In short
Clinical trials are studying Vudalimab in people with advanced non-small cell lung cancer. These studies aim to check safety, tolerability, and whether Vudalimab with chemotherapy can help control the disease better than pembrolizumab with chemotherapy.
Key points
- Clinical trials of Vudalimab are studying advanced non-small cell lung cancer. The main trial is a Phase 1 study with 168 participants. It first looks at safety, tolerability, and the best dose when Vudalimab is given with chemotherapy. It also compares progression-free survival between Vudalimab plus chemotherapy and pembrolizumab plus chemotherapy. The trial is completed and focuses on whether the treatment can help delay cancer growth.
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.
This study is an interventional trial, which means participants receive a treatment plan that researchers are testing.
The trial is listed as Phase 1, so it mainly focuses on early testing of safety and tolerability.
Study design and treatment groups
The study compares treatment combinations that include Vudalimab or pembrolizumab with chemotherapy.
The chemotherapy drugs named in the trial are pemetrexed and carboplatin, both given by intravenous infusion.
The brief study summary says Part 1 is used to find the RP2D, which means the recommended Phase 2 dose.
Part 2 compares Vudalimab plus chemotherapy with pembrolizumab plus chemotherapy to see which treatment better delays disease progression.
Who the trial is for
The trial is for participants with advanced non-small cell lung cancer.
The source data do not give more detailed entry rules, so exact eligibility cannot be fully described here.
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.
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.
The study also looks at treatment-related adverse events leading to discontinuation, meaning side effects serious enough that treatment has to be stopped.
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.
The trial uses RECIST 1.1 to judge cancer progression, which is a standard way to measure changes in tumors on scans.
Trial status and size
The trial status is Completed, so the study has finished enrolling and collecting its planned data.
The enrollment was 168 participants.
Only one trial was provided in the source data, so this article focuses on that single study of Vudalimab in lung cancer.