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

Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Participants With Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer, or With Cetuximab in Participants With Metastatic Colorectal Cancer

First Posted Date
2023-07-20
Last Posted Date
2024-12-02
Lead Sponsor
Genentech, Inc.
Target Recruit Count
172
Registration Number
NCT05954871
Locations
🇺🇸

Yale Cancer Center, New Haven, Connecticut, United States

🇺🇸

Christiana Care Health System, Newark, Delaware, United States

🇺🇸

SCRI Oncology Partners, Nashville, Tennessee, United States

and more 9 locations

TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases

First Posted Date
2023-07-17
Last Posted Date
2024-11-21
Lead Sponsor
TYK Medicines, Inc
Target Recruit Count
420
Registration Number
NCT05948813
Locations
🇨🇳

National Cancer Center/Cancer Hospitial,Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing, China

A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

First Posted Date
2023-04-18
Last Posted Date
2024-07-31
Lead Sponsor
Klus Pharma Inc.
Target Recruit Count
278
Registration Number
NCT05816252
Locations
🇦🇺

St Vincent's Hospital - Kinghorn Cancer Centre, Darlinghurst, New South Wales, Australia

🇨🇳

Beijing Cancer Hospital, Beijing, Beijing, China

🇨🇳

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China

and more 63 locations

A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth Factor Receptor Mutations

First Posted Date
2023-04-06
Last Posted Date
2024-11-06
Lead Sponsor
AstraZeneca
Target Recruit Count
80
Registration Number
NCT05801029
Locations
🇹🇭

Research Site, Songkhla, Thailand

A Study of DB-1310 in Advanced/Metastatic Solid Tumors

First Posted Date
2023-03-27
Last Posted Date
2024-02-23
Lead Sponsor
DualityBio Inc.
Target Recruit Count
287
Registration Number
NCT05785741
Locations
🇺🇸

Research Site 111, Atlanta, Georgia, United States

🇺🇸

University of California, Davis Comprehensive Cancer Center, Sacramento, California, United States

🇺🇸

UCLA Hematology/Oncology - Santa Monica, Santa Monica, California, United States

and more 18 locations

Efficacy Study of Osimertinib in Treatment-naïve Patients With EGFR Mutant NSCLC According to TP53 Mutational Status.

Phase 4
Recruiting
Conditions
Interventions
First Posted Date
2023-03-27
Last Posted Date
2023-03-27
Lead Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Target Recruit Count
122
Registration Number
NCT05785208
Locations
🇮🇹

Università degli Studi di Verona, Verona, Italy

🇮🇹

Ospedale San Luigi, Turin, Italy

🇮🇹

IRCCS Istituto Tumori Giovanni Paolo II, Bari, Italy

and more 8 locations

Tipifarnib and Osimertinib in EGFR-mutated Non-Small Cell Lung Cancer

Phase 1
Withdrawn
Conditions
Interventions
First Posted Date
2023-01-20
Last Posted Date
2023-03-06
Lead Sponsor
Kura Oncology, Inc.
Registration Number
NCT05693090
Locations
🇺🇸

The Valley Hospital, Ridgewood, New Jersey, United States

🇺🇸

Providence Medical Group, Santa Rosa, California, United States

Osimertinib Therapy After Resection in High-risk Stage I EGFRm NSCLC (OSTAR)

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2023-01-17
Last Posted Date
2023-01-17
Lead Sponsor
Tianjin Medical University Cancer Institute and Hospital
Target Recruit Count
65
Registration Number
NCT05686434
Locations
🇨🇳

Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China

First in Human Study of AZD9592 in Solid Tumors

First Posted Date
2022-12-12
Last Posted Date
2024-12-17
Lead Sponsor
AstraZeneca
Target Recruit Count
162
Registration Number
NCT05647122
Locations
🇨🇳

Research Site, Taoyuan, Taiwan

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