Lung Cancer Clinical Trial

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

Summary

This study will assess the safety and efficacy of VS-6766 monotherapy or VS-6766 in combination with defactinib in subjects with recurrent Non-small cell lung cancer.

View Full Description

Full Description

This is a multicenter, open-label Phase 2 study designed to evaluate safety and tolerability and efficacy of VS-6766 versus 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).

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT04620330

Recruitment Status:

Recruiting

Sponsor:

Verastem, Inc.

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There are 39 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States More Info
Ravi Salgia
Contact
626-218-8900
[email protected]
Ravi Salgia, MD
Principal Investigator
University of Colorado Hospital
Aurora Colorado, 80045, United States More Info
Cole Sprague
Contact
720-848-8030
[email protected]
Ross Camidge, MD
Principal Investigator
Rocky Mountain Cancer Centers
Lone Tree Colorado, 80124, United States More Info
Jennifer Hedge
Contact
303-385-2067
[email protected]
Robert M Jotte, MD
Principal Investigator
Georgetown University Medical Center
Washington District of Columbia, 20007, United States More Info
Joshua Reuss
Contact
[email protected]
Joshua Reuss, MD
Principal Investigator
Florida Cancer Specialists
Fort Myers Florida, 33908, United States More Info
Sarah Cannon Research Site
Contact
844-482-4812
[email protected]
Faithlore Gardner, MD
Principal Investigator
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States More Info
Sarah Cannon Research Site
Contact
844-482-4812
[email protected]
Sunil Gandhi, MD
Principal Investigator
Emory University School of Medicine
Atlanta Georgia, 30322, United States More Info
Erin T Davis
Contact
404-778-1900
[email protected]
Jennifer Carlisle, MD
Principal Investigator
Northwestern University
Chicago Illinois, 60611, United States More Info
Dakota Horstman
Contact
312-695-1301
[email protected]
Jyoti Patel, MD
Principal Investigator
University of Chicago Medical Center-Duchossois Center for Advanced Medicine
Chicago Illinois, 60637, United States More Info
Clinical Trials Intake
Contact
855-702-8222
[email protected]
Ardaman Shergill, MD
Principal Investigator
Illinois Cancer Specialists
Niles Illinois, 60714, United States More Info
Lisbeth Lynn
Contact
[email protected]
David Hakimian, MD
Principal Investigator
Hematology/Oncology Clinic, LLP
Baton Rouge Louisiana, 70809, United States More Info
Sarah Cannon Research Site
Contact
844-482-4812
[email protected]
Michael Castine, MD
Principal Investigator
Maryland Oncology Hematology P.A
Columbia Maryland, 21044, United States More Info
Missy Almand
Contact
[email protected]
Yousuf Gaffar, MD
Principal Investigator
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Dana Farber Cancer Institute
Contact
877-338-7425
Janne Pasi, MD
Principal Investigator
Henry Ford Cancer Institute/Henry Ford Health System
Detroit Michigan, 48202, United States More Info
Thoracic Oncology Clinical Research
Contact
[email protected]
Shirish Gadgeel, MD
Principal Investigator
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Saiama Waqar, MD
Contact
314-747-8475
[email protected]
Saiama Waqar
Principal Investigator
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States More Info
Chelsea McCabe
Contact
[email protected]
Martin Gutierrez, MD
Principal Investigator
Northwell Health-Monter Cancer Center
Lake Success New York, 11042, United States More Info
Kevin Sullivan
Contact
516-734-7605
[email protected]
Kevin Sullivan, MD
Principal Investigator
Zangmeister Cancer Center
Columbus Ohio, 43219, United States More Info
Nancy Zangmeister
Contact
614-383-6236
[email protected]
Jorge Rios, MD
Principal Investigator
Northwest Cancer Specialists, P.C.
Portland Oregon, 97213, United States More Info
Elaine Bigler
Contact
[email protected]
Robert Lufkin, MD
Principal Investigator
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States More Info
Martin Edelman
Contact
[email protected]
Joseph Treat, MD
Principal Investigator
Univ. of Pittsburgh Med Center
Pittsburgh Pennsylvania, 15232, United States More Info
Jen Ruth
Contact
[email protected]
Timothy Burns, MD
Principal Investigator
Chattanooga Oncology Hematology Assoc.
Chattanooga Tennessee, 03740, United States More Info
Sarah Cannon Research Site
Contact
844-482-4812
[email protected]
Davey Daniel, MD
Principal Investigator
Tennessee Oncology
Nashville Tennessee, 37203, United States More Info
Sarah Cannon Research Site
Contact
844-482-4812
[email protected]
David Spigel, MD
Principal Investigator
Texas Oncology
Dallas Texas, 75246, United States More Info
Jonathan Huntzinger
Contact
[email protected]
Kartik Konduri, MD
Principal Investigator
Texas Oncology Ft Worth Cancer Center
Fort Worth Texas, 76104, United States More Info
Nori Sullivan
Contact
[email protected]
Asad Dean, MD
Principal Investigator
Texas Oncology
Grapevine Texas, 76051, United States More Info
Sonya Springer
Contact
[email protected]
Heidi Jordan, MD
Principal Investigator
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Destiny Keaton
Contact
713-792-5122
[email protected]
George Blumenschien, MD
Principal Investigator
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States More Info
Marcy Sullivan
Contact
[email protected]
Alexander Spira, MD
Principal Investigator
Centre Leon Berard
Lyon , 69373, France More Info
Martin Porret
Contact
[email protected]
Maurice Perol, MD
Principal Investigator
Hopital Cochin
Paris , 75014, France More Info
Nathalie Mathiot
Contact
Marie Wislez, MD
Principal Investigator
Institute De Cancerologie De L'Ouest Site Paul Papin Oncologie Medicale
Saint-Herblain , 44805, France More Info
Emmanuelle Brisou
Contact
[email protected]
Sandine Hiret, MD
Principal Investigator
Cancerologie Gustave Roussy - Cancer Medicine
Villejuif , 94800, France More Info
Kevinee Khoobarry
Contact
[email protected]
Fabice Barlesi, MD
Principal Investigator
Klinikum Chemnitz gGmbH
Chemnitz , 09116, Germany More Info
Stefan Hammerschmidt
Contact
Stefan Hammerschmidt, MD
Principal Investigator
Universitatsklinkum Leipzig
Leipzig , 04103, Germany More Info
Prof Hubert Wirtz
Contact
[email protected]
Prof Hubert Wirtz, MD
Principal Investigator
Azienda Ospedaliera Universitaria
Orbassano Torino, 10043, Italy More Info
Silvia Novello
Contact
39 0119026978
[email protected]
Silvia Novello, MD
Principal Investigator
Centro Ricerche Cliniche di Verona
Verona , 37134, Italy More Info
Michele Milella
Contact
+39 0543739100
[email protected]
Michele Milella
Principal Investigator
Hospital Clinic de Barcelona
Barcelona , , Spain More Info
Noemi Reguart Aransay
Contact
+34 93 227 54 02
[email protected]
Noemi Reguart Aransay
Principal Investigator
Complejo Hospitalario Universiario a Coruna Teresa
Coruña , 15006, Spain More Info
Maria Garcia Campelo
Contact
34 98 11 78000
Maria Garcia Campelo
Principal Investigator
Universitario de Teatinos
Málaga , 29010, Spain More Info
Immaculada Ramos
Contact
+34 95 1032508
[email protected]
Immaculada Ramos, MD
Principal Investigator
Hospital Universitario Virgen de la Macarena
Sevilla , 41009, Spain More Info
David Vicente Baz
Contact
34 955 00 80 00
David Vicente Baz, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT04620330

Recruitment Status:

Recruiting

Sponsor:


Verastem, Inc.

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