| Histology |
NSCLC, all subtypes
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| Tumor stage |
Stage I - III |
| Host / recruiting site 1 |
Amsterdam UMC
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Enrollment |
Recruiting
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| Therapy line |
First line (1L)
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| Design |
This is a single center, phase 1 / 2 randomized safety and feasibility study in which 24 patients participate for 3 months.
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| Intervention |
Bronchoscopic transbronchial needle injection (TBNI) of Tremelimumab (n=16)/placebo(n=8) in mediastinal/hilar lymph node or primary lung tumor
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| Key outcome parameters |
- Safety and feasibility of intranodal and intratumoral TBNI
- Pharmacokinetics of therapeutic antibodies in plasma after TBNI
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| 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
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| 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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| Contact information |
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