Clinical trials: Osimertinib
Non Small Cell Lung Cancer
Liquid Biopsy as a Tool to Evaluate Resistance to First and Third (AZD9291) (EGFR) (TKIs) in (EGFR) Mutant NSCLC
Based on the possibilities that both plasma and circulating tumor cells (CTCs) (the "liquid biopsy") may offer, we consider that it could be feasible to longitudinally monitor the genetic evolution and the biologic…
- Trial name
- NCT02771314
- Testing
- AZD9291
- Where
- 13 sites in Greece
- Volunteers
- 48 people
- Sponsor
- Hellenic Oncology Research Group
Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain
Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases
This phase II trial studies how well osimertinib with or without bevacizumab works in treating patients with EGFR positive non-small cell lung cancer that has spread to the brain (brain metastases).
- Conditions
- Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Stage IV Lung Cancer AJCC v8
- Trial name
- NCT02971501
- Testing
- Bevacizumab, Biopsy Procedure, Biospecimen Collection
- Where
- 18 sites in United States
- Volunteers
- 5 people
- Sponsor
- National Cancer Institute (NCI)
NSCLC
Best EGFR-TKI Sequence in NSCLC Harboring EGFR Mutations
The best drug sequencing of dacomitinib or osimertinib in patients with advanced or metastatic Epidermal Growth Factor Receptor (EGFR) mutation positive non-small-cell lung cancer (NSCLC) has not yet been determined.
- Trial name
- CAPLAND (NCT04811001)
- Testing
- Osimertinib, Dacomitinib
- Where
- 20 sites in Italy
- Volunteers
- 170 people
- Sponsor
- Fondazione Ricerca Traslazionale
Neurocognitive
Neurocognition in NSCLC Patients Treated With Osimertinib or Osimertinib + WBI
This is a prospective, randomised, positive-controlled, study to assess the neurocognitive function of upfront Osimertinib compared to whole-brain irradiation (WBI) plus Osimertinib in EGFR-mutant (Ex 19Del and L858R) NSCLC…
- Trial name
- NCT04829019
- Testing
- Osimertinib and whole-brain irradiation, Osimertinib
- Where
- China
- Volunteers
- 88 people
- Sponsor
- Sun Yat-sen University
Non-small Cell Lung Cancer
A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer(PANKU-Lung04)
This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib versus osimertinib as first-Line treatment in patients with…
- Trial name
- NCT06838273
- Testing
- BL-B01D1, Osimertinib
- Where
- China
- Volunteers
- 720 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Advanced Non Small Cell Lung Cancer, Advanced (Inoperable) Non Small Cell Lung Cancer
Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291, in Patients With EGFR Positive Non-small Cell Lung Cancer. Patients Will be Chosen From Those Who Have Already Been Prescribed an EGFR TKI Medicine (Such as Iressa or Tarceva)
This is a 2 part study in patients with EGFRm+ non small cell lung cancer (NSCLC), whose disease has progressed on an EGFRm TKI, who are refractory or resistant to standard therapy.
- Trial name
- NCT02157883
- Testing
- Pharmacokinetic sampling, AZD9291, Itraconazole
- Where
- 16 sites in United States, Belgium and 4 more
- Volunteers
- 39 people
- Sponsor
- AstraZeneca
Non-small Cell Lung Cancer
A Phase 2 Study of Osimertinib in Combination With Selumetinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer
This research study is studying a combination of two targeted therapies as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation. The drugs involved in this study are: Osimertinib (Tagrisso) Selumetinib
- Trial name
- NCT03392246
- Testing
- Osimertinib, Selumetinib
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Dana-Farber Cancer Institute
Non Small Cell Lung Cancer NSCLC
A Prospective Multicenter Study of the Association Between TCM Syndromes and EGFR-TKI Efficacy in Lung Cancer Patients
The goal of this observational study is to learn about the relationship between TCM body constitution patterns (called "syndromes") and the effectiveness of EGFR-TKI targeted drugs in patients with lung cancer.
- Trial name
- NCT07338396
- Testing
- EGFR-TKI
- Where
- 6 sites in China
- Volunteers
- 3,000 people
- Sponsor
- Guangzhou University of Traditional Chinese Medicine
Non-squamous NSCLC
AFAMOSI: Efficacy and Safety of Afatinib Followed by Osimertinib Compared to Osimertinib in Patients with EGFRmutated/T790M Mutation Negative Nonsquamous NSCLC
This randomized, open label Phase IV trial will be performed in patients with a diagnosis of advanced NSCLC (non-squamous cell histology), harboring EGFR mutation positive but T790M Mutation negative, who have no previous…
- Trial name
- NCT04413201
- Testing
- Afatinib, Osimertinib
- Where
- 11 sites in Germany
- Volunteers
- 34 people
- Sponsor
- Michael Hopp
Lung Cancer, Carcinoma, Squamous Cell
Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma
Previous trials, such as ADURA and CTONG, have demonstrated the benefits of neoadjuvant targeted therapy in patient with EGFR mutations , which can effectively reduce the extent of tumors and improve the survival outcomes.
- Trial name
- GALAXY-02 (NCT06383728)
- Testing
- Osimertinib
- Where
- China
- Volunteers
- 51 people
- Sponsor
- The First Affiliated Hospital of Guangzhou Medical University
Non-small Cell Lung Cancer (NSCLC), EGFR-TKI Resistant Mutation
A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment
For patients of advanced NSCLC (non small cell lung cancer) , Individualized cancer therapy has been widely accepted since the success of crizotinib administration based on EML4-ALK fusion gene detection and gefitinib and…
- Conditions
- Non-small Cell Lung Cancer (NSCLC), EGFR-TKI Resistant Mutation, EGFR-TKI Sensitizing Mutation, Germline Mutations
- Trial name
- NCT01994057
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Sun Yat-sen University
Advanced Solid Tumours, Carcinoma Non-small Cell Lung
First in Human Study of AZD9592 in Solid Tumors
This is a first-in-human (FIH) Phase I, multi-center, open-label, study of AZD9592, in patients with advanced solid tumors. The study consists of several study modules, each evaluating the safety, tolerability, preliminary…
- Conditions
- Advanced Solid Tumours, Carcinoma Non-small Cell Lung, Head and Neck Neoplasms, Colorectal Neoplasms
- Trial name
- EGRET (NCT05647122)
- Testing
- AZD9592, Osimertinib, 5-Fluorouracil (5-FU)
- Where
- 46 sites in United States, Australia and 9 more
- Volunteers
- 190 people
- Sponsor
- AstraZeneca
Lung Cancer
Therapy for Advanced NSCLC With EGFR 19delins Mutation
In a retrospective analysis of 3,054 advanced NSCLC patients, 41 with EGFR exon 19 deletion-insertions (19delins) received first-generation EGFR TKIs, achieving median PFS of 10.4 months; those with L747_T751delinsP had notably…
- Trial name
- NCT07458919
- Testing
- Icotinib/Gefitinib
- Volunteers
- 94 people
- Sponsor
- Fuzhou General Hospital
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
Lung Cancer, Non-small Cell, EGFR Gene Mutation
Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)
Lung cancer is currently the world's largest malignant tumor for cancer-related deaths with non-small cell lung cancer (NSCLC) accounting for 80%-85%.
- Conditions
- Lung Cancer, Non-small Cell, EGFR Gene Mutation, EGFR-TKI Resistant Mutation, Primary Resistance
- Trial name
- PRECISE (NCT05598528)
- Testing
- Genomic profiles detection, circulating tumor DNA detection
- Where
- China
- Volunteers
- 210 people
- Sponsor
- Second Xiangya Hospital of Central South University
Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma
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
This phase I trial studies the safety, side effects and best dose of necitumumab when given together with osimertinib in treating patients with EGFR-mutant non-small cell lung cancer that is stage IV or has come back after a…
- Conditions
- Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
- Trial name
- NCT02496663
- Testing
- Biospecimen Collection, Computed Tomography, Echocardiography Test
- Where
- 15 sites in United States
- Volunteers
- 138 people
- Sponsor
- National Cancer Institute (NCI)
Non Small Cell Lung Cancer
A Window of Opportunity Study for Investigating Drug Tolerant Persister (DTP) to Neoadjuvant Osimertinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harbouring EGFR Mutations
Osimertinib is a third-generation EGFR (Epidermal growth factor receptor) TKI(Tyrosine kinase inhibitor) for the management of NSCLC(non-small cell lung cancer) harbouring EGFR(Epidermal growth factor receptor) T790M mutation…
- Trial name
- NCT04816838
- Testing
- Osimertinib
- Where
- South Korea
- Volunteers
- 25 people
- Sponsor
- Yonsei University
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
IIIb/IV NSCLC With T790M Positive Mutations Failed to Osimertinib Therapy
Efficacy and Safety of Toripalimab (JS001) Combined With Pemetrexed and Anlotinib for Patients With T790M Positive Non-Small Cell Lung Cancer After Osimertinib Resistance
This is an open-label, single-arm, multi-center, phase II exploratory study that evaluates the efficacy and safety of Toripalimab injection (JS001) combined with Pemetrexed and Anlotinib as a second-line treatment for patients…
- Trial name
- NCT04316351
- Testing
- Toripalimab + Pemetrexed + Anlotinib
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Guangzhou Institute of Respiratory Disease
Solid Tumor, Adult, Mesothelioma
Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors
This is an open-label, dose escalation and expansion study to evaluate the safety, tolerability, PK, and biological activity of VT3989 administered, alone or in combination, once daily in patients with mesothelioma and/or…
- Conditions
- Solid Tumor, Adult, Mesothelioma, NSCLC
- Trial name
- NCT04665206
- Testing
- VT3989, Nivolumab & Ipilimumab, Osimertinib
- Where
- 12 sites in United States, Australia
- Volunteers
- 434 people
- Sponsor
- Vivace Therapeutics, Inc