Tremelimumab for Non-small cell lung cancer

Stratification factors

• TBNI injection location (intranodal vs intratumoral)

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- Patients deemed inoperable\n- 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.\n- 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.\n- Patients with known oncogenic drivers such as activating EGFR or BRAF mutations or ALK or ROS1 gene rearrangements\n- 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.\n- 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.\n- 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.\tPatients with vitiligo or alopecia b.\tPatients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement c.\tAny chronic skin condition that does not require systemic therapy d.\tPatients without active disease in the last 5 years may be included but only after consultation with the study physician e.\tPatients with celiac disease controlled by diet alone\n- 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\n- Active infection requiring systemic therapy.\n- A history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).\n- 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.\n- Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial."}

Primary endpoints

• {"endpoint_text":"- Safety defined as the proportion of patients with (severe) adverse events up to the date of the scheduled surgical lung tumor resection after intra-nodal and intra-tumoral bronchoscopic administration of tremelimumab. This includes both TBNI procedure related (S)AEs and immune-related (S)AEs.","definition_or_measurement_approach":"Proportion of patients experiencing (severe) adverse events up to the date of the scheduled surgical lung tumor resection; includes both TBNI procedure-related (S)AEs and immune-related (S)AEs."}
• {"endpoint_text":"- Feasibility defined as successful injection of tremelimumab or saline in the tumor draining lymph node or tumor.","definition_or_measurement_approach":"Feasibility measured as successful injection of tremelimumab or saline into the tumor-draining lymph node or tumor."}

Secondary endpoints

• {"endpoint_text":"- Pharmacokinetics assessment: levels of therapeutic antibodies in plasma at multiple time points (baseline, 2 hours post TBNI procedure, 1 day post TBNI, 14 (+/- 5 days) days post TBNI and 12 weeks (+/- 7 days) after surgical lung tumor resection ).","definition_or_measurement_approach":"Measurement of therapeutic antibody plasma levels at baseline, 2 hours post-TBNI, 1 day post-TBNI, ~14 days post-TBNI (±5 days), and ~12 weeks post-surgical resection (±7 days)."}

Netherlands

Earliest CTIS Part Ii Submission Date

14-10-2024

Latest Decision Or Authorization Date

21-10-2024

Processing Time Days

7

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Cancer Center Amsterdam (CCA)","duties_or_roles":"Source of monetary support","organisation_type":""}