Therapy Detail

Contact

Missing content? – Request curation!

Request curation for specific Genes, variants, or PubMed publications.

Have questions, comments or suggestions? - Let us know!

Email us at : ckbsupport@jax.org

Therapy Name Osimertinib
Synonyms
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 (PMID: 29151359). 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).

Filtering

  • Case insensitive filtering will display rows where any text in any cell matches the filter term
  • Simple literal full or partial string matches
  • Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page, filtering has no impact on query parameters
  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

Sorting

  • Generally, the default sort order for tables is set to be first column ascending, however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column, be sure to set ascending or descending order for a given column, before moving on to the next column.

Drug Name Trade Name Synonyms Drug Classes Drug Description
Osimertinib Tagrisso AZD9291 EGFR Inhibitor 3rd gen 21 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 (PMID: 29151359). Tagrisso (osimertinib) is FDA-approved for use as adjuvant therapy after resection in patients with non-small cell lung cancer (NSCLC) harboring EFGFR exon 19 deletion or L858R, as first-line therapy in patients with metastatic NSCLC harboring EFGFR exon 19 deletion or L858R, and for treatment in patients with metastatic NSCLC harboring EGFR T790M whose disease progressed after EGFR TKI therapy (FDA.gov).

Filtering

  • Case insensitive filtering will display rows where any text in any cell matches the filter term
  • Simple literal full or partial string matches
  • Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page, filtering has no impact on query parameters
  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

Sorting

  • Generally, the default sort order for tables is set to be first column ascending, however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column, be sure to set ascending or descending order for a given column, before moving on to the next column.

Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PIK3CA act mut lung non-small cell carcinoma predicted - resistant Osimertinib Case Reports/Case Series Actionable In a retrospective analysis, activating PIK3CA mutations were identified in 6 of 100 patients with non-small cell lung cancer at treatment discontinuation of Tagrisso (osimertinib) (PMID: 31839416). 31839416
CTNNB1 T41I lung non-small cell carcinoma predicted - resistant Osimertinib Case Reports/Case Series Actionable In a retrospective analysis, activating CTNNB1 mutations including S37F/C (n=5), D32V (n=1), G34V (n=1), and T41I (n=1) were identified in 8 of 100 patients with non-small cell lung cancer at treatment discontinuation of Tagrisso (osimertinib) (PMID: 31839416). 31839416
ROS1 rearrange lung non-small cell 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...
CTNNB1 S37C lung non-small cell carcinoma predicted - resistant Osimertinib Case Reports/Case Series Actionable In a retrospective analysis, activating CTNNB1 mutations including S37F/C (n=5), D32V (n=1), G34V (n=1), and T41I (n=1) were identified in 8 of 100 patients with non-small cell lung cancer at treatment discontinuation of Tagrisso (osimertinib) (PMID: 31839416). 31839416
ALK rearrange lung non-small cell 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...
NRAS act mut lung non-small cell carcinoma predicted - resistant Osimertinib Case Reports/Case Series Actionable In a retrospective analysis, activating NRAS mutations were identified in 1 of 100 patients with non-small cell lung cancer at treatment discontinuation of Tagrisso (osimertinib) (PMID: 31839416). 31839416
CTNNB1 act mut lung non-small cell carcinoma predicted - resistant Osimertinib Case Reports/Case Series Actionable In a retrospective analysis, activating CTNNB1 mutations including S37F/C (n=5), D32V (n=1), G34V (n=1), and T41I (n=1) were identified in 8 of 100 patients with non-small cell lung cancer at treatment discontinuation of Tagrisso (osimertinib) (PMID: 31839416). 31839416
PTEN inact mut lung non-small cell carcinoma predicted - resistant Osimertinib Case Reports/Case Series Actionable In a retrospective analysis, inactivating PTEN mutations were identified in 3 of 100 patients with non-small cell lung cancer at treatment discontinuation of Tagrisso (osimertinib) (PMID: 31839416). 31839416
CTNNB1 D32V lung non-small cell carcinoma predicted - resistant Osimertinib Case Reports/Case Series Actionable In a retrospective analysis, activating CTNNB1 mutations including S37F/C (n=5), D32V (n=1), G34V (n=1), and T41I (n=1) were identified in 8 of 100 patients with non-small cell lung cancer at treatment discontinuation of Tagrisso (osimertinib) (PMID: 31839416). 31839416
CTNNB1 S37F lung non-small cell carcinoma predicted - resistant Osimertinib Case Reports/Case Series Actionable In a retrospective analysis, activating CTNNB1 mutations including S37F/C (n=5), D32V (n=1), G34V (n=1), and T41I (n=1) were identified in 8 of 100 patients with non-small cell lung cancer at treatment discontinuation of Tagrisso (osimertinib) (PMID: 31839416). 31839416
CTNNB1 G34V lung non-small cell carcinoma predicted - resistant Osimertinib Case Reports/Case Series Actionable In a retrospective analysis, activating CTNNB1 mutations including S37F/C (n=5), D32V (n=1), G34V (n=1), and T41I (n=1) were identified in 8 of 100 patients with non-small cell lung cancer at treatment discontinuation of Tagrisso (osimertinib) (PMID: 31839416). 31839416
TP53 inact mut lung non-small cell carcinoma not predictive Osimertinib Clinical Study - Cohort Actionable In a retrospective analysis, patients with non-small cell lung cancer harboring inactivating TP53 mutations at treatment discontinuation of Tagrisso (osimertinib) had shorter time to treatment discontinuation (5 vs 11.5 months, p=0.0005) compared to patients with wild-type TP53 (PMID: 31839416). 31839416
BRAF act mut lung non-small cell carcinoma predicted - resistant Osimertinib Case Reports/Case Series Actionable In a retrospective analysis, activating BRAF mutations were identified in 4 of 100 patients with non-small cell lung cancer at treatment discontinuation of Tagrisso (osimertinib) (PMID: 31839416). 31839416
TP53 mutant lung non-small cell carcinoma not predictive Osimertinib Clinical Study - Cohort Actionable In a retrospective analysis, patients with non-small cell lung cancer harboring TP53 mutations at treatment discontinuation of Tagrisso (osimertinib) had shorter time to treatment discontinuation (6.5 vs 11.5 months, p=0.0029) compared to patients with wild-type TP53 (PMID: 31839416). 31839416

Filtering

  • Case insensitive filtering will display rows where any text in any cell matches the filter term
  • Simple literal full or partial string matches
  • Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page, filtering has no impact on query parameters
  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

Sorting

  • Generally, the default sort order for tables is set to be first column ascending, however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column, be sure to set ascending or descending order for a given column, before moving on to the next column.

Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02296125 Phase III Erlotinib Osimertinib Gefitinib AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA) Active, not recruiting USA | CAN 28
NCT04351555 Phase III Cisplatin + Pemetrexed Disodium Cisplatin + Osimertinib + Pemetrexed Disodium Carboplatin + Osimertinib + Pemetrexed Disodium Osimertinib Carboplatin + Pemetrexed Disodium 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 (NeoADAURA) Recruiting USA 22
NCT03732352 Phase II Osimertinib 18F-FDG PET and Osimertinib in Evaluating Glucose Utilization in Patients With EGFR Activated Recurrent Glioblastoma Active, not recruiting USA 0
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 4
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 USA 16
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 Active, not recruiting USA 0
NCT04233021 Phase II Osimertinib Study of Osimertinib in Patients With a Lung Cancer With Brain or Leptomeningeal Metastases With EGFR Mutation (ORBITAL) Recruiting 1
NCT03434418 Phase II Osimertinib A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations Recruiting USA 0
NCT03909334 Phase II Osimertinib + Ramucirumab Osimertinib Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Recruiting USA 0
NCT02157883 Phase I Osimertinib 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 USA 5
NCT01802632 Phase Ib/II Osimertinib AZD9291 First Time In Patients Ascending Dose Study Active, not recruiting USA 9
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 Suspended USA 0
NCT04035486 Phase III Osimertinib Carboplatin + Osimertinib + Pemetrexed Disodium Cisplatin + Osimertinib + Pemetrexed Disodium Osimertinib + Pemetrexed Disodium 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) (FLAURA2) Recruiting USA | CAN 19
NCT02474355 Phase III Osimertinib Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC Completed CAN 16
NCT02197234 Phase I Osimertinib + Simvastatin Simvastatin Osimertinib Study to Assess the Effect of AZD9291 on the Blood Levels of Simvastatin in Patients With EGFRm+ NSCLC Active, not recruiting USA 4
NCT04811001 Phase II Dacomitinib Osimertinib Best EGFR-TKI Sequence in NSCLC Harboring EGFR Mutations (CAPLAND) Recruiting 1
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. (ADAURA) Active, not recruiting USA | CAN 23
NCT03810066 Phase II Osimertinib Exploring the Theragnostic Value of Osimertinib in EGFR-mutated Lung Cancer (THEROS) Recruiting 1
NCT04181060 Phase III Osimertinib Bevacizumab + Osimertinib AZD9291 (Osimertinib) With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer Recruiting USA 0
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 USA 5
NCT03586453 Phase II Osimertinib Osimertinib In EGFR Mutant Lung Cancer Recruiting USA 0
NCT03410043 Phase II Osimertinib Osimertinib, Surgery, and Radiation Therapy in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer With EGFR Mutations Recruiting USA 0
NCT03769103 Phase II Osimertinib Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC Recruiting CAN 0
NCT04486833 Phase Ib/II Osimertinib + Quaratusugene Ozeplasmid Osimertinib TUSC2-nanoparticles (GPX-001) and Osimertinib in Patients With Stage IV Lung Cancer Who Progressed on Osimertinib Alone (Acclaim-1) Recruiting USA 0
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 (BLOOM) Completed USA 3
NCT02179671 Phase II Docetaxel + Selumetinib 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 USA 0
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 USA 3
NCT02151981 Phase III Carboplatin + Pemetrexed Disodium Cisplatin + Pemetrexed Disodium Osimertinib AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (AURA3) Active, not recruiting USA | CAN 16
NCT04487080 Phase III amivantamab-vmjw + Lazertinib Lazertinib Osimertinib A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA) Recruiting USA | CAN 26
NCT03667820 Phase II Osimertinib Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC Recruiting USA 0
NCT04335292 Phase II Cisplatin + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium Osimertinib Osimertinib Then Chemotherapy in EGFR-mutated Lung Cancer With Osimertinib Third-line Rechallenge (OCELOT) Recruiting CAN 0
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 CAN 2
NCT02465060 Phase II Erdafitinib Copanlisib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Pertuzumab + Trastuzumab Dabrafenib + Trametinib Binimetinib Adavosertib Osimertinib Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Larotrectinib Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting USA 2
NCT04413201 FDA approved Afatinib + Osimertinib Osimertinib AFAMOSI: Efficacy and Safety of Afatinib Followed by Osimertinib Compared to Osimertinib in Patients With EGFRmutated/T790M Mutation Negative Nonsquamous NSCLC Recruiting 1
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 Completed USA 5
NCT02451852 Phase I Osimertinib AZD9291 US Expanded Access Program No longer available USA 0
NCT04908956 Phase II Osimertinib Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR Mutant NSCLC (STEREO) (STEREO) Not yet recruiting 7
NCT02759835 Phase II Osimertinib Local Ablative Therapy for Treatment of Oligoprogressive, EGFR-Mutated, Non-Small Cell Lung Cancer After Treatment With Osimertinib Active, not recruiting USA 0
NCT04410796 Phase II Carboplatin + Osimertinib + Pemetrexed Disodium Osimertinib Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers Recruiting USA 0
NCT03239340 Phase III Osimertinib A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib Active, not recruiting USA 4
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 Active, not recruiting USA 0
NCT03535363 Phase I Osimertinib Osimertinib With Stereotactic Radiosurgery (SRS) in Brain Metastases From EGFR Positive NSCLC Active, not recruiting USA 0
NCT03433469 Phase II Osimertinib Osimertinib in Treating Participants With Stage I-IIIA EGFR-mutant Non-small Cell Lung Cancer Before Surgery Recruiting USA 0


Additional content available in CKB BOOST