Study of LN 145 in patients with Metastatic Non-Small-Cell Lung Cancer

• Research type

  Research Study

• Full title

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

• IRAS ID

  292831

• Contact name

  Andrew Furness

• Contact email

  andrew.furness@rmh.nhs.uk

• Sponsor organisation

  Iovance Biotherapeutics, Inc.

• Eudract number

  2020-003629-45

• Clinicaltrials.gov Identifier

  NCT04614103

• Duration of Study in the UK

  5 years, 7 months, 17 days

• Research summary

  The study is designed to evaluate Adoptive Cell Therapy (ACT) with tumour infiltrating lymphocytes (TIL) in patients with metastatic non-small-cell lung cancer. The study drug (called LN-145) is an autologous TIL derived from an individual patient's tumour for patient-directed therapy. The TIL is made up of specialised white blood cells called T cells which help the body fight infection and can help destroy cancer cells.

  The study will consist of the following 5 periods:
  - screening
  - pre-treatment
  - treatment
  - post-treatment follow-up
  - long-term follow-up

  Study participation for each patient is expected to be completed approximately 5 years after treatment. There could be a total of up to 27 visits during the study. Participants will be assigned to a cohort (treatment group) that matches their disease type.

  Eligible participants will have surgery to remove a piece or pieces of tumour. The tumour sample will be shipped to a central manufacturing facility for processing and generation of the study drug (TIL, LN-145).

  The study drug is then sent to the study site where it is administered to the participant with other medications that together make up the study therapy. Chemotherapy medications (cyclophosphamide and fludarabine) are given as a preconditioning treatment prior to the TIL infusion. This prepares the body to receive the TIL cells to have the best opportunity to attack the tumour. After the TIL infusion, participants will receive a medication called interleukin-2 which helps the infused cells to be more effective against cancer cells.

  Study procedures include tumour biopsy, CT and MRI scans, heart scans, blood samples, questionnaires and ECG.

  Approximately 95 participants will be recruited globally, 5 participants are expected to be recruited in the UK.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  21/SC/0129

• Date of REC Opinion

  16 Jun 2021

• REC opinion

  Further Information Favourable Opinion