Clinical trial NCT04667234: Expanded Access of Sotorasib
Official title: A Multicenter, Open-label, Single-arm, Expanded Access Protocol of Sotorasib for the Treatment of Subjects With Previously Treated Locally Advanced Unresectable/Metastatic NSCLC With KRAS p.G12C Mutation
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Non Small-cell Lung Cancer
Locally Advanced Unresectable NSCLC
Locally Advanced Metastatic NSCLC
Keywords: NSCLC
KRAS p.G12C Mutation
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2020-12-14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT

Brief summary: The primary objective of this study is to provide expanded access to and characterize the safety profile of Sotorasib in participants with previously treated locally advanced/unresectable/metastatic non small-cell lung cancer (NSCLC) with KRAS p.G12C mutation in a real-world setting.


Eligibility criteria: Inclusion Criteria

* Age ≥ 18 years
* Ineligibility for participation in any Amgen-sponsored ongoing clinical study of the investigational product
* Pathologically documented, locally-advanced and unresectable or metastatic Non Small-Cell Lung Cancer (NSCLC) with KRAS p.G12C mutation confirmed through molecular testing
* Exhausted other standard of care options for locally advanced and unresectable or metastatic NSCLC disease including platinum-based combination chemotherapy and programmed cell death protein 1/programmed death-ligand 1 (PD 1/PD-L1) immunotherapy (unless medically contraindicated)
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

Exclusion Criteria

* Mixed small-cell lung cancer or mixed NSCLC histology
* Active brain metastases
* Active hepatitis B or hepatitis C virus
* Current active malignancy other than NSCLC
* Currently or previously enrolled in a prior sotorasib study unless radiographic disease progression confirmed, able to remain on long term follow up of their original protocol and receives medical monitor approval
* Female participants planning to become pregnant while on study through 7 days after the last dose of sotorasib

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clearview Cancer Institute
state: Alabama
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology LLC
state: Alaska
city: Chandler
country: United States
facility: Ironwood Cancer and Research Center
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates Professional Corporation
state: Arizona
city: Alamosa
country: United States
facility: San Luis Valley Health Regional Medical Center
state: Colorado
city: Lone Tree
country: United States
facility: Kaiser Permanente
state: Colorado
city: Pensacola
country: United States
facility: Sacred Heart Medical Oncology Group
state: Florida
city: Decatur
country: United States
facility: Cancer Care Specialists of Central Illinois
state: Illinois
city: Ames
country: United States
facility: McFarland Clinic PC
state: Iowa
city: Des Moines
country: United States
facility: Des Moines Oncology Research Association
state: Iowa
city: Lexington
country: United States
facility: Saint Joseph East
state: Kentucky
city: Baton Rouge
country: United States
facility: Louisiana Hematology Oncology Associates
state: Louisiana
city: Brewer
country: United States
facility: Northern Light Cancer Center
state: Maine
city: Cumberland
country: United States
facility: University of Pittsburgh Medical Center Western Maryland
state: Maryland
city: Rockville
country: United States
facility: Maryland Oncology Hematology, PA
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Midland
country: United States
facility: Mid Michigan Medical Center
state: Michigan
city: Kansas City
country: United States
facility: Saint Lukes Cancer Institute
state: Missouri
city: Springfield
country: United States
facility: Oncology Hematology Associates
state: Missouri
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Summit
country: United States
facility: Overlook Medical Center
state: New Jersey
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Research Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute
state: Ohio
city: Allentown
country: United States
facility: LeHigh Valley Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Scranton
country: United States
facility: Scranton Hematology Oncology
state: Pennsylvania
city: Chattanooga
country: United States
facility: Erlanger East Hospital
state: Tennessee
city: Memphis
country: United States
facility: Baptist Cancer Center
state: Tennessee
city: Huntington
country: United States
facility: Saint Marys Medical Center
state: West Virginia
city: Capital Federal
country: Argentina
facility: Instituto Médico Especializado Alexander Fleming
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Aleman
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Cemic
state: Buenos Aires
city: Córdoba
country: Argentina
facility: Clínica Universitaria Privada Reina Fabiola
city: Brasilia
country: Brazil
facility: Hospital Sirio Libanes
state: Distrito Federal
city: Belo Horizonte
country: Brazil
facility: Personal Oncologia de Precisao e Personalizada
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Instituto de Oncologia do Parana
state: Paraná
city: Natal
country: Brazil
facility: Liga Norte-Riograndense Contra O Cancer
state: Rio Grande Do Norte
city: Florianopolis
country: Brazil
facility: YNOVA Pesquisa Clinica
state: Santa Catarina
city: Barretos
country: Brazil
facility: Fundacao Pio 12 Hospital de Cancer de Barretos
state: São Paulo
city: Rio De Janeiro/RJ
country: Brazil
facility: Oncoclinicas Rio de Janeiro S A
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petach Tikva
country: Israel
facility: Shaare Zedek Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Dammam
country: Saudi Arabia
facility: King Fahad Specialist Hospital
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City - National Guard Hospital
city: Riyadh
country: Saudi Arabia
facility: King Saud University Medical City-King Khalid University Hospital
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Veterans General Hospital - Taichung
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: