AIO-TRK/YMO-0425 (High Five) is a phase III, open-label randomized-controlled, multicenter study to evaluate the progression-free survival by the addition of platinum-based chemotherapy to immunotherapy (IO) compared to IO monotherapy in patients with PD-L1high mNSCLC featuring a high tumor burden.
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
Histologically confirmed and treatment-naïve non-small cell lung cancer UICC 9th stage IV
PD-L1 ≥ 50%
High Tumor Burden defined as the longest diameter of the tumor or at least one metastasis ≥ 50mm and no eligibility for a curative treatment approach
Presence of a condition, disease or abnormality that in the opinion of the Investigator would compromise the safety of the patient, the patient's ability to comply with the study procedures (e.g., dementia) or the quality of the data. Specifically, the presence of any preexisting autoimmune disease that prohibits dosing of IMP as per treatment modification guidelines in the current IB/SmPC
Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study, or during the follow-up period of an interventional study
Concurrent malignancy other than NSCLC requiring active treatment
Has known hypersensitivity to the IMPs or to any component of the planned regimen, their metabolites, or formulation excipients, or any other contraindication to any component of the planned study regimen according to the tislelizumab IB and the relevant SmPCs
Parallel
Tislelizumab
DrugTislelizumab monotherapy 200 mg i.v. q3w
Tislelizumab Combined With Chemotherapy
DrugNon-squamous NSCLC: tislelizumab 200 mg i.v. + platinum-based chemotherapy (cisplatin 75 mg/m2 i.v. or carboplatin AUC 5-6 i.v.) + pemetrexed 500 mg/m2 i.v.; squamous NSCLC: tislelizumab 200 mg i.v. + carboplatin AUC 5-6 i.v. + (nab)paclitaxel (nab-paclitaxel 100 mg/m2 i.v., paclitaxel 175 or 200 mg/m2 i.v.
Pembrolizumab
DrugPembrolizumab monotherapy 200 mg i.v. q3w
Progression-free survival
time from randomization to the date of first objective disease progression (according to RECIST V1.1) or death of any cause, whichever occurs first.
Overall survival
Objective response rate
rate of patients with complete response (CR) or partial response (PR) as best response
Duration of response
Disease control rate
Click on the lead sponsor to view all of their trials.
AIO-Studien-gGmbH
Lead sponsor
BeOne Medicines
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
