Clinical trials: Osimertinib
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
Non-small Cell Lung Cancer
A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)
The study will evaluate the efficacy and safety of treatment with chemotherapy in combination with osimertinib compared to chemotherapy in combination with placebo in patients whose disease has progressed extracranially following…
- Trial name
- COMPEL (NCT04765059)
- Testing
- Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin
- Where
- 40 sites in United States, China and 4 more
- Volunteers
- 98 people
- Sponsor
- AstraZeneca
Advanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma
Telaglenastat Hydrochloride and Osimertinib in Treating Patients With EGFR-Mutated Stage IV Non-small Cell Lung Cancer
This phase Ib trial studies the side effects and best dose of telaglenastat hydrochloride when given together with osimertinib in treating patients with stage IV non-small cell lung cancer and a mutation in the EGFR gene.
- Conditions
- Advanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
- Trial name
- NCT03831932
- Testing
- Biospecimen Collection, Computed Tomography, Magnetic Resonance Elastography
- Where
- 11 sites in United States
- Volunteers
- 22 people
- Sponsor
- National Cancer Institute (NCI)
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)
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
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
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Testing AZD9291 as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH-Subprotocol E)
This phase II MATCH treatment trial evaluates the effectiveness of osimertinib (AZD9291) in treating patients with cancer that has certain genetic changes called EGFR mutations.
- Conditions
- Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma
- Trial name
- NCT06303167
- Testing
- Biopsy Procedure, Biospecimen Collection, Echocardiography Test
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- National Cancer Institute (NCI)
Non Small Cell Lung Cancer
Study to Assess the Effect of AZD9291 on the Blood Levels of Rosuvastatin, in Patients With EGFRm+ Non-small Cell Lung Cancer
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
- NCT02317016
- Testing
- Pharmacokinetic sampling - AZD9291, AZD9291 tablet dosing, Rosuvastatin
- Where
- 13 sites in United States, France and 2 more
- Volunteers
- 44 people
- Sponsor
- AstraZeneca
Non Small Cell Lung Cancer Metastatic
Osimertinib and Bevacizumab Versus Osimertinib Alone as Second-line Treatment in Stage IIIb-IVb NSCLC With Confirmed EGFRm and T790M
BOOSTER is a randomised, controlled, phase II trial comparing osimertinib and bevacizumab versus osimertinib alone as second-line treatment in patients with stage IIIb-IVb non-small cell lung carcinoma (NSCLC) harbouring…
- Trial name
- BOOSTER (NCT03133546)
- Testing
- Osimertinib, Bevacizumab
- Where
- 25 sites in Ireland, Netherlands and 4 more
- Volunteers
- 155 people
- Sponsor
- ETOP IBCSG Partners Foundation
Metastatic Non-Small Cell Lung Cancer
A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)
The main purpose of this study is to evaluate the efficacy and safety of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in previously untreated participants with stage IV non-small…
- Trial name
- RELAY (NCT02411448)
- Testing
- Ramucirumab, Erlotinib, Gefitinib
- Where
- 106 sites in United States, Canada and 12 more
- Volunteers
- 545 people
- Sponsor
- Eli Lilly and Company
Carcinoma, Non-Small-Cell Lung
Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study
The objective of this study is to investigate the safety, tolerability, and antitumor activity of novel combination therapies administered in participants with advanced EGFRm NSCLC.
- Trial name
- NCT03381274
- Testing
- Oleclumab, Osimertinib, AZD4635
- Where
- 13 sites in United States, South Korea and 1 more
- Volunteers
- 43 people
- Sponsor
- MedImmune LLC
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)
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
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
Carcinoma, Non-Small-Cell Lung
Study Evaluating Efficacy and Safety of Capmatinib in Combination With Osimertinib in Adult Subjects With Non-small Cell Lung Cancers as Second Line Therapy
This study aimed to evaluate the anticancer activity of capmatinib in combination with osimertinib compared to platinum-pemetrexed based doublet chemotherapy as second line treatment in patients with advanced or metastatic…
- Trial name
- GEOMETRY-E (NCT04816214)
- Testing
- Capmatinib, Osimertinib, Pemetrexed
- Where
- 4 sites in Japan, Singapore and 1 more
- Volunteers
- 6 people
- Sponsor
- Novartis Pharmaceuticals
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
Phase II Single Arm Study of AZD9291 to Treat NSCLC Patients in Asia Pacific
A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Asia Pacific Patients with Locally Advanced/Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal…
- Trial name
- AURA17 (NCT02442349)
- Testing
- AZD9291
- Where
- 30 sites in Australia, China and 1 more
- Volunteers
- 171 people
- Sponsor
- AstraZeneca
Non-Small Cell Lung Cancer
A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer
This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable…
- Trial name
- NeoADAURA (NCT04351555)
- Testing
- Osimertinib, Cisplatin, Carboplatin
- Where
- 158 sites in United States, Austria and 23 more
- Volunteers
- 358 people
- Sponsor
- AstraZeneca
Advanced Breast Carcinoma, Advanced Malignant Solid Neoplasm
A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer
This phase II trial tests the how well a precision medicine approach (serial measurements of molecular and architectural response to therapy [SMMART])-adaptive clinical treatment [ACT]) works in treating patients with sarcoma…
- Conditions
- Advanced Breast Carcinoma, Advanced Malignant Solid Neoplasm, Advanced Ovarian Carcinoma, Advanced Pancreatic Carcinoma
- Trial name
- NCT06630325
- Testing
- Abemaciclib, Biopsy, Bone Scan
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- OHSU Knight Cancer Institute
Advanced or Metastatic Non-small Cell Lung Cancer
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human…
- Trial name
- PALOMA-3 (NCT05388669)
- Testing
- Lazertinib, Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF), Amivantamab Intravenous
- Where
- 187 sites in United States, Argentina and 18 more
- Volunteers
- 418 people
- Sponsor
- Janssen Research & Development, LLC