Treatment of patients with non-small cell lung cancer using tumor-infiltrating lymphocytes (TILs).
Summary description of the study
In our study, we want to find out whether treatment of your cancer with your body's immune cells (called tumor-infiltrating lymphocytes, TILs) can halt the progression of your disease and whether this therapeutic concept is safe. Patient participation in this study will last about 14 months (treatment of about 2 months, follow-up of 12 months). As part of the treatment, we will invite patients to various study visits (control examinations, therapies). No visits are planned during the follow-up period, but we will contact you regularly. Study visits take varying amounts of time. Outpatient appointments last about 30-90 minutes. The TIL therapy takes place over several days in the clinic. For enrolled patients, initial assessments and examinations will be conducted to check health status and eligibility for the study. If the patient qualifies for the study, various treatment steps will be carried out: First, tumor tissue will be removed through a surgical procedure to obtain immune cells (TILs). The TILs will then be isolated, processed, and multiplied in the laboratory. This takes about 1 month. The TIL therapy includes a preparatory chemotherapy, the return of the laboratory-multiplied TILs, and a follow-up therapy with the immune-stimulating agent interleukin-2. The treatment lasts about 14 to 21 days in the hospital.
(BASEC)
Intervention under investigation
In our study, all participants receive the same treatment. This is an open-label study, meaning that both the patient and the investigators know which treatment the patient will receive.
Our study proceeds as follows:
- Pre-examination: You will undergo examinations to determine your health status and eligibility for the study.
- Removal of tumor tissue: Tumor tissue will be removed through a surgical procedure to obtain TIL cells. The TIL cells will then be isolated, multiplied, and activated in a specialized laboratory at the University Hospital Basel.
- TIL treatment: You will receive a preparatory chemotherapy, followed by an infusion of the multiplied and activated TIL cells, then a follow-up therapy with the immune-stimulating substance interleukin-2.
- Follow-up: If necessary, you will be contacted to obtain information about your health status and your disease.
(BASEC)
Disease under investigation
non-small cell lung cancer.
(BASEC)
- Histologically confirmed non-small cell lung tumor - Progression of the disease after at least one standard therapy and without approved curative treatment options. - Accessible tumor lesion/metastasis for tumor sampling. (BASEC)
Exclusion criteria
- Active metastases of the central nervous system (CNS). - Participants with an active second malignant disease. - Signs of significant, uncontrolled comorbidities that could affect adherence to the study protocol, including autoimmune diseases or immunodeficiency, significant lung diseases, significant cardiac and/or vascular diseases at the discretion of the investigator. (BASEC)
Trial sites
Basel
(BASEC)
Sponsor
University Hospital Basel
(BASEC)
Contact
Contact Person Switzerland
David König
+41 61 265 50 74
david.koenig@clutterusb.chDepartment of Medical Oncology, University Hospital Basel Petersgraben 4 4031 Basel
(BASEC)
General Information
University Hospital, Basel, Switzerland,
+41 61 265 5074;+41 61 265 50 74
david.koenig@clutterusb.ch(ICTRP)
Scientific Information
University Hospital, Basel, Switzerland,
+41 61 265 5074;+41 61 265 50 74
david.koenig@clutterusb.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
20.06.2024
(BASEC)
ICTRP Trial ID
NCT06455917 (ICTRP)
Official title (approved by ethics committee)
A phase II trial of Adoptive Cell Therapy with Tumor-infiltrating Lymphocytes in patients with Non-Small Cell Lung Cancer. The BaseTIL-02L trial (BASEC)
Academic title
A Phase II Trial of Adoptive Cell Therapy With Tumor-infiltrating Lymphocytes in Patients With Non-Small Cell Lung Cancer (ICTRP)
Public title
TIL Therapy in Non-small-cell Lung Cancer (NSCLC) Patients (ICTRP)
Disease under investigation
Non-Small Cell Lung Cancer (ICTRP)
Intervention under investigation
Drug: Combination of TIL Transfer and low dose IL-2 (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
1. Ability of the patient to understand the purpose of the study, provide signed and
dated informed consent prior to performing any protocol-related procedures
(including screening evaluations), and be able and willing to comply with the study
procedures.
2. Age = 18 years.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 (cf. Appendix).
4. Histologically confirmed NSCLC.
5. Disease progression after at least one standard therapy and without any approved
curative-intended treatment option.
6. Accessible tumor lesion/metastasis for tumor collection.
7. Willingness of the patient to undergo a surgical intervention (eg, surgical
resection and/or biopsy) to collect one or more tumor lesions/metastases.
8. Adequate organ function (pulmonary, cardiovascular, hematological, hepatic, and
renal function) per investigator's judgment. Cardiac stress testing is required for
all patients with underlying cardiac conditions and patients with age = 50 years.
9. Negative serum pregnancy test in women of childbearing potential, in peri-menopausal
women and in women with less than 2 years of menopause.
Exclusion Criteria:
1. Active central nervous system (CNS) metastases. Patients with stable CNS metastases
= 1 month after definitive treatment (eg, surgery and/or radiotherapy) are eligible.
2. Participants with an active second malignancy.
3. Evidence of significant, uncontrolled concomitant diseases that could affect
compliance with the protocol, including autoimmune or immunodeficient conditions,
significant pulmonary disease, significant cardiac and/or vascular disease per
investigator's judgment.
4. Prior immune-related adverse events that would preclude re-challenge with an immune
checkpoint inhibitor or immunomodulatory agent per investigator's judgment.
5. Immunosuppressive treatment that would preclude the patient from any of the study
therapies per investigator's judgment.
6. Severe active infections or uncontrolled infectious conditions requiring treatment.
7. Any other conditions/diseases, allergies, dysfunctions, and/or findings, that would
contraindicate the use of any of the study interventions or therapies.
8. Contraindication for any of the planned measures, interventions and/or treatments.
9. Pregnant or breastfeeding women, or female subject who are not willing to use an
acceptable, highly effective method of contraception until the End-of-Study visit.
10. Known hypersensitivity to any of study therapies or drugs used for TIL production.
11. Known human immunodeficiency virus (HIV) infection (or tests positive for HIV 1 or 2
at Screening).
12. Known hepatitis B or hepatitis C infection. (ICTRP)
not available
Primary and secondary end points
Progression-free rate at 6 months after Tumor-infiltrating lymphocytes transfer. (ICTRP)
Progression-free survival (PFS);Overall survival (OS);Severity of adverse events (CTCAE v5.0 criteria);Objective response rate (ORR);Duration of response (DOR);Frequency of adverse events (number);Incidence of adverse events (%) (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
David K?nig, MD;David K?nig, MD;David K?nig, MD, david.koenig@usb.ch, +41 61 265 5074;+41 61 265 50 74, University Hospital, Basel, Switzerland, (ICTRP)
Secondary trial IDs
2024-00254, th22Laeubli (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06455917 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available