Non small cell lung cancer
Conditions
Brief summary
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., Feasibility defined as successful injection of tremelimumab or saline in the tumor draining lymph node or tumor.
Detailed description
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 ).
Interventions
DRUGIMJUDO 20 mg/ml concentrate for solution for infusion.
Sponsors
Amsterdam UMC Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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 ). | — |
Primary
| Measure | Time frame |
|---|---|
| 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., Feasibility defined as successful injection of tremelimumab or saline in the tumor draining lymph node or tumor. | — |
Countries
Netherlands
Outcome results
None listed