NCT03419559

Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combo With Durvalumab in Non-Small Cell Lung Cancer

A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Iovance Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase 2, open-label, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) in combination with Anti-PD-L1 inhibitor durvalumab.

Detailed description

LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	LN-145	adoptive cell therapy (ACT) with autologous TIL therapy
DRUG	Durvalumab	PD-L1 antagonist monoclonal antibody

Timeline

• Start date: 2018-02-28
• Primary completion: 2021-12-01
• Completion: 2024-12-01
• First posted: 2018-02-05
• Last updated: 2019-04-16

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study