criteria except the requirement to have documented disease progression may elect to have the tumor harvest procedure and TIL production prior to disease progression on their current anticancer treatment. Documentation of progressive disease and identification of a target lesion for RECIST v1.1 assessment is required at Baseline for these patients.
• Experimental: Retreatment Cohort
  Patients who were previously treated with LN-145 in Cohort 1, 2, 3, or 4.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Up to 60 months ]

Central Contacts

• Iovance Biotherapeutics Study Team lungcelltherapy.com
  1-844-845-4682
  [email protected]

Locations (46)

Find similar trials in Gilbert, AZ

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