Clinical trials: Osimertinib
Carcinoma, Non-Small-Cell Lung
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del]…
- Trial name
- MARIPOSA (NCT04487080)
- Testing
- Amivantamab, Osimertinib, Lazertinib
- Where
- 269 sites in United States, Argentina and 26 more
- Volunteers
- 1,074 people
- Sponsor
- Janssen Research & Development, LLC
Non Small Cell Lung Cancer (NSCLC)
Osimertinib Study in Indian Patients
This is a prospective, single-arm, multicenter, phase-IV study investigating the safety of osimertinib in Indian adult patients.
- Trial name
- NCT03853551
- Testing
- Osimertinib
- Where
- 7 sites in India
- Volunteers
- 60 people
- Sponsor
- AstraZeneca
Non-Small Cell Lung Cancer
A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)
The reason for the study is to find out if an experimental combination of an oral medication called osimertinib (TAGRISSO®) when used in combination with chemotherapy is more effective than giving osimertinib alone for the…
- Trial name
- FLAURA2 (NCT04035486)
- Testing
- Osimertinib, Pemetrexed/Carboplatin, Pemetrexed/Cisplatin
- Where
- 153 sites in United States, Argentina and 19 more
- Volunteers
- 587 people
- Sponsor
- AstraZeneca
Lung Cancer
Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC
The aim of this study is to assess the efficacy and safety of single agent AZD9291 in a real world setting in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive Non-Small…
- Trial name
- ASTRIS (NCT02474355)
- Testing
- T790M+ Testing, Baseline Visit Blood & Urine Testing, Baseline ECG
- Where
- 201 sites in Argentina, Australia and 14 more
- Volunteers
- 3,017 people
- Sponsor
- AstraZeneca
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
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
NSCLC
Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer
Aumolertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets EGFR mutations.
- Trial name
- NCT05493501
- Testing
- Aumolertinib monotherapy, Osimertinib monotherapy, Pemetrexed
- Where
- 8 sites in United States
- Volunteers
- 8 people
- Sponsor
- EQRx International, Inc.
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
Non-small Cell Lung Cancer
A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)
This study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor…
- Trial name
- NCT03940703
- Testing
- Tepotinib, Osimertinib
- Where
- 179 sites in United States, Belgium and 15 more
- Volunteers
- 140 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Carcinoma, Non-Small-Cell Lung
A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure
The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and…
- Trial name
- MARIPOSA-2 (NCT04988295)
- Testing
- Lazertinib, Amivantamab, Pemetrexed
- Where
- 249 sites in United States, Argentina and 27 more
- Volunteers
- 776 people
- Sponsor
- Janssen Research & Development, LLC
Advanced Non Small Cell Lung Cancer, Advanced (Inoperable) Non Small Cell Lung Cancer
AZD9291 First Time In Patients Ascending Dose Study
This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment.
- Trial name
- AURA (NCT01802632)
- Testing
- AZD9291
- Where
- 45 sites in United States, Australia and 8 more
- Volunteers
- 603 people
- Sponsor
- AstraZeneca
Solid Tumor
Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of RMC-4630 and cobimetinib in adult participants with relapsed/refractory solid tumors with specific…
- Trial name
- NCT03989115
- Testing
- RMC-4630, Cobimetinib, Drug: Osimertinib
- Where
- 24 sites in United States, South Korea
- Volunteers
- 113 people
- Sponsor
- Revolution Medicines, Inc.
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
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
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 (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
Advanced NSCLC
Real-World Study on Gene Profile in Patients With Advanced NSCLC Who Progressed on First-Line Osimertinib Therapy(GPS).
Although some small sample studies have reported the possible resistance mechanisms of Osimertinib in the first-line treatment, it is still an urgent need to explore the whole gene profile in EGFRm advanced NSCLC patients post…
- Trial name
- GPS (NCT05219162)
- Testing
- Gene Profile explore
- Where
- 16 sites in China
- Volunteers
- 182 people
- Sponsor
- AstraZeneca
Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung Cancer
AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer
- Trial name
- FLAURA (NCT02296125)
- Testing
- Erlotinib 150/100 mg, Gefitinib 250 mg
- Where
- 170 sites in United States, Australia and 28 more
- Volunteers
- 674 people
- Sponsor
- AstraZeneca
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