Table of contents
- Overview of the Rmc-6291 study
- Who the trial is for
- Treatments being tested
- Trial phase and study design
- What the study measures
- What the medical terms mean
Overview of the Rmc-6291 study
The main trial in the source data is NCT06162221, a study of Rmc-6291 and RMC-6236 with other anti-cancer agents in patients with RAS G12C-mutated NSCLC (non-small cell lung cancer).[1] The study is authorised and is being done to learn about safety and tolerability in advanced cancer.[1]
The brief summary says the study also aims to define the RP2DS, which means the recommended phase 2 dose and schedule, for Rmc-6291 when used with pembrolizumab, with or without RMC-6236 and with or without chemotherapy.[1]
Who the trial is for
This study is focused on people with advanced RAS G12C-mutated solid tumors, and one key group is patients with advanced RAS G12C-mutated NSCLC.[1] In simple words, this means the trial is for people whose cancer has a specific gene change called RAS G12C and is at an advanced stage.[1]
The data do not list full inclusion or exclusion rules, so participation depends on the detailed trial criteria used by the study team.[1]
Treatments being tested
The study tests Rmc-6291 in combination with pembrolizumab, and in some parts it may also include RMC-6236 and chemotherapy.[1] The chemotherapy drugs named in the trial record include pemetrexed, cisplatin, and carboplatin.[1]
This means the researchers are not only looking at Rmc-6291 alone, but at how it works as part of a treatment combination in advanced cancer.[1]
Trial phase and study design
NCT06162221 is a Phase 1 study, which is an early stage of clinical research.[1] Phase 1 trials usually focus on safety, tolerability, and dose finding rather than proving long-term benefit.[1]
The study type is interventional, which means the researchers assign treatments and then observe what happens.[1] The planned enrollment is 267 participants.[1]
What the study measures
The primary outcome includes the incidence of dose-limiting toxicities (DLTs) in selected parts of the study.[1] A dose-limiting toxicity is a side effect that is serious enough to limit how much treatment can be given.[1]
The trial also measures treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), and clinically significant changes in laboratory test values, ECGs, and vital signs.[1] These measures help the team understand whether the treatment is causing safety problems during the study.[1]
What the medical terms mean
NSCLC stands for non-small cell lung cancer, which is a common type of lung cancer.[1] RAS G12C mutation means a specific change in a cancer-related gene, and the study only looks at cancers with this change.[1]
ECG means electrocardiogram, a test that checks the heart’s electrical activity.[1] Vital signs are basic body measurements such as pulse, blood pressure, and temperature, which help show how a person is doing during treatment.[1]
Laboratory test values are results from blood or other tests that help the team watch for safety changes during the trial.[1]
