Osimertinib

Generic Name
Osimertinib
Brand Names
Tagrisso
Drug Type
Small Molecule
Chemical Formula
C28H33N7O2
CAS Number
1421373-65-0
Unique Ingredient Identifier
3C06JJ0Z2O
Background

Osimertinib is an oral, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) drug developed by AstraZeneca Pharmaceuticals. Its use is indicated for the treatment of metastatic non-small cell lung cancer (NSCLC) in cases where tumour EGFR expression is positive for the T790M mutation as detected by FDA-approved testing and...

Indication

Osimertinib is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations (as detected by an FDA-approved test), and as the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGF...

Associated Conditions
Metastatic Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma
Associated Therapies
First Line Chemotherapy

A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2019-05-07
Last Posted Date
2024-12-11
Lead Sponsor
EMD Serono Research & Development Institute, Inc.
Target Recruit Count
140
Registration Number
NCT03940703
Locations
🇺🇸

Community Health Network, Indianapolis, Indiana, United States

🇺🇸

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States

🇨🇳

The First Affiliated Hospital, Zhejiang University, Hangzhou, China

and more 176 locations

Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

First Posted Date
2019-04-10
Last Posted Date
2024-10-30
Lead Sponsor
Xiuning Le
Target Recruit Count
160
Registration Number
NCT03909334
Locations
🇺🇸

Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States

🇺🇸

Rush University Medical Center, Chicago, Illinois, United States

🇺🇸

Indiana Univesity Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

and more 9 locations

Niraparib in Combination With Osimertinib in EGFR-Mutated Advanced Lung Cancer

Phase 1
Conditions
Interventions
First Posted Date
2019-03-27
Last Posted Date
2020-12-16
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
30
Registration Number
NCT03891615
Locations
🇺🇸

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Osimertinib Study in Indian Patients

Phase 4
Completed
Conditions
Interventions
First Posted Date
2019-02-25
Last Posted Date
2021-06-03
Lead Sponsor
AstraZeneca
Target Recruit Count
60
Registration Number
NCT03853551
Locations
🇮🇳

Research Site, New Delhi, India

Telaglenastat Hydrochloride and Osimertinib in Treating Patients With EGFR-Mutated Stage IV Non-small Cell Lung Cancer

First Posted Date
2019-02-06
Last Posted Date
2024-11-11
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
28
Registration Number
NCT03831932
Locations
🇺🇸

UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States

🇺🇸

University of Virginia Cancer Center, Charlottesville, Virginia, United States

🇺🇸

University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States

and more 8 locations

Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2019-01-22
Last Posted Date
2024-02-02
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
22
Registration Number
NCT03810807
Locations
🇺🇸

Memorial Sloan Kettering Westchester, Harrison, New York, United States

🇺🇸

Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

and more 4 locations

Exploring the Theragnostic Value of Osimertinib in EGFR-mutated Lung Cancer (THEROS)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2019-01-18
Last Posted Date
2024-05-09
Lead Sponsor
University Hospital, Essen
Target Recruit Count
16
Registration Number
NCT03810066
Locations
🇩🇪

Prof. Dr. med. Martin Schuler, Essen, NRW, Germany

First-line Treatment With Osimertinib in EGFR-mutated Non-small Cell Lung Cancer

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2019-01-15
Last Posted Date
2024-05-07
Lead Sponsor
Vestre Viken Hospital Trust
Target Recruit Count
100
Registration Number
NCT03804580
Locations
🇳🇴

Oslo University Hospital - Ullevaal, Oslo, Norway

🇩🇰

Herlev Hospital, Copenhagen, Denmark

🇩🇰

Aarhus University Hospital, Aarhus, Denmark

and more 7 locations

Osimertinib in Subjects With Advanced Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive

Completed
Conditions
First Posted Date
2018-12-31
Last Posted Date
2022-06-03
Lead Sponsor
Fundación GECP
Target Recruit Count
169
Registration Number
NCT03790397
Locations
🇪🇸

Hospital Universitario Dr. Negrín, Las Palmas De Gran Canaria, Las Palmas, Spain

🇪🇸

Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain

🇪🇸

ICO Badalona, Badalona, Barcelona, Spain

and more 28 locations
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