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

NCT06455917 | Recruiting Phase 2 DMC

• 1 other identifier: 2024-00254; th22Laeubli
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Non-Small Cell Lung Cancer; Lung Cancer (NSCLC)

Keywords

tumor-infiltrating lymphocytes; adoptive cell therapy

Outcome Measures

Primary Outcomes (1)

• Progression-free rate at 6 months after Tumor-infiltrating lymphocytes transfer.

  Progression-free rate (PFR) (RECIST v1.1 / iRECIST) at 6 months after TIL transfer, defined by the Kaplan-Meier estimator for progression-free survival (RECIST v1.1 / iRECIST) at 6 months (+/- 4 weeks as we allow this interval in the tumor assessment at 6 months).

  5-7 months after TIL transfer

Secondary Outcomes (7)

• Progression-free survival (PFS)

  up to one year after TIL transfer

• Overall survival (OS)

  up to one year after TIL transfer

• Severity of adverse events (CTCAE v5.0 criteria)

  up to one year after TIL transfer

• Objective response rate (ORR)

  up to one year after TIL transfer

• Duration of response (DOR)

  up to one year after TIL transfer

Study Arms (1)

Tumor-infiltrating lymphocyte product (TIL) transfer

EXPERIMENTAL

Tumor-specific T cells are expanded from excised tumor samples and stimulated in cell culture with interleukin-2 (IL-2). The resulting autologous TILs are then re-infused to the patient after a non-myeloablative lymphodepleting chemotherapy with cyclophosphamide and fludarabine. Activation of TILs in the patient is then supported by IL-2 administration. The transplant product will be produced in the Good Manufacturing Practice (GMP) facility of the University Hospital in Basel.

Drug: TILs（Tumor Infiltrating Lymphocytes）

Interventions

TILs（Tumor Infiltrating Lymphocytes） DRUG

The study procedures are: * Tumor collection: Study-specific intervention (eg, surgical resection and/or biopsy) to collect tumor material from one or more tumor lesions/metastases for the generation of the TIL product (tumor-infiltrating lymphocytes, TILs). * TIL expansion: Production of the TIL product in the Good-Manufacturing-Practice (GMP) Facility for Advanced Therapies of the University Hospital of Basel. * Lymphodepleting chemotherapy (lymphodepletion): Chemotherapy with cyclophosphamide and fludarabine (day -7 until day -3). * TIL transfer: Infusion of the TIL product back to the patient. TIL transfer is scheduled on day 0. * Interleukin-2 (IL-2) therapy: Therapy with high-dose IL-2 (Aldesleukin) every 8 hours for up to 15 doses. IL-2 therapy starts on day 0.

Tumor-infiltrating lymphocyte product (TIL) transfer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 (cf. Appendix).
• Histologically confirmed NSCLC.
• Disease progression after at least one standard therapy and without any approved curative-intended treatment option.
• Accessible tumor lesion/metastasis for tumor collection.
• Willingness of the patient to undergo a surgical intervention (eg, surgical resection and/or biopsy) to collect one or more tumor lesions/metastases.
• 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.
• Negative serum pregnancy test in women of childbearing potential, in peri-menopausal women and in women with less than 2 years of menopause.

You may not qualify if:

• Active central nervous system (CNS) metastases. Patients with stable CNS metastases ≥ 1 month after definitive treatment (eg, surgery and/or radiotherapy) are eligible.
• Participants with an active second malignancy.
• 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.
• Prior immune-related adverse events that would preclude re-challenge with an immune checkpoint inhibitor or immunomodulatory agent per investigator's judgment.
• Immunosuppressive treatment that would preclude the patient from any of the study therapies per investigator's judgment.
• Severe active infections or uncontrolled infectious conditions requiring treatment.
• Any other conditions/diseases, allergies, dysfunctions, and/or findings, that would contraindicate the use of any of the study interventions or therapies.
• Contraindication for any of the planned measures, interventions and/or treatments.
• 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.
• Known hypersensitivity to any of study therapies or drugs used for TIL production.
• Known human immunodeficiency virus (HIV) infection (or tests positive for HIV 1 or 2 at Screening).
• Known hepatitis B or hepatitis C infection.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Medical Oncology, University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• David König, Dr. med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David König, Dr. med.

CONTACT

+41 61 265 5074; david.koenig@usb.ch

Heinz Läubli, Prof. Dr. med.

CONTACT

+41 61 265 5074; heinz.laeubli@usb.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: January 22, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)