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NCT06455917Recrutement en cours

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

Résumé

Aim of the study is to investigate the efficacy and safety of adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TIL) in patients with advanced pre-treated non-small cell lung cancer (NSCLC).

Critères d'inclusion

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.

Critères d'exclusion

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.

Contacts

Les coordonnées de l'équipe de l'essai s'affichent sur demande.

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Statut
Recrutement en cours
Phase
Phase 2
Type d'étude
Interventionnelle
Pays
Suisse
Promoteur
University Hospital, Basel, Switzerland(Autre)
N° de protocole
2024-00254; th22Laeubli
Pathologies
Non-Small Cell Lung Cancer, Lung Cancer (NSCLC)
Interventions
Médicament

Traitements évalués

  • TILs(Tumor Infiltrating Lymphocytes)

Lieux · 1

  • Basel, SuisseDepartment of Medical Oncology, University Hospital BaselRecrute dans ce centre

Au total, dans le monde, le seul centre listé au registre recrute.

Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 19 novembre 2025).

Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.

Voir aussi

Autres versions

Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.