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

The purpose of this study is to find out whether an investigational product, called LN-145, is safe and effective in the treatment of patients with Non-Small-Cell Lung Cancer (NSCLC). LN-145 is created by modifying your own cells and delivering them back in an infusion. This study is being sponsored by Iovance Biotherapeutics.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)
  • Visits can be combined with regular clinical appointments

Location

United States (Nationwide)

What will be asked of you

You will be screened, which may occur over multiple visits. Procedures will be done to see if you are a good fit for the study and if you can continue to the tumor harvest visit. Blood and urine will be collected for routine testing. If you meet the requirements, you will be moved forward to a visit to remove a piece or pieces of your tumor. Your eligibility to continue to receive the LN-145 will be assessed during the next phase of the study which can last between 1 and 12 months after your tumor harvest visit and may occur over multiple visits. If your tumor-infiltrating cells are growing and able to produce the LN-145, you will move on to next steps of pre-conditioning chemotherapy where we'll continue to assess your eligibility, The study treatment period starts at your pre-conditioning chemotherapy treatment. This period consists of 9 to 10 days of study therapy. Then, you will receive a single dose of LN-145 by IV infusion followed by up to 6 doses of IL-2 by IV infusion over the course of the next 1 to 4 days. You will be in the hospital for the LN-145 and IL-2 infusions, and you may remain in the hospital until the study doctor decides you can go home. We will continue to follow you for up to 5 years.

Incentives

Reimbursement for parking, meals and travel (hotel, mileage, and long distance travel)

In-person visits:
Variable - up to 27 visits
Phone or online visits:
Variable - based on worsened disease
Total length of participation:
Up to 5 years - this includes treatment and follow up

Looking for Specific Volunteers

Able to participate:

  • Confirmed diagnosis of non-small cell lung cancer (NSCLC); cannot have evidence of EGFR, ALK or ROS gene alterations; must be Stage IV
  • If tumor is harvested after disease progression, documented progressive disease after first-line therapy is required
  • Presence of at least 1 site of disease that is able to be measured to evaluate response to treatment (different than tumor biopsy site)
  • Willingness to comply with study requirements (agree to biopsy, being admitted between 4-7 days, etc.)
  • Adequate performance status (ability to perform daily tasks) and organ function

Not eligible if:

  • Use of corticosteroids at doses of 10 mg or more of prednisone (or its equivalent)
  • History of allogeneic (source is another person) organ transplant or any form of cell therapy involving a chemotherapy regimen within the last 20 years
  • Symptomatic untreated brain metastases
  • Evidence on an electrocardioagram (ECG) of significant abnormalities with the rhythm of the heart; persistent cardiac chest pain; symptomatic heart failure (fatigue, palpitation or
  • Washout exclusions related to prior treatments

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Jared Weiss
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Lung)

IRB Number

21-0457

ClinicalTrials.gov

NCT04614103

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