Clinical trials: Osimertinib
Non-small Cell Carcinoma, EGFR Gene Mutation
Osimertinib Monotherapy or Combination With Chemotherapy for Advanced NSCLC Concurrent EGFR and TP53 Mutations
This is a phase III randomized trial in patients with advanced non-squamous NSCLC harboring EGFR-sensitizing mutations and concurrent TP53 mutations with a performance status of 0 to1 who are planned to receive first-line therapy.
- Trial name
- TOP (NCT04695925)
- Testing
- Osimertinib, Pemetrexed, Carboplatin
- Where
- 2 sites in China
- Volunteers
- 294 people
- Sponsor
- Li Zhang, MD
Advanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma
Aurora Kinase Inhibitor LY3295668 in Combination With Osimertinib for the Treatment of Advanced or Metastatic EGFR-Mutant Non-squamous Non-small Cell Lung Cancer
This phase Ib/II trial studies the side effects and best dose of aurora A kinase inhibitor LY3295668 when given together with osimertinib in patients with EGFR-mutant non-squamous non-small cell lung cancer that has spread to…
- Conditions
- Advanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8
- Trial name
- NCT05017025
- Testing
- Aurora A Kinase Inhibitor LY3295668, Osimertinib
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- M.D. Anderson Cancer Center
NSCLC
TAGRISSO (Osimertinib) in NSCLC Patients in Whom T790 Mutations Are Detected by Liquid Biopsy
In this trial, anti-tumor efficacy of TAGRISSO in NSCLC patients in whom T790 mutations are detected by liquid biopsy.
- Trial name
- NCT03394118
- Testing
- Osimertinib
- Where
- South Korea
- Volunteers
- 63 people
- Sponsor
- Asan Medical Center
Non-small Cell Lung Cancer
Open-label PET Study With [11C]Osimertinib in Patients With EGFRm NSCLC and Brain Metastases
This is an open-label, single centre, Phase I study to determine the brain exposure of [11C]osimertinib in patients with EGFRm NSCLC with brain metastases.
- Trial name
- ODIN-BM (NCT03463525)
- Testing
- Osimertinib, [11C]osimertinib
- Where
- Sweden
- Volunteers
- 4 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
Advanced Non-squamous Non-small-cell Lung Cancer
A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC
To evaluate the safety and tolerability of escalating doses of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with advanced non-small cell lung cancer (NSCLC).
- Trial name
- HERKULES-2 (NCT04959981)
- Testing
- ERAS-007, ERAS-601, Osimertinib
- Where
- 11 sites in United States
- Volunteers
- 24 people
- Sponsor
- Erasca, Inc.
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer
This study is a Phase Ib, open label, multi-center study of to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (Afatinib or Osimertinib) in patients with locally advanced or metastatic non-small cell lung…
- Trial name
- NCT04448379
- Testing
- JMT101
- Where
- 13 sites in China
- Volunteers
- 48 people
- Sponsor
- Shanghai JMT-Bio Inc.
Healthy Volunteer
Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers
This is a Phase 1, open-label, 2-period fixed sequence design to evaluate the interaction of AZD9291 with omeprazole in approximately 50 healthy, adult male volunteers.
- Trial name
- NCT02224053
- Testing
- Pharmacokinetic sampling - AZD9291, AZD9291 tablet dosing, Omeprazole tablet dosing
- Where
- 2 sites in United States
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Non-Small Cell Lung Cancer
A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer
The researchers are doing this study to find out whether ivonescimab in combination with datopotamab deruxtecan- (Dato-DXd) or osimertinib are safe and effective treatments in people with non-small cell lung cancer (NSCLC) that…
- Trial name
- NCT07535437
- Testing
- Ivonescimab, Dato-DXd, Osimertinib
- Where
- 7 sites in United States
- Volunteers
- 66 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Lung Cancer
An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer
The purpose of this study is to evaluate the safety and tolerability of itacitinib in combination with osimertinib in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).
- Trial name
- NCT02917993
- Testing
- Itacitinib, Osimertinib
- Where
- 31 sites in United States, South Korea and 2 more
- Volunteers
- 59 people
- Sponsor
- Incyte Corporation
NSCLC
Almonertinib Versus Osimertinib in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases
This is a multicenter, randomized controlled, double-blind clinical trial. The study is designed to evaluate the efficacy and safety of high-dose Almonertinib versus Osimertinib in the second-line treatment of patients with EGFR…
- Trial name
- ATTACK (NCT04870190)
- Testing
- Almonertinib, Osimertinib
- Volunteers
- 232 people
- Sponsor
- Shanghai Chest Hospital
Locally Advanced or Metastatic Non-squamous NSCLC, Harboring EGFR Sensitive Mutations NSCLC
A Clinical Study of JMT101 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Sensitive Mutations
This is a Phase 3, randomized, positive-controlled, open-label clinical study. The primary objective is to evaluate the efficacy of JMT101 in combination with osimertinib versus osimertinib alone in patients with newly diagnosed…
- Conditions
- Locally Advanced or Metastatic Non-squamous NSCLC, Harboring EGFR Sensitive Mutations NSCLC, Previously Untreated Systematically NSCLC
- Trial name
- NCT06735391
- Testing
- JMT101, Osimertinib
- Where
- China
- Volunteers
- 516 people
- Sponsor
- Shanghai JMT-Bio Inc.
Non-small Cell Lung Cancer Stage III
A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in patients with unresectable EGFR-mutated Stage III non-small…
- Trial name
- NCT07640789
- Testing
- BL-B01D1, Osimertinib
- Where
- China
- Volunteers
- 418 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Carcinoma
Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib
This study (the SAVANNAH study) will investigate the efficacy of osimertinib in combination with savolitinib in participants with epidermal growth factor receptor mutation positive (EGFRm+) and mesenchymal epithelial transition…
- Trial name
- SAVANNAH (NCT03778229)
- Testing
- Osimertinib, Savolitinib
- Where
- 90 sites in United States, Brazil and 11 more
- Volunteers
- 367 people
- Sponsor
- AstraZeneca
Non-Small-Cell Lung Cancer
Combination of Vebreltinib and Osimertinib in Patients with EGFR 21 L858R Mutation Advanced NSCLC
This is a Prospective, open label, single arm study to evaluate the efficacy and safety of Vebreltinib combined with Osimertinib in the treatment of locally advanced or metastatic non-small cell lung cancer with EGFR 21 L858R…
- Trial name
- NCT06827145
- Testing
- Vebreltinib, Osimertinib
- Where
- China
- Volunteers
- 30 people
- Sponsor
- National Cancer Center, China
Non-small Cell Lung Cancer (NSCLC)
DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
This study has two parts: dose escalation and dose expansion. The primary objectives are: For Dose Escalation, to assess the safety and tolerability of DS-1205c when combined with osimertinib in the study population and to…
- Trial name
- NCT03255083
- Testing
- DS-1205c, Osimertinib
- Where
- 7 sites in Taiwan
- Volunteers
- 13 people
- Sponsor
- Daiichi Sankyo
Non Small Cell Lung Cancer
Osimertinib Plus Chemotherapy vs Osimertinib in EGFRm NSCLC With Persistence Week-3 ctDNA EGFRm After 1L Osimertinib
This is a prospective, randomised, open-label, positive-controlled study to investigate the efficacy and safety of Osimertinib plus Carboplatin/Pemetrexed versus Osimertinib monotherapy in locally advanced or metastatic EGFRm…
- Trial name
- FLAME (NCT04769388)
- Testing
- Osimertinib, Pemetrexed/Carboplatin
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Beijing Cancer Prevention & Treatment Society
Stage I Non-Small Cell Lung Cancer, Stage IA Non-Small Cell Lung Cancer
Osimertinib in Treating Participants With Stage I-IIIA EGFR-mutant Non-small Cell Lung Cancer Before Surgery
This phase II trial studies how well osimertinib works in treating participants with stage I-IIIA Epithelial Growth Factor Receptor (EGFR) -mutant non-small cell lung cancer before surgery.
- Conditions
- Stage I Non-Small Cell Lung Cancer, Stage IA Non-Small Cell Lung Cancer, Stage IB Non-Small Cell Lung Cancer, Stage II Non-Small Cell Lung Cancer
- Trial name
- NCT03433469
- Testing
- Osimertinib, Therapeutic Conventional Surgery
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- University of California, San Francisco
Healthy Volunteers
To Determine the Relative Bioavailability of Different Formulations of AZD9291 and the Effect of Food.
To determine the relative bioavailability of different oral formulations of AZD9291 and the effect of food in healthy volunteers.
- Trial name
- NCT01951599
- Testing
- AZD9291
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Non Small Cell Lung Cancer
TAURAS - T790 AURA ScreenFailure SOC Registry Study
The aim of this study is to evaluate clinical outcomes of 2nd line therapy in NSCLC patients without the T790M mutation, both independently and when compared indirectly with NSCLC patients with the T790M mutation in the T STAR…
- Trial name
- TAURAS (NCT02405247)
- Testing
- Patient Reported Outcome (PRO)
- Where
- 5 sites in United States, South Korea
- Volunteers
- 400 people
- Sponsor
- AstraZeneca