Study name: TransBronchial Needle injection of Tremelimumab in early-stage NSCLC patients (TALENT)
Histology
NSCLC, all subtypes
Tumor stage
Stage I - III
Host / recruiting site 1
Amsterdam UMC
Enrollment
Recruiting
Therapy line
First line (1L)
Design
This is a single center, phase 1 / 2 randomized safety and feasibility study in which 24 patients participate for 3 months.
Intervention
Bronchoscopic transbronchial needle injection (TBNI) of Tremelimumab (n=16)/placebo(n=8) in mediastinal/hilar lymph node or primary lung tumor
Key outcome parameters
Safety and feasibility of intranodal and intratumoral TBNI
Pharmacokinetics of therapeutic antibodies in plasma after TBNI
Key inclusion criteria
Pathologically confirmed, T1-2N0M0 NSCLC
Considered a surgical lung tumor resection candidate, as determined by the pulmonologist and lung surgeons at the multidisciplinary tumor meeting.
Above 18 years of age on day of signing informed consent
Key exclusion criteria
Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of TBNI.
Additional malignancy that is progressing or requires active systemic treatment.
Active or prior documented autoimmune or inflammatory disorders
Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
Active infection requiring systemic therapy.
A history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
Active infection including tuberculosis, hepatitis B, hepatitis C.
Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Has received prior therapy with an anti-PD-1, anti-PD-L1 including durvalumab, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways in the past year.
Patient is pregnant or breastfeeding
Patients with known oncogenic drivers such as activating EGFR or BRAF mutations or ALK or ROS1 gene rearrangements
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