Osimertinib

Generic Name: Osimertinib

Brand Names: Tagrisso

Drug Type: Small Molecule

Chemical Formula: C_₂₈H_₃₃N_₇O_₂

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

Clinical Trials

Osimertinib and Navitoclax in Treating Patients With EGFR-Positive Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer

Phase 1

Completed

Conditions: Advanced Lung Non-Squamous Non-Small Cell Carcinoma
Stage IIIB Lung Non-Small Cell Cancer AJCC v7
Metastatic Lung Non-Squamous Non-Small Cell Carcinoma
Stage III Lung Non-Small Cell Cancer AJCC v7
Stage IV Lung Non-Small Cell Cancer AJCC v7
Stage IIIA Lung Non-Small Cell Cancer AJCC v7

Interventions: Drug: Navitoclax
Drug: Osimertinib

First Posted Date: 2015-08-13

Last Posted Date: 2024-08-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 27

Registration Number: NCT02520778

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

and more 15 locations

Testing the Combination of MLN0128 (TAK-228) and AZD9291 in Advanced EGFR (Epidermal Growth Factor Receptor) Mutation Positive Non-small Cell Lung Cancer

Phase 1

Active, not recruiting

Conditions: Metastatic Lung Non-Small Cell Carcinoma
Stage IIIB Lung Non-Small Cell Cancer AJCC v7
Stage IV Lung Non-Small Cell Cancer AJCC v7
Stage III Lung Non-Small Cell Cancer AJCC v7
Recurrent Lung Non-Small Cell Carcinoma
Stage IIIA Lung Non-Small Cell Cancer AJCC v7

Interventions: Other: Laboratory Biomarker Analysis
Drug: Osimertinib
Other: Pharmacological Study
Drug: Sapanisertib

First Posted Date: 2015-07-21

Last Posted Date: 2024-12-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 36

Registration Number: NCT02503722

Locations: 🇺🇸
Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, United States
🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇨🇦
BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, Canada

and more 2 locations

Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor

Phase 1

Active, not recruiting

Conditions: Recurrent Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Metastatic Lung Non-Small Cell Carcinoma

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Echocardiography
Procedure: Magnetic Resonance Elastography
Procedure: Multigated Acquisition Scan
Biological: Necitumumab
Drug: Osimertinib

First Posted Date: 2015-07-14

Last Posted Date: 2024-12-05

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 138

Registration Number: NCT02496663

Locations: 🇺🇸
Emory Saint Joseph's Hospital, Atlanta, Georgia, United States
🇺🇸
UCHealth University of Colorado Hospital, Aurora, Colorado, United States
🇺🇸
MedStar Georgetown University Hospital, Washington, District of Columbia, United States

and more 12 locations

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

Phase 2

Active, not recruiting

Conditions: Advanced Malignant Solid Neoplasm
Breast Carcinoma
Cervical Carcinoma
Liver Carcinoma
Malignant Uterine Neoplasm
Recurrent Gastric Carcinoma
Recurrent Head and Neck Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Prostate Carcinoma
Recurrent Rectal Carcinoma

Interventions: Drug: Afatinib
Drug: Capivasertib
Drug: Binimetinib
Drug: Adavosertib
Procedure: Biospecimen Collection
Other: Cytology Specimen Collection Procedure
Drug: Afatinib Dimaleate
Drug: Dabrafenib
Drug: Defactinib
Drug: Fexagratinib
Drug: Dasatinib
Drug: Ipatasertib
Procedure: Biopsy
Drug: Crizotinib
Drug: Dabrafenib Mesylate
Drug: Taselisib
Drug: Sapanisertib
Drug: PI3K-beta Inhibitor GSK2636771
Drug: Defactinib Hydrochloride
Drug: Palbociclib
Biological: Nivolumab
Drug: Copanlisib
Drug: Ulixertinib
Biological: Trastuzumab Emtansine
Drug: Copanlisib Hydrochloride
Biological: Relatlimab
Procedure: Computed Tomography
Drug: Trametinib
Biological: Pertuzumab
Drug: Erdafitinib
Procedure: Radiologic Examination
Procedure: Multigated Acquisition Scan
Drug: Larotrectinib
Procedure: Echocardiography
Drug: Osimertinib
Biological: Trastuzumab
Drug: Larotrectinib Sulfate
Other: Laboratory Biomarker Analysis
Procedure: Magnetic Resonance Imaging
Drug: Vismodegib
Drug: Sunitinib Malate
Procedure: Radionuclide Imaging

First Posted Date: 2015-06-08

Last Posted Date: 2024-12-19

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 6452

Registration Number: NCT02465060

Locations: 🇺🇸
Alaska Women's Cancer Care, Anchorage, Alaska, United States
🇺🇸
Anchorage Oncology Centre, Anchorage, Alaska, United States
🇺🇸
Katmai Oncology Group, Anchorage, Alaska, United States

and more 1416 locations

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)

Phase 3

Active, not recruiting

Conditions: Metastatic Non-Small Cell Lung Cancer

Interventions: Drug: Placebo
Drug: Ramucirumab
Drug: Erlotinib
Drug: Gefitinib
Drug: Osimertinib

First Posted Date: 2015-04-08

Last Posted Date: 2024-08-29

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 545

Registration Number: NCT02411448

Locations: 🇺🇸
UCLA Hematology/Oncology - Santa Monica, Los Angeles, California, United States
🇺🇸
AHN Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
🇯🇵
Hyogo Prefectual Amagasaki General Medical Center, Amagashiki, Hyogo, Japan

and more 103 locations

A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors

Phase 1

Active, not recruiting

Conditions: Advanced Solid Tumors Cancer

Interventions: Drug: Nivolumab
Drug: Telisotuzumab vedotin
Drug: Osimertinib
Drug: Erlotinib

First Posted Date: 2014-03-28

Last Posted Date: 2024-06-18

Lead Sponsor: AbbVie

Target Recruit Count: 237

Registration Number: NCT02099058

Locations: 🇺🇸
University of California, Los Angeles /ID# 148295, Los Angeles, California, United States
🇺🇸
Massachusetts General Hospital /ID# 129804, Boston, Massachusetts, United States
🇺🇸
Duke Cancer Center /ID# 123763, Durham, North Carolina, United States

and more 33 locations

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