Avutometinib + Sotorasib for Lung Cancer
(RAMP203 Trial)
Trial Summary
What is the purpose of this trial?
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with sotorasib with or without defactinib in patients with KRAS G12C Non-Small Cell Lung Cancer (NSCLC) in patients who have been exposed to prior G12C inhibitor and those who have not been exposed to prior G12C inhibitor.
Will I have to stop taking my current medications?
The trial requires that you stop taking any strong CYP3A4 inhibitors or inducers (types of drugs that affect how your body processes medications) at least 14 days before starting the study and during the trial. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug Avutometinib + Sotorasib for lung cancer?
Sotorasib has been shown to be effective for treating non-small cell lung cancer (NSCLC) with a specific KRAS mutation, with a 36% response rate in patients who had already tried other treatments. This suggests that sotorasib, as part of the combination with Avutometinib, may offer benefits for similar lung cancer cases.12345
Is the combination of Avutometinib and Sotorasib safe for humans?
Sotorasib, also known as Lumakras, has been approved for treating certain lung cancers and is generally considered safe, though common side effects include diarrhea, muscle pain, nausea, fatigue, liver issues, and cough. There is no specific safety data available for the combination of Avutometinib and Sotorasib, but Sotorasib alone has a manageable safety profile.12367
What makes the drug Avutometinib + Sotorasib unique for lung cancer?
The combination of Avutometinib and Sotorasib is unique because it targets KRAS G12C mutations in non-small cell lung cancer (NSCLC), with Sotorasib being the first approved drug specifically for this mutation. This combination may offer a new option for patients who have already undergone other treatments.12348
Research Team
MD Verastem
Principal Investigator
Verastem, Inc.
Eligibility Criteria
This trial is for adults with a specific mutation in their lung cancer (G12C KRAS). They must have tried some treatments but not more than two, and can't have used a KRAS inhibitor if they want to join certain parts of the study. Participants need good organ function, no recent other cancers or severe illnesses, and agree to use birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive avutometinib (VS-6766) in combination with sotorasib with or without defactinib to determine the recommended phase 2 dose (RP2D) and assess efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- Avutometinib (VS-6766)
- Sotorasib
Avutometinib (VS-6766) is already approved in United States for the following indications:
- Recurrent low-grade serous ovarian cancer (Breakthrough Therapy Designation)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Verastem, Inc.
Lead Sponsor
Amgen
Industry Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London