Non-small Cell Lung Cancer Clinical Trial
Official title:
A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers: Phase 2 Randomized Trial (VALUE-CHECK)
This study is a prospective, open label, multi-centre phase 2 trial which assesses the efficacy and safety of standard dosing compared to extended dosing interval of nivolumab, atezolizumab or pembrolizumab in advanced/unresectable gastric/gastroesophageal junction/oesphageal adenocarcinomas with PDL1 CPS ≥5%, hepatocellular carcinoma andnon-small cell lung cancer with PDL1 TPS≥50% with no prior treatment. The investigators hypothesize that nivolumab, pembrolizumab and atezolizumab can be used efficiently at extended dosing intervals, compared to their approved labels with comparable clinical outcome.
This study aims to assess the noninferiority of progression free survival of standard dosing compared to extended dosing interval of nivolumab, pembrolizumab and atezolizumab in advanced/unresectable gastric/gastroesophageal junction/oesphageal adenocarcinomas with PDL1 CPS ≥5%, hepatocellular carcinoma, non-small cell lung cancer with PDL1 TPS≥50% and locally advanced/metastatic head and neck squamous cell carcinoma with PDL1 CPS ≥1% that have no prior treatment. Secondary Objective To investigate the safety, overall survival (OS) of ICI at extended dosing interval of the standard versus extended dosing interval groups. Exploratory endpoints We would detect minimal residual disease (MRD) using multiomics and compare the progress of the disease or the outcome of patients besides clinical assessments. ;
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