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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 13 Aug 2024

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At a glance

  • Drugs LN 145 (Primary) ; Aldesleukin; Cyclophosphamide; Fludarabine
  • Indications Adenocarcinoma; Carcinoma; Non-small cell lung cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Iovance Biotherapeutics

    • Most Recent Events

    • 08 Aug 2024 According to an Iovance Biotherapeutics media release, company expects to complete enrollment and report topline data from the registrational cohorts in IOV-LUN-202 in 2025 to support a potential supplemental biologics license application for lifileucel in 2026 for potential accelerated approval.
    • 09 May 2024 According to an Iovance Biotherapeutics media release, At a recent Type D meeting, the FDA provided positive regulatory feedback on the proposed potency matrix for lifileucel in NSCLC. The FDA previously provided positive regulatory feedback that the design of the single-arm IOV-LUN-202 trial may be acceptable for approval of lifileucel in post-anti-PD-1 NSCLC.
    • 08 May 2024 Planned End Date changed from 1 Dec 2026 to 1 Dec 2031.

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