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NCT04667234 Clinical Trial

Expanded Access of Sotorasib

Non Small-cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT04667234
Other study ID # 20190436
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date September 2023
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AMG 510
Administered as an oral tablet.

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

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Israel,  Saudi Arabia,  Taiwan, 

See also
  Status Clinical Trial Phase
Completed NCT01652820 - Chemotherapy/Radiotherapy Versus Concomitant Chemotherapy Followed by Radiotherapy in Stage IIIB Non-small Cell Lung Cancer Phase 2
Completed NCT01402089 - Cytochrom p450 3A4 and 1A2 Phenotyping for the Individualization of Treatment With Sunitinib or Erlotinib in Cancer Patients Phase 4
Completed NCT01257139 - Trial Involving Subjects Over 70 Years of Age With Non Small-cell Lung Cancer of Stage IV and Comparing a "Classical" Strategy of Treatment Allocation, With an"Optimized" Strategy Allocating the Same Treatments Phase 3
Completed NCT01662635 - Clinicopathological Features of NSCLC Patients Associated With the Chromosome 2p (EML4-ALK)
Active, not recruiting NCT05462795 - Liquid Biopsy for Early Non-small Lung Cancer Detection

External Links