Therapy Detail

Therapy Name Osimertinib
Therapy Description

Tagrisso (osimertinib) is a third-generation EGFR inhibitor that selectively binds mutant forms of the EGF receptor, inhibiting downstream signaling and potentially reducing cell proliferation and growth in EGFR overexpressing tumors (NCI Drug Dictionary). Tagrisso (osimertinib) is FDA-approved for use in patients with non-small cell lung cancer harboring EGFR exon 19 deletions, L858R, or T790M (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Osimertinib Tagrisso AZD9291 EGFR Inhibitor 3rd gen 15 Tagrisso (osimertinib) is a third-generation EGFR inhibitor that selectively binds mutant forms of the EGF receptor, inhibiting downstream signaling and potentially reducing cell proliferation and growth in EGFR overexpressing tumors (NCI Drug Dictionary). Tagrisso (osimertinib) is FDA-approved for use in patients with non-small cell lung cancer harboring EGFR exon 19 deletions, L858R, or T790M (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 G776delinsVC Advanced Solid Tumor sensitive Osimertinib Preclinical - Cell culture Actionable In a preclinical study, Tagrisso (osimertinib) inhibited growth of transformed cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 30527195). 30527195
MET amp non-small cell lung carcinoma predicted - resistant Osimertinib Clinical Study Actionable In a clinical case study, a patient with non-small cell lung cancer harboring EGFR amplification and EGFR T790M progressed after Tagrisso (osimertinib) treatment, and was found to have lost the EGFR mutations and acquired a MET amplification (PMID: 30268451). 30268451
MET amp non-small cell lung carcinoma predicted - resistant Osimertinib Clinical Study Actionable In a clinical case study, two patients with non-small cell lung cancer harboring EGFR T790M progressed after Tagrisso (osimertinib) treatment, and was found to have lost EGFR T790M and acquired MET amplification (PMID: 30268451). 30268451
ERBB2 G776delinsVC ERBB2 C805S Advanced Solid Tumor resistant Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC and an acquired ERBB2 (HER2) C805S were resistant to Tagrisso (osimertinib) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup Advanced Solid Tumor resistant Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) were resistant to Tagrisso (osimertinib) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup ERBB2 C805S Advanced Solid Tumor resistant Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) and an acquired ERBB2 (HER2) C805S were resistant to Tagrisso (osimertinib) in culture (PMID: 30527195). 30527195
KRAS mutant non-small cell lung carcinoma no benefit Osimertinib Guideline Actionable KRAS mutations are associated with lack of efficacy with EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) in patients with non-small cell lung cancer (NCCN.org). detail...
ERBB2 wild-type Advanced Solid Tumor sensitive Osimertinib Preclinical Actionable In a preclinical study, Tagrisso (osimertinib) treatment resulted in antitumor efficacy in cells overexpressing wild-type ERBB2 (HER2), demonstrating inhibition of ERBB2 (HER2) phosphorylation and cell growth in culture and tumor regression in mouse models overexpressing wild-type ERBB2, with an 80% reduction in tumor volume (PMID: 29298799). 29298799
ROS1 rearrange non-small cell lung carcinoma no benefit Osimertinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ROS1 rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
ERBB2 G778_P780dup Advanced Solid Tumor decreased response Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) demonstrated decreased response to Tagrisso (osimertinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ALK rearrange non-small cell lung carcinoma no benefit Osimertinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ALK rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
Clinical Trial Phase Therapies Title Recruitment Status
NCT02157883 Phase I Itraconazole Osimertinib 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) Active, not recruiting
NCT01802632 Phase Ib/II Osimertinib AZD9291 First Time In Patients Ascending Dose Study Active, not recruiting
NCT03410043 Phase II Osimertinib Trial of Local Consolidation Therapy (LCT) After Osimertinib for Patients With EGFR Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC) Recruiting
NCT02179671 Phase II Selumetinib + Docetaxel Gefitinib Durvalumab Osimertinib Tremelimumab 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 Completed
NCT02465060 Phase II Dabrafenib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Binimetinib Adavosertib Osimertinib Trastuzumab Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib trastuzumab emtansine Larotrectinib Pertuzumab Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting
NCT02474355 Phase III Osimertinib Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC Active, not recruiting
NCT03239340 Phase III Osimertinib A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib Recruiting
NCT02511106 Phase III Osimertinib AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy Recruiting
NCT02163733 Phase I Osimertinib 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 Active, not recruiting
NCT02496663 Phase I Necitumumab Osimertinib EGFR Inhibitor AZD9291 and Necitumumab in Treating Patients With EGFR-Positive Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor Recruiting
NCT02759835 Phase II Osimertinib Local Ablative Therapy for Treatment of Oligoprogressive, EGFR-Mutated, Non-Small Cell Lung Cancer After Treatment With Osimertinib Recruiting
NCT02197234 Phase I Osimertinib + Simvastatin Osimertinib Study to Assess the Effect of AZD9291 on the Blood Levels of Simvastatin in Patients With EGFRm+ NSCLC Active, not recruiting
NCT03434418 Phase II Osimertinib A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations Recruiting
NCT02228369 Phase I Osimertinib AZD3759 Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors, AZD3759 or AZD9291, in Patients Who Have Advanced Non-Small Cell Lung Cancer Active, not recruiting
NCT02161770 Phase I Osimertinib Study to Assess the Blood Levels and Safety of AZD9291 in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment Completed
NCT03191149 Phase II Osimertinib Osimertinib in Treating Patients With Stage IIIB-IV or Recurrent Non-small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations Recruiting
NCT02296125 Phase III Erlotinib Osimertinib Gefitinib AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Active, not recruiting
NCT02971501 Phase II Osimertinib Bevacizumab + Osimertinib Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases Recruiting
NCT02451852 Phase I Osimertinib AZD9291 US Expanded Access Program No longer available
NCT03667820 Phase II Osimertinib Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC Recruiting
NCT03433469 Phase II Osimertinib Osimertinib in Treating Participants With Stage I-IIIA EGFR-mutant Non-small Cell Lung Cancer Before Surgery Recruiting
NCT02151981 Phase III Osimertinib AZD9291 Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Active, not recruiting
NCT03455829 Phase Ib/II Osimertinib G1T38 + Osimertinib G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer Recruiting
NCT03521154 Phase III Osimertinib A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA) (LAURA) Recruiting
NCT03535363 Phase I Osimertinib Osimertinib With Stereotactic Radiosurgery (SRS) in Brain Metastases From EGFR Positive NSCLC Recruiting
NCT02197247 Phase I Osimertinib + Rifampin Osimertinib Study to Assess the Effect of Rifampicin on Blood Levels and Safety of AZD9291, in Patients With EGFRm+ NSCLC Active, not recruiting
NCT03586453 Phase II Osimertinib Osimertinib In EGFR Mutant Lung Cancer Recruiting
NCT02317016 Phase I Osimertinib Rosuvastatin Study to Assess the Effect of AZD9291 on the Blood Levels of Rosuvastatin, in Patients With EGFRm+ Non-small Cell Lung Cancer Completed
NCT02454933 Phase III Osimertinib Durvalumab Study of AZD9291 Plus MEDI4736 Versus AZD9291 Monotherapy in NSCLC After Previous EGFR TKI Therapy in T790M Mutation Positive Tumours Active, not recruiting
NCT03732352 Phase II Osimertinib 18F-FDG PET and Osimertinib in Evaluating Glucose Utilization in Patients With EGFR Activated Recurrent Glioblastoma Not yet recruiting