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Avutometinib + Sotorasib for Lung Cancer (RAMP203 Trial)
RAMP203 Trial Summary
This trial will study the safety and effectiveness of VS-6766 when used with sotorasib in patients with a specific type of lung cancer.
RAMP203 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RAMP203 Trial Design
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Who is running the clinical trial?
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- My cancer has a KRAS G12C mutation.I haven't had any cancer treatments in the last 4 weeks.I've had 1-2 treatments for advanced lung cancer.I've needed treatment for a skin condition in the last year.I haven't taken strong CYP3A4 affecting drugs in the last 14 days.I am 18 years old or older.I cannot swallow pills.I have been treated with a MEK inhibitor before.I had cancer before, but it was treated and considered cured.I am not pregnant or breastfeeding.I have not had major surgery in the last 4 weeks or minor surgery in the last 2 weeks.I have received at least one dose of a G12C inhibitor.I have had COVID-19 within the last 28 days.My lung cancer diagnosis was confirmed by lab tests.I am fully active or have some restrictions but can still care for myself.I have had rhabdomyolysis in the past.I have an eye condition.My organs are working well.I need medication or treatment for brain cancer symptoms.I have heart disease or severe lung problems.I have recovered from side effects of my previous cancer treatments.I have an active hepatitis B, C, or HIV infection.I have not taken a KRAS inhibitor for my condition.I was treated with sotorasib but had to lower the dose because of side effects.
- Group 1: avutometinib (VS-6766)+sotorasib - KRAS G12C inhibitor naïve
- Group 2: avutometinib (VS-6766)+sotorasib+defactinib - KRAS G12C inhibitor naive
- Group 3: avutometinib (VS-6766)+sotorasib
- Group 4: avutometinib (VS-6766)+sotorasib - KRAS G12C inhibitor exposed
- Group 5: avutometinib (VS-6766)+sotorasib+defactinib
- Group 6: avutometinib (VS-6766)+sotorasib+defactinib - KRAS G12C inhibitor exposed
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is enrollment still open for this medical trial?
"Yes, the details on clinicaltrials.gov make clear that this medical trial is currently recruiting participants. This investigation was first published April 12th 2022 and has since been updated August 3rd of the same year. The researchers are aiming to recruit 53 individuals from 4 different locations."
What medical applications are most commonly associated with VS-6766 and sotorasib?
"VS-6766 and sotorasib are often used to treat those who have undergone prior platinum based therapy, as well as for a range of other malignancies. Additionally, this duo can be prescribed for specific therapeutic procedures and one previous systemic treatment."
What past research has been conducted around the usage of VS-6766 and sotorasib?
"Currently, 11 medical trials exploring the efficacy of VS-6766 and sotorasib are in progress with 1 study reaching Phase 3. 1376 clinical trial sites have been identified for these two drugs, though most are located within Sutton, Cataluña."
Is this research initiative a pioneering endeavor?
"As of now, 11 active studies concerning VS-6766 and sotorasib are being conducted in 632 cities spread out across 28 countries. The first trial for these drugs was sponsored by Amgen in 2018, involving 713 patients who successfully passed the Phase 1 & 2 trials stages. Since then, 3 additional studies have been completed."
Are there a multitude of facilities currently conducting this experiment within the state?
"Enrolment for this trial is occurring at 4 distinct medical centres, including locations in Boston, Saint Louis and Fairfax. It would be advisable to opt for the centre closest to you if you decide to participate in order to minimize travel commitments."
What are the desired outcomes of this experiment?
"The principal assessment metric of this trial, which spans 16 weeks from the start to confirmation of response is determining RP2D for VS-6766 in combination with sotorasib. Additional metrics include Disease Control Rate (DCR), Plasma Pharmacokinetics (PK) including Tmax and Progression Free Survival (PFS)."
How many participants are partaking in this clinical trial at its full capacity?
"Affirmative, clinicaltrials.gov exhibits that this experiment is actively enrolling volunteers. It was initially posted on April 12th 2022 and the last update occurred August 3rd of the same year. This trial has 53 slots at four hospitals expecting to be filled."
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