Clinical trials: Osimertinib, completed
All Patients Treated With the Product
Tagrisso Tablets Clinical Experience Investigation (All Case Investigation)
Clinical experience investigation (CEI) is to be conducted to confirm the following to characterise safety and efficacy of Tagrisso Tablets in actual clinical use. 1.
- Trial name
- NCT02756039
- Where
- 47 sites in Japan
- Volunteers
- 3,494 people
- Sponsor
- AstraZeneca
Advanced Non Small Cell Lung Cancer, Advanced (Inoperable) Non Small Cell Lung Cancer
Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer
This is a 2-part study in patients with epidermal growth factor receptor mutation positive (EGFRm+) non-small cell lung cancer (NSCLC) whose disease has progressed on treatment with an epidermal growth factor receptor…
- Trial name
- NCT02163733
- Testing
- AZD9291 tablets, Pharmacokinetic sampling - AZD9291, Dietary Fasted
- Where
- 13 sites in France, South Korea and 2 more
- Volunteers
- 38 people
- Sponsor
- AstraZeneca
T790M Positive NSCLC Patients
Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC
To assess the effectiveness and safety of osimertinib treatment in a real world setting.
- Trial name
- NCT03133234
- Testing
- osimertinib
- Where
- China
- Volunteers
- 47 people
- Sponsor
- AstraZeneca
EGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib
A multicentre, open-label, single-arm, molecular profiling study of patients with EGFR mutation-positive locally advanced or metastatic NSCLC treated with osimertinib.
- Trial name
- ELIOS (NCT03239340)
- Testing
- Osimertinib
- Where
- 26 sites in United States, Italy and 3 more
- Volunteers
- 154 people
- Sponsor
- AstraZeneca
NSCLC, EGFR T790M
Exploring the Theragnostic Value of Osimertinib in EGFR-mutated Lung Cancer (THEROS)
This is a single arm, open label, multicentric proof-of-concept, phase II study in patients with EGFR-mutated non-small-cell lung cancer (NSCLC) with acquired TKI resistance who are "unknown" for EGFR T790M status due to…
- Conditions
- NSCLC, EGFR T790M, FDG-PET
- Trial name
- NCT03810066
- Testing
- Osimertinib
- Where
- Germany
- Volunteers
- 16 people
- Sponsor
- University Hospital, Essen
Non-Small Cell Lung Cancer With EGFR Mutation, Locally Advanced Solid Tumor
Advanced Lung Tumor Treated by Osimertinib Plus Anlotinib
This is a prospective, single arm, phase Ib/IIa study. Up to 25 patients will be enrolled into the study (Part A: 2-18; Part B: 7-19).
- Conditions
- Non-Small Cell Lung Cancer With EGFR Mutation, Locally Advanced Solid Tumor, Metastatic Cancer, Adenocarcinoma of Lung
- Trial name
- AUTOMAN (NCT04770688)
- Testing
- Osimertinib, Anlotinib
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Shanghai Chest Hospital
Non-small Cell Lung Cancer
Resistance & Activating Mutations Diagnosed Among NSCLC Community Dwelling EGFR Mutation Positive Patients
The study is being done to determine if non-invasive testing (urine and plasma testing) is as effective as tissue testing in identifying epidermal growth factor receptor (EGFR) T790M mutation status.
- Trial name
- RADIANCE (NCT03137264)
- Testing
- Other
- Where
- 23 sites in United States, Canada
- Volunteers
- 44 people
- Sponsor
- AstraZeneca
Non Small Cell Lung Cancer
Resistance to Oral Therapy in Lung Cancer
In the management of non-small cell lung cancer of the adenocarcinoma type, different therapeutic strategies can be proposed. These strategies are defined according to the results of a biological analysis of blood and/or tissue…
- Trial name
- RESTKI (NCT04546282)
- Testing
- Description of the molecular alterations detected in blood samples of patients treated by osimertinib
- Where
- France
- Volunteers
- 20 people
- Sponsor
- University Hospital, Montpellier
Metastatic Non Small Cell Lung Cancer
A Randomised Phase II Trial of Osimertinib With or Without SRS for EGFR Mutated NSCLC With Brain Metastases
20-40% of patients with NSCLC will develop brain metastases at some point during their course of disease. Osimertinib has demonstrated intracranial activity in EFGR mutated NSCLC with leptomeningeal disease in the phase 1 BLOOM…
- Trial name
- OUTRUN (NCT03497767)
- Testing
- Osimertinib, Stereotactic Radiosurgery (SRS)
- Where
- 13 sites in Australia, Singapore
- Volunteers
- 40 people
- Sponsor
- Trans Tasman Radiation Oncology Group
EGFR Gene Mutation, Lung Cancer
A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.
The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers.
- Conditions
- EGFR Gene Mutation, Lung Cancer, Lung Cancer Metastatic
- Trial name
- NCT03755102
- Testing
- Dacomitinib, Osimertinib
- Where
- 8 sites in United States
- Volunteers
- 17 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Lung Cancer
T790M Plasma Testing Methodology Comparison and Clinical Validation
The aim of this study is to evaluate concordance of T790M mutation plasma testing between the Cobas test and each of other platforms: Super-ARMS, digital PCR or NGS.
- Trial name
- ADELOS (NCT02997501)
- Testing
- T790M+ Testing, Baseline Visit Blood & Urine Testing, Baseline ECG
- Where
- 7 sites in China
- Volunteers
- 256 people
- Sponsor
- AstraZeneca
Lung Cancer Stage III, EGFR Activating Mutation
Thoracic Radiotherapy Plus EGFR-TKI for Stage III EGFR-mutant Lung Adenocarcinoma
Objective: To investigate the failure patterns, efficacy and safety of thoracic radiotherapy combined with EGFR-TKI in stage III unresectable non-small cell lung cancer harboring EGFR-sensitive mutations.
- Trial name
- NCT07857694
- Testing
- Thoracic radiotherapy, EGFR-TKI
- Where
- China
- Volunteers
- 202 people
- Sponsor
- Laibin People's Hospital
Lung Adenocarcinoma, Lung Neoplasms
Local Ablative Therapy for Treatment of Oligoprogressive, EGFR-Mutated, Non-Small Cell Lung Cancer After Treatment With Osimertinib
Background: Some non-small-cell lung cancers (NSCLC) have a mutation in a gene that makes a protein called EGFR. This particular cancer can be treated with certain drugs such as erlotinib (Tarceva), gefitinib (Iressa) and…
- Trial name
- NCT02759835
- Testing
- osimertinib, Local Ablative Therapy (LAT)
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- National Cancer Institute (NCI)
Non-small Cell Lung Cancer
An Autologous NK/CIK Cell Product (PB101) in Combination With EGFR-TKI for Treating Lung Cancer
This study was designed to determine the safety and tolerability of PB101 (autologous NK cell product) in combination with standard of care EGFR-TKI in patients with EGFR-mutated advanced non-small cell lung cancer.
- Trial name
- NCT07271446
- Testing
- PB101 plus EGFR-TKI including gefitinib, erlotinib, afatinib, or osimertinib
- Where
- Taiwan
- Volunteers
- 8 people
- Sponsor
- Precision Biotech Taiwan Corp.
Stage IIIB Non-small Cell Lung Cancer, Stage IIIC Non-Small Cell Lung Cancer
Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer
This study is to evaluate the tolerability and safety of ONO-7475 in combination with osimertinib in the first-line treatment of patients with EGFR-mutated, stage IIIB/IIIC/IV or recurrent non-small cell lung cancer (NSCLC)…
- Conditions
- Stage IIIB Non-small Cell Lung Cancer, Stage IIIC Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Recurrent Non-Small Cell Lung Cancer
- Trial name
- NCT06525246
- Testing
- ONO-7475, Osimertinib Mesylate
- Where
- 13 sites in Japan
- Volunteers
- 78 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Nonsmall Cell Lung Cancer
Assessing an Oral Janus Kinase Inhibitor, AZD4205, in Combination With Osimertinib in Patients Who Have Advanced Non-small Cell Lung Cancer
This study will treat patients with advanced NSCLC who have progressed following prior therapy. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may…
- Trial name
- JACKPOT1 (NCT03450330)
- Testing
- AZD4205
- Where
- 4 sites in Australia
- Volunteers
- 10 people
- Sponsor
- Dizal Pharmaceuticals
Locally Advanced or Metastatic NSCLC
Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation
This is a single-arm, non-randomized multicentre phase 2 study in NSCLC patients with EGFR exon 20 insertion mutation, whose disease has progressed on standard chemotherapy.
- Trial name
- NCT03414814
- Testing
- Osimertinib 80 MG [Tagrisso]
- Where
- South Korea
- Volunteers
- 15 people
- Sponsor
- Seoul National University Hospital
Non-small Cell Lung Cancer
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele fraction (AF) in a real-world setting.
- Trial name
- NCT03219970
- Testing
- Osimertinib
- Where
- 4 sites in China
- Volunteers
- 156 people
- Sponsor
- AstraZeneca
Non-Small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV
Combination of Osimertinib and Aspirin to Treat 1st Generation EGFR-TKI Resistance in NSCLC
The third generation epidermal growth gactor receptor-tyrosine Kinase Inhibitor（EGFR-TKI） osimertinib has obvious curative effect for EGFR sensitive mutation and T790M mutation(PMID 27959700), but acquired drug resistance will…
- Conditions
- Non-Small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV, EGFR T790M
- Trial name
- NCT03543683
- Testing
- Osimertinib, Aspirin
- Where
- China
- Volunteers
- 115 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Healthy Volunteers
Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD9291 in Volunteers
Study to evaluate the pharmacokinetic and Mass Balance of single dose [14C] AZD9291 in healthy male volunteers
- Trial name
- NCT02096679
- Testing
- AZD9291
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AstraZeneca