Table of Contents
- Trial overview
- Who the study is for
- What the study is testing
- Study phase and size
- What the study measures
- What the trial means for patients
Trial overview
The available trial is NCT06162221, a Phase 1 interventional study of Rmc-6291 in people with advanced RAS G12C-mutated solid tumors, with a specific focus on advanced RAS G12C-mutated NSCLC.[1]
The study is authorised and plans to enroll 267 participants.[1]
Who the study is for
This trial is designed for patients with advanced RAS G12C-mutated solid tumors, and the brief summary also names advanced RAS G12C-mutated NSCLC as a key target group.[1]
NSCLC means non-small cell lung cancer, which is the most common type of lung cancer.[1]
The trial data do not list all entry rules here, but they show that the study is aimed at people whose cancer has the RAS G12C mutation.[1]
What the study is testing
The study is testing Rmc-6291 in combination with pembrolizumab, with or without RMC-6236, and with or without chemotherapy.[1]
The chemotherapy drugs listed in the trial data include pemetrexed, cisplatin, and carboplatin, along with several listed product names for these medicines.[1]
The main goal is to see whether these combinations are safe and tolerable in the target patient groups.[1]
Study phase and size
This is a Phase 1 trial, which means it is an early study that mainly looks at safety and dose selection.[1]
The brief summary says the study aims to define the RP2DS, which means the recommended dose for a phase 2 study.[1]
The planned enrollment is 267 people, which is the number of participants the study aims to include.[1]
What the study measures
The primary outcome includes the incidence of dose-limiting toxicities, which are side effects serious enough to limit further dose increases.[1]
The study also measures treatment-emergent adverse events, treatment-related adverse events, and serious adverse events.[1]
In addition, the trial checks for clinically significant changes in laboratory test values, ECGs, and vital signs.[1]
What the trial means for patients
For patients, this trial is mainly about early testing of Rmc-6291 in cancer combinations, not yet about proving long-term benefit.[1]
Because it is a Phase 1 study, the main focus is on learning how the treatment combinations behave in the body of people with these cancers and whether the doses can be used safely.[1]
The study may help guide later research in advanced RAS G12C-mutated NSCLC and other solid tumors with the same mutation.[1]
