Clinical trials: Osimertinib
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
Anticancer Treatment
AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase III, Open Label, Randomized Study of Osimertinib versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal…
- Trial name
- AURA3 (NCT02151981)
- Testing
- Chemotherapy, Cross-over to Osimertinib
- Where
- 150 sites in United States, Australia and 16 more
- Volunteers
- 421 people
- Sponsor
- AstraZeneca
Advanced Non Small Cell Lung Cancer, Advanced (Inoperable) Non Small Cell Lung Cancer
Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer
This is a 2-part study in patients with epidermal growth factor receptor mutation positive (EGFRm+) non-small cell lung cancer (NSCLC) whose disease has progressed on treatment with an epidermal growth factor receptor…
- Trial name
- NCT02163733
- Testing
- AZD9291 tablets, Pharmacokinetic sampling - AZD9291, Dietary Fasted
- Where
- 13 sites in France, South Korea and 2 more
- Volunteers
- 38 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
Non Small Cell Lung Cancer
Study to Assess the Effect of Rifampicin on Blood Levels and Safety of AZD9291, 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
- NCT02197247
- Testing
- Pharmacokinetic sampling - AZD9291, Rifampicin, AZD9291 tablet dosing
- Where
- 18 sites in United States, Netherlands and 4 more
- Volunteers
- 41 people
- Sponsor
- AstraZeneca
Non-squamous, Non-Small Cell Lung Cancer
The Study Observes How Long Patients With Non-small Cell Lung Cancer (NSCLC) Benefit From Treatment With Epidermal Growth Factor Tyrosine Kinase Inhibitor (EGFR-TKI) When Given Either for Uncommon Mutations or for Common Mutations in the Sequence Afatinib Followed by Osimertinib
Non-interventional, multi-country, multi-centre cohort study based on existing data from medical records (paper or electronic) or electronic health records of patients with advanced NSCLC harbouring EGFR mutations and treated…
- Trial name
- UpSwinG (NCT04179890)
- Testing
- Afatinib (Gi(l)otrif®), Erlotinib (Tarceva®), Gefitinib (IRESSA®)
- Where
- United Kingdom
- Volunteers
- 462 people
- Sponsor
- Boehringer Ingelheim
Lung Cancer
Osimertinib Plus Chemotherapy in Uncommon EGFRm NSCLC
This is an open-label, single-arm, multicenter, exploratory Phase II study sponsored by Astrazeneca Investment (China) Co., LTD.
- Trial name
- MINOVA (NCT05215951)
- Testing
- osimertinib
- Where
- 6 sites in China
- Volunteers
- 4 people
- Sponsor
- AstraZeneca
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
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
Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV)
Immune-Modulated Study of Selected Small Molecules (Gefitinib, AZD9291, or Selumetinib + Docetaxel) or a 1st Immune-Mediated Therapy (IMT; Tremelimumab) With a Sequential Switch to a 2nd IMT (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
Primary objective: To assess the efficacy of various sequences of either a small molecule or an IMT (IMT-A) followed by a IMT-B (MEDI4736) .
- Trial name
- NCT02179671
- Testing
- Gefitinib, AZD9291, Selumetinib+Docetaxel
- Where
- 10 sites in United States
- Volunteers
- 32 people
- 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
Carcinoma, Non-Small-Cell Lung, Lung Cancer
G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer
This was a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with osimertinib in patients with EGFR mutation-positive metastatic non-small cell lung cancer.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Lung Cancer, Non-small Cell Lung Cancer
- Trial name
- NCT03455829
- Testing
- G1T38, Osimertinib
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- G1 Therapeutics, Inc.
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
Carcinoma, Non-Small-Cell Lung
Afatinib Osimertinib Sequencing NIS
This is a non-interventional, multi-country, multi-centre cohort study based on existing data from medical records of patients with EGFR mutation-positive advanced NSCLC treated with afatinib (Gi(l)otrif®) as the first-line…
- Trial name
- NCT03370770
- Testing
- Afatinib, Osimertinib
- Where
- Austria
- Volunteers
- 204 people
- Sponsor
- Boehringer Ingelheim
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
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)