Table of contents
- Trial overview
- Who can join the study
- Treatments being compared
- What the study measures
- Study size and status
- What this means for patients
Trial overview
The clinical trial listed for Hydroxocobalamin is NCT05920356, a Phase 3 interventional study in advanced non-small cell lung cancer.[1] The study title shows that it is testing front-line treatment strategies in people with PD-L1 negative, KRAS p.G12C positive disease.[1]
This trial is authorised and is designed to compare two treatment approaches in a larger group of patients.[1] The study uses randomization, which means participants are assigned to a treatment group by chance.[1]
Who can join the study
The study is for subjects with stage IV or advanced stage IIIB/C nonsquamous non-small cell lung cancer.[1] It also requires the cancer to be PD-L1 negative and KRAS p.G12C positive.[1]
In simple terms, this means the trial is focused on a specific lung cancer group with a particular gene change and a specific test result for PD-L1.[1] These details help researchers study whether one treatment plan works better than another in this exact population.[1]
Treatments being compared
The trial compares sotorasib with chemotherapy against pembrolizumab with chemotherapy.[1] The listed interventions also include carboplatin, pemetrexed, folic acid, dexamethasone, and Hydroxocobalamin as part of the treatment plan.[1]
This is not a study of Hydroxocobalamin alone.[1] Instead, Hydroxocobalamin appears in the treatment list within a broader lung cancer trial that compares two main strategies.[1]
What the study measures
The main outcome is progression-free survival (PFS).[1] PFS means the length of time from randomization until the cancer gets worse or the patient dies, whichever happens first.[1]
The study uses an independent review based on RECIST v1.1, which is a set of rules for measuring whether cancer has grown or shrunk on scans.[1] The reviewers do not know which treatment the participant received, which helps make the assessment fairer.[1]
The study also compares overall survival (OS).[1] OS means how long participants live during the study after starting treatment.[1]
Study size and status
The planned enrollment is 721 participants.[1] This means the researchers expect to include 721 people in the trial.[1]
The trial status is listed as authorised.[1] The study type is interventional, meaning the research team gives treatment and measures the results.[1]
What this means for patients
For patients, this trial is mainly about finding out which treatment approach gives better control of advanced lung cancer.[1] The focus is on people with a very specific tumor type and genetic profile, so the results may apply most directly to that group.[1]
Because the study measures both time without cancer growth and how long patients live, it is looking at both disease control and survival.[1] The trial does not provide a general description of Hydroxocobalamin itself; it only shows that Hydroxocobalamin is part of the treatment list in this lung cancer study.[1]
