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Expanded Access of Sotorasib

Primary Purpose

Non Small-cell Lung Cancer, Locally Advanced Unresectable NSCLC, Locally Advanced Metastatic NSCLC

Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
AMG 510
Sponsored by
Amgen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Non Small-cell Lung Cancer focused on measuring NSCLC, KRAS p.G12C Mutation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Clearview Cancer Institute
  • Alaska Oncology and Hematology LLC
  • Ironwood Cancer and Research Center
  • Arizona Oncology Associates Professional Corporation
  • San Luis Valley Health Regional Medical Center
  • Kaiser Permanente
  • Sacred Heart Medical Oncology Group
  • Cancer Care Specialists of Central Illinois
  • McFarland Clinic PC
  • Des Moines Oncology Research Association
  • Saint Joseph East
  • Louisiana Hematology Oncology Associates
  • Northern Light Cancer Center
  • University of Pittsburgh Medical Center Western Maryland
  • Maryland Oncology Hematology, PA
  • Dana Farber Cancer Institute
  • Mid Michigan Medical Center
  • Saint Lukes Cancer Institute
  • Oncology Hematology Associates
  • Nebraska Cancer Specialists
  • Englewood Hospital and Medical Center
  • Overlook Medical Center
  • Wake Forest Baptist Comprehensive Cancer Research Center
  • Cleveland Clinic Taussig Cancer Institute
  • LeHigh Valley Hospital
  • Fox Chase Cancer Center
  • Scranton Hematology Oncology
  • Erlanger East Hospital
  • Baptist Cancer Center
  • Saint Marys Medical Center
  • Instituto Médico Especializado Alexander Fleming
  • Hospital Aleman
  • Cemic
  • Clínica Universitaria Privada Reina Fabiola
  • Hospital Sirio Libanes
  • Personal Oncologia de Precisao e Personalizada
  • Instituto de Oncologia do Parana
  • Liga Norte-Riograndense Contra O Cancer
  • YNOVA Pesquisa Clinica
  • Fundacao Pio 12 Hospital de Cancer de Barretos
  • Oncoclinicas Rio de Janeiro S A
  • Meir Medical Center
  • Shaare Zedek Medical Center
  • Rabin Medical Center
  • King Fahad Specialist Hospital
  • King Abdulaziz Medical City - National Guard Hospital
  • King Saud University Medical City-King Khalid University Hospital
  • King Faisal Specialist Hospital
  • Kaohsiung Chang Gung Memorial Hospital
  • Chung Shan Medical University Hospital
  • Veterans General Hospital - Taichung
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Linkou Chang Gung Memorial Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 8, 2020
Last Updated
September 27, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04667234
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small-cell Lung Cancer, Locally Advanced Unresectable NSCLC, Locally Advanced Metastatic NSCLC
Keywords
NSCLC, KRAS p.G12C Mutation

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AMG 510
Other Intervention Name(s)
Sotorasib, Lumakras (US), Lumykras (UK)
Intervention Description
Administered as an oral tablet.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Clearview Cancer Institute
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
Alaska Oncology and Hematology LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Ironwood Cancer and Research Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Arizona Oncology Associates Professional Corporation
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
San Luis Valley Health Regional Medical Center
City
Alamosa
State/Province
Colorado
ZIP/Postal Code
81101
Country
United States
Facility Name
Kaiser Permanente
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Sacred Heart Medical Oncology Group
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Cancer Care Specialists of Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
McFarland Clinic PC
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Des Moines Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Saint Joseph East
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Louisiana Hematology Oncology Associates
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Northern Light Cancer Center
City
Brewer
State/Province
Maine
ZIP/Postal Code
04412
Country
United States
Facility Name
University of Pittsburgh Medical Center Western Maryland
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Maryland Oncology Hematology, PA
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mid Michigan Medical Center
City
Midland
State/Province
Michigan
ZIP/Postal Code
48640
Country
United States
Facility Name
Saint Lukes Cancer Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Oncology Hematology Associates
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Overlook Medical Center
City
Summit
State/Province
New Jersey
ZIP/Postal Code
91010
Country
United States
Facility Name
Wake Forest Baptist Comprehensive Cancer Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
LeHigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Scranton Hematology Oncology
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States
Facility Name
Erlanger East Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Baptist Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Saint Marys Medical Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25705
Country
United States
Facility Name
Instituto Médico Especializado Alexander Fleming
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Hospital Aleman
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Cemic
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Clínica Universitaria Privada Reina Fabiola
City
Córdoba
ZIP/Postal Code
X5004FHP
Country
Argentina
Facility Name
Hospital Sirio Libanes
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70200-730
Country
Brazil
Facility Name
Personal Oncologia de Precisao e Personalizada
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-090
Country
Brazil
Facility Name
Instituto de Oncologia do Parana
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80040-170
Country
Brazil
Facility Name
Liga Norte-Riograndense Contra O Cancer
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
YNOVA Pesquisa Clinica
City
Florianopolis
State/Province
Santa Catarina
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Fundacao Pio 12 Hospital de Cancer de Barretos
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Oncoclinicas Rio de Janeiro S A
City
Rio De Janeiro/RJ
ZIP/Postal Code
22250-905
Country
Brazil
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
King Fahad Specialist Hospital
City
Dammam
ZIP/Postal Code
32253
Country
Saudi Arabia
Facility Name
King Abdulaziz Medical City - National Guard Hospital
City
Riyadh
ZIP/Postal Code
11426
Country
Saudi Arabia
Facility Name
King Saud University Medical City-King Khalid University Hospital
City
Riyadh
ZIP/Postal Code
12372
Country
Saudi Arabia
Facility Name
King Faisal Specialist Hospital
City
Riyadh
ZIP/Postal Code
12713
Country
Saudi Arabia
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
Veterans General Hospital - Taichung
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Expanded Access of Sotorasib

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