Therapy Detail
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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 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 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 |
|---|---|---|---|---|---|---|---|
| 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 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 |
| 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 |
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
|---|---|---|---|---|---|---|
| NCT02451852 | Phase I | Osimertinib | AZD9291 US Expanded Access Program | No longer available | 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 |
| 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 |
| 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) | Recruiting | USA | ITA | GBR | ESP | 7 |
| NCT04410796 | Phase II | Carboplatin + Osimertinib + Pemetrexed Disodium Osimertinib | Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers | Recruiting | 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) | Active, not recruiting | USA | GBR | FRA | CAN | AUS | 16 |
| 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 |
| 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 | NLD | ITA | FRA | ESP | DEU | CAN | BEL | AUS | 16 |
| 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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 9 |
| 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 |
| 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 |
| 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 | ITA | GBR | FRA | ESP | DEU | CAN | AUT | 18 |
| NCT03497767 | Phase II | Osimertinib | A Randomised Phase II Trial of Osimertinib With or Without SRS for EGFR Mutated NSCLC With Brain Metastases (OUTRUN) | Recruiting | AUS | 1 |
| NCT04181060 | Phase III | Osimertinib Bevacizumab + Osimertinib | Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer | Recruiting | 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 |
| 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 | ESP | 15 |
| 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 |
| NCT01802632 | Phase Ib/II | Osimertinib | AZD9291 First Time In Patients Ascending Dose Study (AURA) | Completed | USA | ITA | GBR | FRA | ESP | DEU | AUS | 3 |
| NCT02474355 | Phase III | Osimertinib | Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC | Completed | ITA | GBR | ESP | CAN | BEL | AUT | AUS | 9 |
| 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 |
| 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 |
| NCT04908956 | Phase II | Osimertinib | Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR Mutant NSCLC (STEREO) (STEREO) | Active, not recruiting | NLD | ITA | ESP | 5 |
| 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) | Not yet recruiting | USA | ESP | 8 |
| NCT03434418 | Phase II | Osimertinib | A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations | Completed | 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 |
| 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 |
| 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 |
| NCT03535363 | Phase I | Osimertinib | Osimertinib With Stereotactic Radiosurgery (SRS) in Brain Metastases From EGFR Positive NSCLC | Completed | USA | 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) | Recruiting | USA | ITA | GBR | ESP | DEU | CAN | 14 |
| 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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 18 |
| 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 |
| 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 |
| 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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 21 |
| 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 |
| 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 |
| NCT03810066 | Phase II | Osimertinib | Exploring the Theragnostic Value of Osimertinib in EGFR-mutated Lung Cancer (THEROS) | Completed | DEU | 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 |
| NCT03586453 | Phase II | Osimertinib | Osimertinib In EGFR Mutant Lung Cancer | 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 |
| NCT05089916 | Phase II | Osimertinib | Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study (ROSE) | Recruiting | DEU | 0 |
| 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 |
| NCT03667820 | Phase II | Osimertinib | Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC | Active, not recruiting | USA | 0 |
| NCT04811001 | Phase II | Dacomitinib Osimertinib | Best EGFR-TKI Sequence in NSCLC Harboring EGFR Mutations (CAPLAND) | Recruiting | ITA | 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 |
| 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 |
| 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 |
| 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) | Not yet recruiting | AUS | 3 |
| 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 |
| 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 |
| NCT03769103 | Phase II | Osimertinib | Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC | Recruiting | CAN | 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 | Active, not recruiting | USA | FRA | ESP | BEL | 1 |
| NCT03865511 | Phase II | Osimertinib | MEchanisms of Resistance in EGFR Mutated Nonpretreated Advanced Lung Cancer Receiving OSimErtib (MELROSE) | Active, not recruiting | FRA | 0 |
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