Table of Contents
- Clinical trial overview
- Study design and treatment groups
- Who the trial is for
- What the trial measures
- Trial status and size
Clinical trial overview
The available trial of Vudalimab is a study in advanced non-small cell lung cancer, which is a later stage of lung cancer.[1]
This study is an interventional trial, which means participants receive a treatment plan that researchers are testing.[1]
The trial is listed as Phase 1, so it mainly focuses on early testing of safety and tolerability.[1]
Study design and treatment groups
The study compares treatment combinations that include Vudalimab or pembrolizumab with chemotherapy.[1]
The chemotherapy drugs named in the trial are pemetrexed and carboplatin, both given by intravenous infusion.[1]
The brief study summary says Part 1 is used to find the RP2D, which means the recommended Phase 2 dose.[1]
Part 2 compares Vudalimab plus chemotherapy with pembrolizumab plus chemotherapy to see which treatment better delays disease progression.[1]
Who the trial is for
The trial is for participants with advanced non-small cell lung cancer.[1]
The source data do not give more detailed entry rules, so exact eligibility cannot be fully described here.[1]
In general, people who join a clinical trial must meet the study rules for health status and diagnosis, but the exact criteria are not listed in the source data.[1]
What the trial measures
One main safety measure is the incidence of treatment-emergent adverse events, which means side effects that start after treatment begins.[1]
The study also looks at treatment-related adverse events leading to discontinuation, meaning side effects serious enough that treatment has to be stopped.[1]
The main result in Part 2 is progression-free survival (PFS), which is the time from randomization until the cancer gets worse or the participant dies, whichever happens first.[1]
The trial uses RECIST 1.1 to judge cancer progression, which is a standard way to measure changes in tumors on scans.[1]
Trial status and size
The trial status is Completed, so the study has finished enrolling and collecting its planned data.[1]
The enrollment was 168 participants.[1]
Only one trial was provided in the source data, so this article focuses on that single study of Vudalimab in lung cancer.[1]
