Treatment of patients with non-small cell lung cancer using tumor-infiltrating lymphocytes (TILs).

Switzerland (ICTRP)

ID di studio ICTRP
NCT06455917 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
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)

Titolo accademico
A Phase II Trial of Adoptive Cell Therapy With Tumor-infiltrating Lymphocytes in Patients With Non-Small Cell Lung Cancer (ICTRP)

Titolo pubblico
TIL Therapy in Non-small-cell Lung Cancer (NSCLC) Patients (ICTRP)

Malattie studiate
Non-Small Cell Lung Cancer (ICTRP)

Intervento studiato
Drug: Combination of TIL Transfer and low dose IL-2 (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
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)

non disponibile

Endpoint primari e secondari
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)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
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)

ID secondari
2024-00254, th22Laeubli (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06455917 (ICTRP)