Clinical trials: Osimertinib, completed
Oncology
A Phase I, Open-label Study to Assess Bioavailability of a Single Oral Dose of AZD9291 vs an IV Dose of [14C]AZD9291
The Sponsor is developing the study drug, AZD9291, for the potential treatment of nonsmall cell lung cancer. Lung cancer has been the most common cancer in the world for several decades and represents 12.8% of all new cancer…
- Trial name
- NCT02491944
- Testing
- AZD9291, [14C]AZD9291
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Non-small Cell Lung Cancer
A Study of Ramucirumab (LY3009806) or Necitumumab (LY3012211) Plus Osimertinib in Participants With Lung Cancer
The main purpose of this study is to evaluate the safety of ramucirumab or necitumumab in combination with osimertinib in participants with non-small cell lung cancer (NSCLC).
- Trial name
- NCT02789345
- Testing
- Ramucirumab, Necitumumab, Osimertinib
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 29 people
- Sponsor
- Eli Lilly and Company
Non Small Cell Lung Cancer
Study to Assess the Effect of AZD9291 on the Blood Levels of Simvastatin in Patients With EGFRm+ NSCLC
This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer (NSCLC), who have progressed following prior…
- Trial name
- NCT02197234
- Testing
- Pharmacokinetic sampling - AZD9291, Simvastatin, AZD9291 tablet dosing
- Where
- 16 sites in United States, Belgium and 3 more
- Volunteers
- 52 people
- Sponsor
- AstraZeneca
Advanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma
Osimertinib and Navitoclax in Treating Patients With EGFR-Positive Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer
This phase Ib trial studies the side effects and best dose of osimertinib and navitoclax when given together and to see how well they work in treating patients with previously treated epidermal growth factor receptor…
- Conditions
- Advanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma, Stage III Lung Non-Small Cell Cancer AJCC v7, Stage IIIA Lung Non-Small Cell Cancer AJCC v7
- Trial name
- NCT02520778
- Testing
- Navitoclax, Osimertinib
- Where
- 18 sites in United States
- Volunteers
- 27 people
- Sponsor
- National Cancer Institute (NCI)
Locally Advanced or Metastatic EGFR T790M+ NSCLC
Study of AZD9291 Plus MEDI4736 Versus AZD9291 Monotherapy in NSCLC After Previous EGFR TKI Therapy in T790M Mutation Positive Tumours
A Phase III, Multi-Centre, Open Label, Randomized Study to Assess the Efficacy and Safety of AZD9291 in Combination with MEDI4736 versus AZD9291 Monotherapy in patients with Locally Advanced or Metastatic Epidermal Growth Factor…
- Trial name
- CAURAL (NCT02454933)
- Testing
- AZD9291, MEDI4736
- Where
- 13 sites in Canada, South Korea and 1 more
- Volunteers
- 29 people
- Sponsor
- AstraZeneca
Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung), Drug-Related Side Effects and Adverse Reactions (MeSH Term)
Cancer Therapy-Related Cardiac Dysfunction Associated With EGFR-TKIs in Advanced EGFR-mutant Non-small Cell Lung Cancer
This study investigated the incidence of cardiac dysfunction in patients with advanced or recurrent epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer treated with EGFR- tyrosine kinase inhibitors.
- Conditions
- Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung), Drug-Related Side Effects and Adverse Reactions (MeSH Term), Egfr Tyrosine Kinase Inhibitor, Cardiotoxicity
- Trial name
- NCT07267247
- Testing
- EGFR-TKI, EGFR tyrosine kinase inhibitor
- Where
- Taiwan
- Volunteers
- 100 people
- Sponsor
- Taichung Veterans General Hospital
Non-small Cell Lung Cancer, EGFR-mutant Lung Cancers
Osimertinib and Bevacizumab as Treatment for EGFR-mutant Lung Cancers
The purpose of this study is to test the safety of combining the drugs osimertinib and bevacizumab at different dose levels. The investigators want to find out what effects, good and/or bad, taking osimertinib and bevacizumab has…
- Trial name
- NCT02803203
- Testing
- osimertinib, Bevacizumab
- Where
- 7 sites in United States
- Volunteers
- 49 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Non-Small Cell Lung Cancer
Osimertinib (AZD9291) in First-line Locally Advanced or Metastatic NSCLC Patients With EGFR and EGFR T790M
The primary goal is to evaluate the efficacy of osimertinib (AZD9291), in terms of the objective response rate in patients with advanced non-squamous NSCLC with EGFR mutations and the EGFR T790M mutation at diagnosis as defined…
- Trial name
- AZENT (NCT02841579)
- Testing
- Osimertinib
- Where
- 7 sites in Spain
- Volunteers
- 22 people
- Sponsor
- MedSIR
Non Small Cell Lung Cancer
Osimertinib in Subjects With Advanced Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive
This is a retrospective, multicenter and observational study of Osimertinib monotherapy treatment in Subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) EGFR-T790M mutation-positive who have received the…
- Trial name
- OSIREX (NCT03790397)
- Testing
- Osimertinib
- Where
- 31 sites in Spain
- Volunteers
- 169 people
- Sponsor
- Fundación GECP
Non-Small Cell Lung Cancer
A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.
The main purpose of the study is to learn about the effectiveness and treatment sequence of lung cancer medicines. This study is performed outside of clinical trials in Norway in patients with metastatic non-small cell lung…
- Trial name
- DELINOR (NCT05834348)
- Testing
- lorlatinib, crizotinib, brigatinib
- Where
- Norway
- Volunteers
- 5,279 people
- Sponsor
- Pfizer
Non Small Cell Lung Cancer
Phase II AZD9291 Open Label Study in NSCLC After Previous EGFR TKI Therapy in EGFR and T790M Mutation Positive Tumours
A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor…
- Trial name
- AURA2 (NCT02094261)
- Testing
- AZD9291
- Where
- 44 sites in United States, Canada and 6 more
- Volunteers
- 210 people
- Sponsor
- AstraZeneca
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
Pharmacokinetic Boosting of Osimertinib
The main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. AUC) is increased when osimertinib is co-administered with cobicistat in patients with relatively low plasma trough concentration while…
- Trial name
- OSIBOOST (NCT03858491)
- Testing
- Cobicistat
- Where
- 2 sites in Netherlands
- Volunteers
- 11 people
- Sponsor
- Academisch Ziekenhuis Maastricht
Carcinoma, Non-Small-Cell Lung
ctDNA Guided Treatment of Early Resistance to Targeted Treatment
The current strategy is to test for treatment resistance at the time of radiological progression and design subsequent treatment based on the mechanism of resistance.
- Trial name
- TATIN (NCT04148066)
- Testing
- ctDNA blood sample
- Where
- 2 sites in Netherlands
- Volunteers
- 104 people
- Sponsor
- The Netherlands Cancer Institute
Non-small Cell Lung Cancer
A Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Osimertinib in Clinical Practice Among Chinese NSCLC Patients
This is a multi-center, prospective, non-interventional study. The study will enroll about 1700 Chinese patients diagnosed as NSCLC and treated with osimertinib at least one dose.
- Trial name
- NCT03485326
- Where
- 29 sites in China
- Volunteers
- 1,700 people
- Sponsor
- AstraZeneca
NSCLC Stage IV, EGFR Activating Mutation
SRT for Residual Oligometastases of NSCLC After 3rd Generation EGFR-TKIs
This study is an open-label, single-arm phase 2 trial to evaluate the efficacy and safety of stereotactic radiotherapy (SRT) for patients with oligo-residual NSCLC after 3rd generation EGFR-TKIs.
- Trial name
- NCT04764214
- Testing
- 3rd generation EGFR-TKI, Consolidative SRT
- Where
- China
- Volunteers
- 61 people
- Sponsor
- Fudan University
Non Small Cell Lung Cancer
A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations
This is a research study to find out if a drug called, osimertinib, is safe and effective in treating advanced Non-Small Cell Lung Cancer (NSCLC) by targeting the treatment of epidermal growth factor receptor (EGFR) mutation exon…
- Trial name
- NCT03434418
- Testing
- osimertinib
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- Duke University
Bronchial Neoplasms
EGF816 and Trametinib in Patients With Non-small Cell Lung Cancer Harboring Activating EGFR Mutations
The aim of this trial is to identify the maximum tolerated dose (MTD)/recommended phase II dose (RP2D), to define pharmacokinetic (PK) parameters and the preliminary efficacy of a continuous treatment with EGF816 and trametinib…
- Trial name
- EATON (NCT03516214)
- Testing
- EGF816, Trametinib
- Where
- 7 sites in Germany, Spain
- Volunteers
- 18 people
- Sponsor
- University of Cologne
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
Osimertinib Treatment on EGFR T790M Plasma Positive NSCLC Patients (APPLE)
The phase II APPLE trial gives the opportunity to prospectively validate liquid biopsies as a new standard for testing tumor progression compared with conventional radiological procedure in EGFR mutant advanced NSCLC patients.
- Trial name
- APPLE (NCT02856893)
- Testing
- Osimertinib, Gefitinib
- Where
- 23 sites in Belgium, France and 4 more
- Volunteers
- 156 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC