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

A Study to Investigate the Safety and Efficacy of KQB198 As Monotherapy and in Combination in Participants with Advanced Solid Malignancies

Phase 1

Recruiting

Conditions: Solid Tumor, Adult

Interventions: Drug: KQB198
Drug: osimertinib

First Posted Date: 2024-07-18

Last Posted Date: 2024-12-05

Lead Sponsor: Kumquat Biosciences Inc.

Target Recruit Count: 100

Registration Number: NCT06507306

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, Long Island City, New York, United States
🇪🇸
Hospital Universitario Ramon y Cajal, Madrid, Spain
🇪🇸
START Madrid - Hospital Fundacion Jimenez Diaz, Madrid, Spain

and more 9 locations

EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study

Phase 3

Recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Afatinib/Dacomitinib
Drug: Osimertinib

First Posted Date: 2024-07-03

Last Posted Date: 2024-07-03

Lead Sponsor: Region Skane

Target Recruit Count: 200

Registration Number: NCT06486142

Locations: 🇸🇪
Skåne university hospital, Lund, Sweden

The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer

Phase 2

Not yet recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Osimertinib

First Posted Date: 2024-06-27

Last Posted Date: 2024-06-27

Lead Sponsor: Hunan Province Tumor Hospital

Target Recruit Count: 60

Registration Number: NCT06477055

Osimertinib and Etoposide as First-Line Treatment in Osimertinib-Resistant Advanced EGFR-Mutant NSCLC

Phase 2

Not yet recruiting

Conditions: Non-small Cell Lung Cancer Stage IV
Non Small Cell Lung Cancer
EGFR Gene Mutation
Non Small Cell Lung Cancer Stage IIIB

Interventions: Drug: Osimertinib

First Posted Date: 2024-05-30

Last Posted Date: 2024-05-30

Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Target Recruit Count: 93

Registration Number: NCT06436144

A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 3

Recruiting

Conditions: Metastatic Non-small Cell Lung Cancer

Interventions: Drug: Dato-DXd
Drug: Pemetrexed
Drug: Osimertinib
Drug: Carboplatin
Drug: Cisplatin

First Posted Date: 2024-05-16

Last Posted Date: 2024-12-20

Lead Sponsor: AstraZeneca

Target Recruit Count: 630

Registration Number: NCT06417814

Locations: 🇻🇳
Research Site, Hanoi, Vietnam

Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma

Phase 2

Recruiting

Conditions: Lung Cancer
Carcinoma, Squamous Cell

Interventions: Drug: Osimertinib

First Posted Date: 2024-04-25

Last Posted Date: 2024-05-09

Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Target Recruit Count: 51

Registration Number: NCT06383728

Locations: 🇨🇳
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations

Phase 1

Recruiting

Conditions: NSCLC

Interventions: Drug: BPI-1178
Drug: Osimertinib

First Posted Date: 2024-04-12

Last Posted Date: 2024-07-10

Lead Sponsor: National Cancer Center, China

Target Recruit Count: 20

Registration Number: NCT06362980

Locations: 🇨🇳
National Cancer Center, Beijing, China

Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer

Phase 3

Recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Osimertinib
Drug: Datopotamab Deruxtecan

First Posted Date: 2024-04-05

Last Posted Date: 2024-12-18

Lead Sponsor: AstraZeneca

Target Recruit Count: 582

Registration Number: NCT06350097

Locations: 🇻🇳
Research Site, Vinh, Vietnam

Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022)

Phase 3

Not yet recruiting

Conditions: Lung Cancer
EGFR Gene Mutation
Minimal Residual Disease

Interventions: Drug: No adjuvant therapy
Drug: Osimertinib

First Posted Date: 2024-03-21

Last Posted Date: 2024-03-21

Lead Sponsor: Fudan University

Target Recruit Count: 226

Registration Number: NCT06323148

High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases

Phase 2

Not yet recruiting

Conditions: Lung Cancer, Nonsmall Cell

Interventions: Drug: Furmonertinib
Drug: Osimertinib

First Posted Date: 2024-03-20

Last Posted Date: 2024-03-20

Lead Sponsor: Taizhou Hospital

Target Recruit Count: 255

Registration Number: NCT06319950

Drug Development Updates

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