TransBronchial Needle injection of Tremelimumab in early-stage NSCLC patients (TALENT)

Trial details

Who runs it

Amsterdam UMC Stichting

Trial code

EU 2024-511878-67-00

Record updated

2024. október 21.

Original description

To study the safety and feasibility of intra-nodal and intra-tumoral bronchoscopic transbronchial needle injection (TBNI) of tremelimumab in early-stage NSCLC patients.Read full original descriptionShow less

To study the safety and feasibility of intra-nodal and intra-tumoral bronchoscopic transbronchial needle injection (TBNI) of tremelimumab in early-stage NSCLC patients.

Inclusion: Pathologically confirmed, T1-2N0M0 NSCLC scheduled for surgical lung tumor resection; Willing and able to provide written informed consent for the trial; Above 18 years of age on day of signing informed consent; Considered a surgical lung tumor resection candidate, as determined by the pulmonologist and lung surgeons at the multidisciplinary tumor meeting.

Exclusion: 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; Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease; Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion: a. Patients with vitiligo or alopecia b. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement c. Any chronic skin condition that does not require systemic therapy d. Patients without active disease in the last 5 years may be included but only after consultation with the study physician e. Patients with celiac disease controlled by diet alone; Additional malignancy that is progressing or requires active systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy; Uncontrolled intercurrent illness, including but not limited to symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations 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 (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA; Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial; Patients with known oncogenic drivers such as activating EGFR or BRAF mutations or ALK or ROS1 gene rearrangements; Patients deemed inoperable; Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the pre-screening or screening visit through 23 weeks after the bronchoscopy.

EU CTIS 2024-511878-67-00