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Kinase Inhibitor

Avutometinib + Defactinib for Non-Small Cell Lung Cancer (RAMP202 Trial)

Phase 2

Waitlist Available

Led By Ross Camidge, MD, PhD

Research Sponsored by Verastem, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

RAMP202 Trial Summary

This trial will study whether a new drug is safe and effective for treating Non-small cell lung cancer that has come back.

Who is the study for?

This trial is for adults with recurrent Non-small cell lung cancer (NSCLC) who have had prior treatments, measurable disease, and known KRAS or BRAF mutations. They must be in good physical condition (ECOG ≤ 1), able to use contraception, and have recovered from previous treatment side effects. People with severe heart or lung conditions, recent strong drug interactions, symptomatic brain metastases, certain ocular disorders or infections are excluded.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of avutometinib alone or combined with defactinib in treating NSCLC. It aims to see how well these drugs work on patients who've seen their cancer return and carry specific genetic changes (KRAS G12V mutation among others).See study design

What are the potential side effects?

Potential side effects may include typical reactions to cancer medications such as nausea, fatigue, skin issues, muscle problems like rhabdomyolysis (muscle breakdown), liver function changes due to organ inflammation but specifics will depend on individual patient responses.

RAMP202 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To determine efficacy in KRAS-other (non-G12V) NSCLC

To determine the efficacy of avutometinib (VS-6766) in combination with defactinib in BRAF-MT NSCLC

To determine the optimal regimen, either avutometinib (VS-6766) monotherapy or avutometinib (VS-6766) in combination with defactinib, in KRAS-G12V NSCLC

+1 more

Secondary outcome measures

Disease Control Rate (DCR)

Duration of Response (DOR)

Overall Response Rate per RECIST 1.1 as assessed by Investigator

+3 more

RAMP202 Trial Design

5Treatment groups

Experimental Treatment

Group I: Arm 5:avutometinib (VS-6766) in combination with defactinibExperimental Treatment1 Intervention

in patients with a NSCLC BRAF-non-V600E tumor

Group II: Arm 4: avutometinib (VS-6766) in combination with defactinibExperimental Treatment1 Intervention

in patients with a NSCLC BRAF-V600E tumor

Group III: Arm 3: avutometinib (VS-6766) in combination with defactinibExperimental Treatment1 Intervention

in patients with a NSCLC KRAS-other (non-G12V) tumor

Group IV: Arm 2: avutometinib (VS-6766) in combination with defactinibExperimental Treatment1 Intervention

in patients with a NSCLC KRAS-G12V tumor

Group V: Arm 1: avutometinib (VS-6766) monotherapyExperimental Treatment1 Intervention

in patients with NSCLC KRAS-G12V tumor

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

avutometinib (VS-6766)

2020

Completed Phase 2

~90

avutometinib (VS-6766) and Defactinib

2020

Completed Phase 2

~90

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Verastem, Inc.Lead Sponsor

38 Previous Clinical Trials

2,508 Total Patients Enrolled

Hagop Youssoufian, MDStudy DirectorVerastem, Inc.

24 Previous Clinical Trials

1,657 Total Patients Enrolled

MD VerastemStudy DirectorVerastem, Inc.

5 Previous Clinical Trials

773 Total Patients Enrolled

Media Library

Avutometinib (VS-6766) (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04620330 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Arm 1: avutometinib (VS-6766) monotherapy, Arm 2: avutometinib (VS-6766) in combination with defactinib, Arm 3: avutometinib (VS-6766) in combination with defactinib, Arm 4: avutometinib (VS-6766) in combination with defactinib, Arm 5:avutometinib (VS-6766) in combination with defactinib

Non-Small Cell Lung Cancer Clinical Trial 2023: Avutometinib (VS-6766) Highlights & Side Effects. Trial Name: NCT04620330 — Phase 2

Avutometinib (VS-6766) (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04620330 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what areas has this trial been implemented?

"As of now, the trial is recruiting from 30 different sites located across America. Notable cities include Saint Louis, Chattanooga and Hackensack among others. It would be wise to select a location closest you so as to reduce travel commitments for participants."

Answered by AI

What is the total participant count for this research endeavor?

"This research, funded by Verastem Inc., requires 100 qualified individuals. It will be conducted at Washington University School of Medicine in Saint Louis and Chattanooga Oncology Hematology Assoc. in Chattanooga, New jersey."

Answered by AI

What primary goals are researchers attempting to achieve through this clinical investigation?

"This clinical trial has two main objectives. The primary goal is to measure efficacy over a 24-week period, while the secondary outcomes evaluate Overall Response Rate (ORR), Duration of Response (DOR) and Progression Free Survival (PFS). These metrics are assessed by investigator assessments such as Complete/Partial Remission or Disease Progression."

Answered by AI

Is recruitment for this research endeavor still being accepted?

"Indeed, the clinicaltrials.gov portal shows that this trial is presently recruiting patients - it was initially posted on December 31st 2020 and last updated July 19th 2022. The study requires 100 participants to be recruited from 30 different sites."

Answered by AI

Are there any published accounts of VS-6766 being used in prior experiments?

"VS-6766 was initially examined by the ECOG-ACRIN Cancer Research Group in 2015. Presently, there are 9 active research projects and 7 completed trials that have been conducted regarding this medication – many of which occur within Saint Louis, Missouri."

Answered by AI

What have been the reported safety outcomes of VS-6766 usage?

"Our team at Power evaluated the safety of VS-6766 to be a 2 due to its Phase 2 status. This indicates that there is some evidence backing the drug's security, but none confirming effectiveness."

Answered by AI