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A Study of Avutometinib (VS-6766) + Defactinib in Recurrent KRAS G12V, Other KRAS and BRAF Non-Small Cell Lung Cancer (RAMP202)

Primary Purpose

Non Small Cell Lung Cancer, KRAS Activating Mutation

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
avutometinib (VS-6766)
avutometinib (VS-6766) and Defactinib
Sponsored by
Verastem, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring NSCLC, KRAS-G12V, G12V, BRAF, V600E, KRAS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects ≥ 18 years of age
  • Histologic or cytologic evidence of NSCLC
  • Known KRAS or BRAF mutation
  • The subject must have received appropriate prior therapy
  • Measurable disease according to RECIST 1.1
  • An Eastern Cooperative Group (ECOG) performance status ≤ 1
  • Adequate organ function
  • Adequate recovery from toxicities related to prior treatments
  • Agreement to use highly effective method of contraceptive

Exclusion Criteria:

  • Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy
  • History of prior malignancy, with the exception of curatively treated malignancies
  • Major surgery within 4 weeks (excluding placement of vascular access)
  • History of treatment with a direct and specific inhibitor of MEK, KRAS or BRAF except for treatment of BRAF V-600E mutant NSCLC
  • Exposure to strong CYP2C9 and CYP3A4 inhibitors or inducers within 7 days prior to the first dose and during the course of therapy
  • Symptomatic brain metastases requiring steroids or other local interventions.
  • Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy
  • Active skin disorder that has required systemic therapy within the past 1 year
  • History of rhabdomyolysis
  • Concurrent ocular disorders
  • Concurrent heart disease or severe obstructive pulmonary disease
  • Subjects with the inability to swallow oral medications

Sites / Locations

  • City of HopeRecruiting
  • University of Colorado HospitalRecruiting
  • Rocky Mountain Cancer CentersRecruiting
  • Georgetown University Medical CenterRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Emory University School of MedicineRecruiting
  • Northwestern UniversityRecruiting
  • University of Chicago Medical Center-Duchossois Center for Advanced MedicineRecruiting
  • Illinois Cancer SpecialistsRecruiting
  • Hematology/Oncology Clinic, LLPRecruiting
  • Maryland Oncology Hematology P.ARecruiting
  • Dana Farber Cancer InstituteRecruiting
  • Henry Ford Cancer Institute/Henry Ford Health SystemRecruiting
  • Washington University School of MedicineRecruiting
  • Hackensack University Medical CenterRecruiting
  • Northwell Health-Monter Cancer CenterRecruiting
  • Zangmeister Cancer CenterRecruiting
  • Northwest Cancer Specialists, P.C.Recruiting
  • Fox Chase Cancer CenterRecruiting
  • Univ. of Pittsburgh Med CenterRecruiting
  • Chattanooga Oncology Hematology Assoc.Recruiting
  • Tennessee OncologyRecruiting
  • Texas OncologyRecruiting
  • Texas Oncology Ft Worth Cancer CenterRecruiting
  • Texas OncologyRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Virginia Cancer Specialists, PCRecruiting
  • Centre Leon BerardRecruiting
  • Hopital Nord MarseilleRecruiting
  • Hopital CochinRecruiting
  • Institute De Cancerologie De L'Ouest Site Paul Papin Oncologie MedicaleRecruiting
  • Cancerologie Gustave Roussy - Cancer MedicineRecruiting
  • Klinikum Chemnitz gGmbHRecruiting
  • Universitatsklinkum LeipzigRecruiting
  • Evangelisches Klinkum BethelRecruiting
  • Azienda Ospedaliera UniversitariaRecruiting
  • Irccs, IrtsRecruiting
  • UOC di Oncologia MedicaRecruiting
  • Centro Ricerche Cliniche di VeronaRecruiting
  • Hospital Clinic de BarcelonaRecruiting
  • Complejo Hospitalario Universiario a Coruna TeresaRecruiting
  • Hospital 12 de OctubreRecruiting
  • Universitario de TeatinosRecruiting
  • Hospital Universitario Virgen de la MacarenaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

in patients with NSCLC KRAS-G12V tumor

in patients with a NSCLC KRAS-G12V tumor

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

in patients with a NSCLC BRAF-V600E tumor

in patients with a NSCLC BRAF-non-V600E tumor

Outcomes

Primary Outcome Measures

To determine the optimal regimen, either avutometinib (VS-6766) monotherapy or avutometinib (VS-6766) in combination with defactinib, in KRAS-G12V NSCLC
Confirmed overall response rate per RECIST 1.1
To evaluate the initial efficacy of avutometinib (VS-6766) in combination with defactinib in BRAF-MT NSCLC
Confirmed overall response rate per RECIST 1.1
To determine efficacy in KRAS-other (non-G12V) NSCLC
Confirmed overall response rate per RECIST 1.1
To determine the efficacy of avutometinib (VS-6766) in combination with defactinib in BRAF-MT NSCLC
Confirmed overall response rate per RECIST 1.1

Secondary Outcome Measures

To characterize the safety and toxicity profile of VS-6766 as a monotherapy and in combination with defactinib in KRAS-MT NSCLC and in BRAF-MT NSCLC
Adverse events (AEs), serious AEs (SAEs), vital signs, physical examinations, clinical laboratory values, and tolerability (dose interruptions/reductions)
Overall Response Rate per RECIST 1.1 as assessed by Investigator
Proportioned subjects achieving a CR or PR as assess by the investigator
Duration of Response (DOR)
Time of first response to PD as assessed by the IRC
Disease Control Rate (DCR)
CR and PR stable disease as assessed by the IRC
Progression Free Survival (PFS)
From the time of first dose of study intervention to PD or death from any cause
Overall Survival (OS)
From time of first dose of study intervention to death

Full Information

First Posted
November 5, 2020
Last Updated
December 22, 2022
Sponsor
Verastem, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04620330
Brief Title
A Study of Avutometinib (VS-6766) + Defactinib in Recurrent KRAS G12V, Other KRAS and BRAF Non-Small Cell Lung Cancer
Acronym
RAMP202
Official Title
A Phase 2 Study of Avutometinib (VS-6766) (Dual RAF/MEK Inhibitor) as a Single Agent and In Combination With Defactinib (FAK Inhibitor) in Recurrent KRAS-Mutant (KRAS-MT) and BRAF-Mutant (BRAF-MT) Non-Small Cell Lung Cancer (NSCLC) (RAMP 202)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 31, 2020 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Verastem, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy or VS-6766 in combination with defactinib in subjects with recurrent Non-small cell lung cancer.
Detailed Description
This is a multicenter, open-label Phase 2 study designed to evaluate safety and tolerability and efficacy of avutometinib (VS-6766) versus avutometinib (VS-6766) in combination with defactinib in subjects with KRAS and BRAF mutant NSCLC following treatment with an appropriate platinum-based regimen and an approved immune checkpoint inhibitor (CPI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, KRAS Activating Mutation
Keywords
NSCLC, KRAS-G12V, G12V, BRAF, V600E, KRAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: avutometinib (VS-6766) monotherapy
Arm Type
Experimental
Arm Description
in patients with NSCLC KRAS-G12V tumor
Arm Title
Arm 2: avutometinib (VS-6766) in combination with defactinib
Arm Type
Experimental
Arm Description
in patients with a NSCLC KRAS-G12V tumor
Arm Title
Arm 3: avutometinib (VS-6766) in combination with defactinib
Arm Type
Experimental
Arm Description
in patients with a NSCLC KRAS-other (non-G12V) tumor
Arm Title
Arm 4: avutometinib (VS-6766) in combination with defactinib
Arm Type
Experimental
Arm Description
in patients with a NSCLC BRAF-V600E tumor
Arm Title
Arm 5:avutometinib (VS-6766) in combination with defactinib
Arm Type
Experimental
Arm Description
in patients with a NSCLC BRAF-non-V600E tumor
Intervention Type
Drug
Intervention Name(s)
avutometinib (VS-6766)
Intervention Description
Monotherapy
Intervention Type
Drug
Intervention Name(s)
avutometinib (VS-6766) and Defactinib
Other Intervention Name(s)
avutometinib (VS-6766) and VS-6063
Intervention Description
Combination therapy
Primary Outcome Measure Information:
Title
To determine the optimal regimen, either avutometinib (VS-6766) monotherapy or avutometinib (VS-6766) in combination with defactinib, in KRAS-G12V NSCLC
Description
Confirmed overall response rate per RECIST 1.1
Time Frame
From start of treatment to confirmation of response; 24 weeks
Title
To evaluate the initial efficacy of avutometinib (VS-6766) in combination with defactinib in BRAF-MT NSCLC
Description
Confirmed overall response rate per RECIST 1.1
Time Frame
From start of treatment to confirmation of response; 24 weeks
Title
To determine efficacy in KRAS-other (non-G12V) NSCLC
Description
Confirmed overall response rate per RECIST 1.1
Time Frame
From start of treatment to confirmation of response; 24 weeks
Title
To determine the efficacy of avutometinib (VS-6766) in combination with defactinib in BRAF-MT NSCLC
Description
Confirmed overall response rate per RECIST 1.1
Time Frame
From start of treatment to confirmation of response; 24 weeks
Secondary Outcome Measure Information:
Title
To characterize the safety and toxicity profile of VS-6766 as a monotherapy and in combination with defactinib in KRAS-MT NSCLC and in BRAF-MT NSCLC
Description
Adverse events (AEs), serious AEs (SAEs), vital signs, physical examinations, clinical laboratory values, and tolerability (dose interruptions/reductions)
Time Frame
24 weeks
Title
Overall Response Rate per RECIST 1.1 as assessed by Investigator
Description
Proportioned subjects achieving a CR or PR as assess by the investigator
Time Frame
From start of treatment to confirmation of response; 24 weeks
Title
Duration of Response (DOR)
Description
Time of first response to PD as assessed by the IRC
Time Frame
Time from the first documentation of response to first documentation of progressive disease or death due to any cause, greater than or equal to 6 months
Title
Disease Control Rate (DCR)
Description
CR and PR stable disease as assessed by the IRC
Time Frame
Greater than or equal to 8 weeks
Title
Progression Free Survival (PFS)
Description
From the time of first dose of study intervention to PD or death from any cause
Time Frame
Up to 5 years
Title
Overall Survival (OS)
Description
From time of first dose of study intervention to death
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects ≥ 18 years of age Histologic or cytologic evidence of NSCLC Known KRAS or BRAF mutation The subject must have received appropriate prior therapy Measurable disease according to RECIST 1.1 An Eastern Cooperative Group (ECOG) performance status ≤ 1 Adequate organ function Adequate recovery from toxicities related to prior treatments Agreement to use highly effective method of contraceptive Exclusion Criteria: Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy History of prior malignancy, with the exception of curatively treated malignancies Major surgery within 4 weeks (excluding placement of vascular access) History of treatment with a direct and specific inhibitor of MEK, KRAS or BRAF except for treatment of BRAF V-600E mutant NSCLC Exposure to strong CYP2C9 and CYP3A4 inhibitors or inducers within 7 days prior to the first dose and during the course of therapy Symptomatic brain metastases requiring steroids or other local interventions. Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy Active skin disorder that has required systemic therapy within the past 1 year History of rhabdomyolysis Concurrent ocular disorders Concurrent heart disease or severe obstructive pulmonary disease Subjects with the inability to swallow oral medications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Verastem Call Center
Phone
781-292-4204
Email
clinicaltrials@verastem.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross Camidge, MD, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MD Verastem
Organizational Affiliation
Verastem, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ravi Salgia
Phone
626-218-8900
Email
rsalgia@coh.org
First Name & Middle Initial & Last Name & Degree
Ravi Salgia, MD
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cole Sprague
Phone
720-848-8030
Email
COLE.SPRAGUE@CUANSCHUTZ.EDU
First Name & Middle Initial & Last Name & Degree
Ross Camidge, MD
Facility Name
Rocky Mountain Cancer Centers
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Hedge
Phone
303-385-2067
Email
Jennifer.Hege@usoncology.com
First Name & Middle Initial & Last Name & Degree
Robert M Jotte, MD
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Reuss
Email
Joshua.E.Reuss@gunet.georgetown.edu
First Name & Middle Initial & Last Name & Degree
Joshua Reuss, MD
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Cannon Research Site
Phone
844-482-4812
Email
asksarah@sarahcannon.com
First Name & Middle Initial & Last Name & Degree
Faithlore Gardner, MD
Facility Name
Florida Cancer Specialists
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Cannon Research Site
Phone
844-482-4812
Email
asksarah@sarahcannon.com
First Name & Middle Initial & Last Name & Degree
Sunil Gandhi, MD
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin T Davis
Phone
404-778-1900
Email
erin.t.davis@emory.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Carlisle, MD
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dakota Horstman
Phone
312-695-1301
Email
cancertrials@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Jyoti Patel, MD
Facility Name
University of Chicago Medical Center-Duchossois Center for Advanced Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Intake
Phone
855-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Ardaman Shergill, MD
Facility Name
Illinois Cancer Specialists
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisbeth Lynn
Email
Lisbeth.lynn@usoncology.com
First Name & Middle Initial & Last Name & Degree
David Hakimian, MD
Facility Name
Hematology/Oncology Clinic, LLP
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Cannon Research Site
Phone
844-482-4812
Email
asksarah@sarahcannon.com
First Name & Middle Initial & Last Name & Degree
Michael Castine, MD
Facility Name
Maryland Oncology Hematology P.A
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Missy Almand
Email
MOHRSCH@usoncology.com
First Name & Middle Initial & Last Name & Degree
Yousuf Gaffar, MD
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Farber Cancer Institute
Phone
877-338-7425
First Name & Middle Initial & Last Name & Degree
Janne Pasi, MD
Facility Name
Henry Ford Cancer Institute/Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thoracic Oncology Clinical Research
Email
TOCResearch@hfhs.org
First Name & Middle Initial & Last Name & Degree
Shirish Gadgeel, MD
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saiama Waqar, MD
Phone
314-747-8475
Email
saiamawaqar@wustl.edu
First Name & Middle Initial & Last Name & Degree
Saiama Waqar
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chelsea McCabe
Email
Chelsea.McCabe@hmhn.org
First Name & Middle Initial & Last Name & Degree
Martin Gutierrez, MD
Facility Name
Northwell Health-Monter Cancer Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Sullivan
Phone
516-734-7605
Email
Ksullivan3@northwell.edu
First Name & Middle Initial & Last Name & Degree
Kevin Sullivan, MD
Facility Name
Zangmeister Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Zangmeister
Phone
614-383-6236
Email
Nancy.Zangmeister@aoncology.com
First Name & Middle Initial & Last Name & Degree
Jorge Rios, MD
Facility Name
Northwest Cancer Specialists, P.C.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine Bigler
Email
Margaret.Bigler@USONCOLOGY.COM
First Name & Middle Initial & Last Name & Degree
Robert Lufkin, MD
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Edelman
Email
martin.edelman@fccc.edu
First Name & Middle Initial & Last Name & Degree
Joseph Treat, MD
Facility Name
Univ. of Pittsburgh Med Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jen Ruth
Email
ruthj2@upmc.edu
First Name & Middle Initial & Last Name & Degree
Timothy Burns, MD
Facility Name
Chattanooga Oncology Hematology Assoc.
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
037404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Cannon Research Site
Phone
844-482-4812
Email
asksarah@sarahcannon.com
First Name & Middle Initial & Last Name & Degree
Davey Daniel, MD
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Cannon Research Site
Phone
844-482-4812
Email
asksarah@sarahcannon.com
First Name & Middle Initial & Last Name & Degree
David Spigel, MD
Facility Name
Texas Oncology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Huntzinger
Email
Jonathan.Huntzinger@USONCOLOGY.COM
First Name & Middle Initial & Last Name & Degree
Kartik Konduri, MD
Facility Name
Texas Oncology Ft Worth Cancer Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nori Sullivan
Email
Nori.sullivan@usoncology.com
First Name & Middle Initial & Last Name & Degree
Asad Dean, MD
Facility Name
Texas Oncology
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonya Springer
Email
Sonya.Springer@usoncology.com
First Name & Middle Initial & Last Name & Degree
Heidi Jordan, MD
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Destiny Keaton
Phone
713-792-5122
Email
dkeaton@mdanderson.org
First Name & Middle Initial & Last Name & Degree
George Blumenschien, MD
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcy Sullivan
Email
marcy.sullivan@usoncology.com
First Name & Middle Initial & Last Name & Degree
Alexander Spira, MD
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Porret
Email
martin.porret@lyon.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Maurice Perol, MD
Facility Name
Hopital Nord Marseille
City
Marseille
ZIP/Postal Code
13915
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maryline Blanchon
Email
maryline.blanchon@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Pascale Tomasini
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Mathiot
First Name & Middle Initial & Last Name & Degree
Marie Wislez, MD
Facility Name
Institute De Cancerologie De L'Ouest Site Paul Papin Oncologie Medicale
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle Brisou
Email
emmanuelle.brisou@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Sandine Hiret, MD
Facility Name
Cancerologie Gustave Roussy - Cancer Medicine
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevinee Khoobarry
Email
kevinee.khoobarry@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Fabice Barlesi, MD
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Hammerschmidt
First Name & Middle Initial & Last Name & Degree
Stefan Hammerschmidt, MD
Facility Name
Universitatsklinkum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof Hubert Wirtz
Email
hubert.wirtz@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Prof Hubert Wirtz, MD
Facility Name
Evangelisches Klinkum Bethel
City
Straße
ZIP/Postal Code
33611
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Weißinger
Phone
0049 521 773 75750
First Name & Middle Initial & Last Name & Degree
Florian Weißinger
Facility Name
Azienda Ospedaliera Universitaria
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Novello
Phone
39 0119026978
Email
silvia.novello@unito.it
First Name & Middle Initial & Last Name & Degree
Silvia Novello, MD
Facility Name
Irccs, Irts
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelo Delmonte
Email
angelo.delmonte@irst.emr.it
First Name & Middle Initial & Last Name & Degree
Angelo Delmonte
Facility Name
UOC di Oncologia Medica
City
Parma
ZIP/Postal Code
43126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcello Tiseo
Email
mtiseo@ao.pr.it
First Name & Middle Initial & Last Name & Degree
Marcello Tiseo
Facility Name
Centro Ricerche Cliniche di Verona
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Milella
Phone
+39 0543739100
Email
michele.milella@univr.it
First Name & Middle Initial & Last Name & Degree
Michele Milella
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noemi Reguart Aransay
Phone
+34 93 227 54 02
Email
nreguart@clinic.cat
First Name & Middle Initial & Last Name & Degree
Noemi Reguart Aransay
Facility Name
Complejo Hospitalario Universiario a Coruna Teresa
City
Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Garcia Campelo
Phone
34 98 11 78000
First Name & Middle Initial & Last Name & Degree
Maria Garcia Campelo
Facility Name
Hospital 12 de Octubre
City
Córdoba
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Gonzaga Paz-Ares Rodriguez
Email
Lpazaresr@Seom.Org
First Name & Middle Initial & Last Name & Degree
Luis Gonzaga Paz-Ares Rodriguez
Facility Name
Universitario de Teatinos
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Immaculada Ramos
Phone
+34 95 1032508
Email
ramosgarcia22@gmail.com
First Name & Middle Initial & Last Name & Degree
Immaculada Ramos, MD
Facility Name
Hospital Universitario Virgen de la Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Vicente Baz
Phone
34 955 00 80 00
First Name & Middle Initial & Last Name & Degree
David Vicente Baz, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35285277
Citation
Capelletto E, Bironzo P, Denis L, Koustenis A, Bungaro M, Novello S. Single agent VS-6766 or VS-6766 plus defactinib in KRAS-mutant non-small-cell lung cancer: the RAMP-202 phase II trial. Future Oncol. 2022 May;18(16):1907-1915. doi: 10.2217/fon-2021-1582. Epub 2022 Mar 14.
Results Reference
derived

Learn more about this trial

A Study of Avutometinib (VS-6766) + Defactinib in Recurrent KRAS G12V, Other KRAS and BRAF Non-Small Cell Lung Cancer

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