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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 as adjuvant therapy after resection in patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion or L858R, as first-line therapy in patients with metastatic NSCLC harboring EGFR exon 19 deletion or L858R, in patients with locally advanced non-resectable NSCLC harboring EGFR exon 19 deletion or L858R who did not progress on chemoradiation, in combination with pemetrexed and platinum-based chemotherapy as first-line therapy in patients with locally advanced or metastatic NSCLC harboring EGFR 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).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Osimertinib Tagrisso AZD9291 EGFR Inhibitor 3rd gen 26 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 EGFR exon 19 deletion or L858R, as first-line therapy in patients with metastatic NSCLC harboring EGFR exon 19 deletion or L858R, in patients with locally advanced non-resectable NSCLC harboring EGFR exon 19 deletion or L858R who did not progress on chemoradiation, in combination with pemetrexed and platinum-based chemotherapy as first-line therapy in patients with locally advanced or metastatic NSCLC harboring EGFR 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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF G469V lung adenocarcinoma sensitive Osimertinib Preclinical - Pdx & cell culture Actionable In a preclinical study, Tagrisso (osimertinib) treatment inhibited viability of cells derived from a patient-derived xenograft (PDX) model of lung adenocarcinoma harboring BRAF G469V in culture and led to inhibition of tumor growth in a patient-derived xenograft (PDX) model (PMID: 34648945). 34648945
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...
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 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
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
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
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
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
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
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
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
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
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
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...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03865511 Phase II Osimertinib MEchanisms of Resistance in EGFR Mutated Nonpretreated Advanced Lung Cancer Receiving OSimErtib (MELROSE) Active, not recruiting FRA 0
NCT06350097 Phase III Osimertinib Datopotamab deruxtecan + Osimertinib Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer (TROPION-Lung14) Recruiting USA | POL | ITA | ESP | DEU | CAN | BRA | AUS 7
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 | SWE | NLD | ITA | HUN | GBR | FRA | ESP | DEU | CAN | AUS 7
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 | TUR | SWE | ROU | POL | NLD | ITA | ISR | HUN | FRA | ESP | DEU | CAN | BRA | BEL | AUS 9
NCT05493501 Phase III Aumolertinib + Cisplatin + Pemetrexed Disodium Aumolertinib + Carboplatin + Pemetrexed Disodium Aumolertinib + Carboplatin + Paclitaxel Aumolertinib + Cisplatin + Paclitaxel Aumolertinib + Cisplatin + Nab-paclitaxel Aumolertinib + Carboplatin + Nab-paclitaxel Aumolertinib + Cisplatin + Gemcitabine Aumolertinib Aumolertinib + Carboplatin + Gemcitabine Osimertinib Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer Terminated USA 0
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 | TUR | SWE | ROU | POL | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BGR | BEL | AUS 11
NCT02451852 Phase I Osimertinib AZD9291 US Expanded Access Program No longer available USA 0
NCT03497767 Phase II Osimertinib A Randomised Phase II Trial of Osimertinib With or Without SRS for EGFR Mutated NSCLC With Brain Metastases (OUTRUN) Completed AUS 1
NCT02474355 Phase III Osimertinib Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC Completed SWE | ITA | IRL | GBR | ESP | DNK | CAN | BRA | BEL | AUT | AUS | ARG 4
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 | NLD | GBR | ESP 2
NCT06630325 Phase II Fulvestrant Olaparib + Pegylated liposomal doxorubicin Abemaciclib + Letrozole Abemaciclib Olaparib Olaparib + Temozolomide Abemaciclib + Tamoxifen Abemaciclib + Gemcitabine Gefitinib Abemaciclib + Pemetrexed Disodium Abemaciclib + Exemestane Osimertinib Carboplatin + Gefitinib + Pemetrexed Disodium Carboplatin + Olaparib + Paclitaxel A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced, Recurrent Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer Not yet recruiting USA 0
NCT03586453 Phase II Osimertinib Osimertinib In EGFR Mutant Lung Cancer Active, not recruiting USA 0
NCT05526755 Phase II Osimertinib A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC) (TARGET) Active, not recruiting USA | ITA | GBR | ESP 7
NCT04233021 Phase II Osimertinib Study of Osimertinib in Patients With a Lung Cancer With Brain or Leptomeningeal Metastases With EGFR Mutation (ORBITAL) Active, not recruiting FRA 0
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) Active, not recruiting USA | TUR | POL | ITA | ISR | GBR | FRA | ESP | DEU | CHE | CAN | BRA | BGR | AUT 11
NCT01802632 Phase Ib/II Osimertinib AZD9291 First Time In Patients Ascending Dose Study (AURA) Completed USA | ITA | GBR | FRA | ESP | DEU | AUS 3
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 | AUS 2
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
NCT04811001 Phase II Dacomitinib Osimertinib Best EGFR-TKI Sequence in NSCLC Harboring EGFR Mutations (CAPLAND) Recruiting ITA 0
NCT04410796 Phase II Carboplatin + Osimertinib + Pemetrexed Disodium Osimertinib Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers Recruiting USA 0
NCT06014827 Phase II Osimertinib Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) With Osimertinib for the Treatment of Patients With Oligoprogressive EGFR Positive Non-small Cell Lung Carcinoma Recruiting USA 0
NCT02759835 Phase II Osimertinib Local Ablative Therapy for Treatment of Oligoprogressive, EGFR-Mutated, Non-Small Cell Lung Cancer After Treatment With Osimertinib Completed USA 0
NCT03433469 Phase II Osimertinib Osimertinib in Treating Participants With Stage I-IIIA EGFR-mutant Non-small Cell Lung Cancer Before Surgery 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 Completed GBR | FRA | ESP 1
NCT03810066 Phase II Osimertinib Exploring the Theragnostic Value of Osimertinib in EGFR-mutated Lung Cancer (THEROS) Completed DEU 0
NCT04181060 Phase III Osimertinib Bevacizumab + Osimertinib Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer Recruiting USA 0
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 Completed USA | FRA | ESP | BEL 1
NCT06486142 Phase III Osimertinib Afatinib Dacomitinib EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study (ERIS) Recruiting SWE 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) Active, not recruiting USA 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 (CAURAL) Completed CAN 2
NCT03434418 Phase II Osimertinib A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations Completed 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, NORTHSTAR Study Active, not recruiting USA 0
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) Active, not recruiting USA | TUR | POL | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | ARG 12
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
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 Active, not recruiting DEU 0
NCT03239340 Phase III Osimertinib A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib (ELIOS) Completed USA | ITA | ESP 2
NCT03667820 Phase II Osimertinib Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC Active, not recruiting USA 0
NCT03769103 Phase II Osimertinib Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC Active, not recruiting CAN 0
NCT05298176 Phase II Afatinib Afatinib + Carboplatin + Pemetrexed Disodium Carboplatin + Osimertinib + Pemetrexed Disodium Osimertinib Combining Afatinib and Concurrent Chemotherapy, Followed by Osimertinib and Concurrent Chemotherapy, in Untreated EGFR Positive NSCLC Tumors (COMBINATION) Recruiting NLD 0
NCT05785208 FDA approved Osimertinib Efficacy Study of Osimertinib in Treatment-naïve Patients With EGFR Mutant NSCLC According to TP53 Mutational Status. (TEMPLE-2) Recruiting ITA 0
NCT05120349 Phase III Osimertinib A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection (ADAURA2) Active, not recruiting USA | TUR | ROU | POL | ITA | GBR | ESP | DEU | CAN | BRA | ARG 9
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 Completed USA 0
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 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 | GBR | FRA | ESP 0
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
NCT03535363 Phase I Osimertinib Osimertinib With Stereotactic Radiosurgery (SRS) in Brain Metastases From EGFR Positive NSCLC Completed USA 0
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) Active, not recruiting USA | TUR | HUN | ESP | BRA | ARG 11
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) Completed USA | NLD | GBR | BEL 2
NCT06194448 Phase II Carboplatin + Pemetrexed Disodium Osimertinib Carboplatin + Paclitaxel Cisplatin + Paclitaxel Cisplatin + Pemetrexed Disodium To Evaluate the Efficacy/Safety of Osimertinib Prior to CRT and Maintenance of it With Stage III, Unresectable NSCLC With EGFR Mutations (NEOLA) Recruiting USA | TUR | ISR | ESP 6
NCT04908956 Phase II Osimertinib Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR Mutant NSCLC (STEREO) (STEREO) Terminated SWE | POL | NLD | ITA | ESP | CHE 2
NCT05089916 Phase II Osimertinib Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study (ROSE) Recruiting DEU 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) Active, not recruiting USA | SVK | GBR | FRA | CZE | CAN | BRA | AUS | ARG 12
NCT03732352 Phase II Osimertinib 18F-FDG PET and Osimertinib in Evaluating Glucose Utilization in Patients With EGFR Activated Recurrent Glioblastoma Completed 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 | GBR | FRA | ESP | BEL 1


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