TUMOR INFILTRATING LYMPHOCYTE (TIL) therapy is derived from a patient’s own immune cells called lymphocytes that have come to the site of tumor to kill the tumor.
The TIL therapy under investigation in this clinical trial, LN-145, is expanded and rejuvenated TIL that was extracted from the patient’s own tumor.
ADDITIONAL INFORMATION ABOUT TIL:
- Data from multiple academic center trials in non-small cell lung cancer (NSCLC) show a positive association between the presence of TIL in NSCLC tumors and patient outcomes. A clinical study run by H. Lee Moffitt Cancer Center showed durable complete responses with Moffitt’s TIL in patients with NSCLC who progressed on nivolumab treatment.1,2
- For more information about clinical results with TIL therapies, please visit our Publication And Scientific Presentations page here.
- To learn more about TIL, please visit our Iovance TIL technology page here.
CLINICAL TRIAL OVERVIEW
IOV-LUN-202 is a Phase 2 clinical trial of Iovance TIL therapy (LN-145), enrolling patients that have been diagnosed with histologically confirmed recurrent or metastatic non-small cell lung cancer (NSCLC) across the following four cohorts:
- Cohort 1: NSCLC patients whose tumors do not express PD-L1, are without a known driver mutation, who have received a single line of approved systemic therapy (combined checkpoint inhibitor (CPI) + chemotherapy ± bevacizumab). Patients must meet study requirements for tumor resection.
- Cohort 2: NSCLC patients whose tumors express PD-L1, are without a known driver mutation, who have received a single line of approved systemic therapy (CPI + chemotherapy ± bevacizumab). Patients must meet study requirements for tumor resection.
- Cohort 3: NSCLC patients whose tumors do not express PD-L1, are without a known driver mutation, who have received a single line of approved systemic therapy (CPI + chemotherapy ± bevacizumab). Patients should not meet study requirements for surgical tumor resection and their TIL will be grown from a tumor biopsy sample instead.
- Cohort 4: LN-145 retreatment in patients who were previously treated in Cohorts 1-3.
The clinical trial is designed to determine if Iovance investigational TIL therapy is safe and effective for the treatment of various patient populations with NSCLC. There are several objectives to the trial, some of which aim to determine:
- Whether LN-145 is safe.
- Whether LN-145 helps reduce the size of a patient’s tumor(s).
- Whether LN-145 reduces or slows the progression of NSCLC.
- Whether LN-145 eliminates all detectable NSCLC.
- Whether LN-145 extends the life of a patient without their cancer worsening.
- Whether LN-145 can be successfully generated from core biopsies.
LN-145 is an investigational therapy that is being tested in clinical studies and has not been approved by the FDA or any other agency for any indication. A clinical trial is designed to explore efficacy and safety of experimental therapies. You should talk to your doctor about the benefits and risks of participating in this trial.
YOU MAY QUALIFY FOR THE TRIAL IF:
- You have been diagnosed histologically with locally advanced or metastatic NSCLC
- You are at least 18 years old
- You have documented PD-L1 expression status
- You have received a single line of systemic therapy that included CPI and chemotherapy, with a minimum washout period of 21 days
- You meet specified lab parameters
- You meet the requirements for having a resectable lesion (or aggregate lesions) or qualify for tumor harvest via core biopsy
If you satisfy these key eligibility criteria, you may be eligible to participate in this clinical trial. There are other additional eligibility criteria that can only be assessed by a trial physician.
To learn more about the trial, please call: 1-866-565-4410
Further details for healthcare providers can be accessed below:
1Creelan, et. al, AACR Virtual Meeting I 2020
2Creelan B, et al. Safety and Clinical Activity of Adoptive Cell Transfer Using Tumor Infiltrating Lymphocytes (TIL) Combined with Nivolumab in NSCLC. Journal of Thoracic Oncology 13(10):S330-S331.