Osimertinib
Information
- Drug Name
- Osimertinib
- Description
- Entry(CIViC)
- 11
CIViC
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| Case report of a patient with stage IV lung adenoc... | EGFR |
EGFR p.Cys797Ser (p.C797S) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Cys797Ser (p.C797S) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| Case report of a patient with stage IV lung adenoc... | EGFR |
EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Osimertinib has been approved for the treatment of... | EGFR |
EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Randomized, international, open-label, phase 3 tri... | EGFR |
EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| In a lung adenocarcinoma patient harboring an EGFR... | EGFR |
EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Evidence of wild-type allele-mediated resistance, ... | EGFR |
EGFR AMPLIFICATION ( ENST00000275493.7 ) EGFR AMPLIFICATION ( ENST00000275493.7 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| Cell line, xenograft, and transgenic models were u... | EGFR |
EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| An EGFR resistance mutation, C797S, was discovered... | EGFR |
EGFR p.Cys797Ser (p.C797S) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Cys797Ser (p.C797S) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| This phase I/II trial (NCT01802632) involved 253 n... | EGFR |
EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| This study summarized 9 EGFR-mutant patients from ... | EGFR |
EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| For cell harboring EGFR T790M mutation, osimertini... | EGFR |
EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT02971501 | Active, not recruiting | Phase 2 | Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases | June 27, 2018 | July 1, 2024 |
| NCT04862780 | Active, not recruiting | Phase 1/Phase 2 | (SYMPHONY) Phase 1/2 Study Targeting EGFR Resistance Mechanisms in NSCLC | June 29, 2021 | January 31, 2025 |
| NCT04721015 | Active, not recruiting | Phase 1 | Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors | February 23, 2021 | August 30, 2024 |
| NCT04545710 | Active, not recruiting | Phase 2 | Osimertinib and Abemaciclib in EGFR Mutant Non-Small Cell Lung Cancer After Osimertinib Resistance | November 21, 2020 | December 1, 2023 |
| NCT05629234 | Active, not recruiting | Phase 3 | Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib (TAGRISSO) (ROSY-T) | May 8, 2023 | February 21, 2025 |
| NCT03804580 | Active, not recruiting | Phase 2 | First-line Treatment With Osimertinib in EGFR-mutated Non-small Cell Lung Cancer | December 1, 2018 | December 31, 2025 |
| NCT03122717 | Active, not recruiting | Phase 1/Phase 2 | Osimertinib and Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer | May 9, 2017 | April 2026 |
| NCT03810807 | Active, not recruiting | Phase 1 | Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer | January 17, 2019 | January 2025 |
| NCT03831932 | Active, not recruiting | Phase 1/Phase 2 | Telaglenastat Hydrochloride and Osimertinib in Treating Patients With EGFR-Mutated Stage IV Non-small Cell Lung Cancer | March 16, 2020 | June 1, 2025 |
| NCT02411448 | Active, not recruiting | Phase 3 | A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY) | May 6, 2015 | December 16, 2024 |
| NCT04487080 | Active, not recruiting | Phase 3 | A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer | September 30, 2020 | June 9, 2027 |
| NCT03909334 | Active, not recruiting | Phase 2 | Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) | July 25, 2019 | June 2024 |
| NCT03940703 | Active, not recruiting | Phase 2 | A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2) | September 19, 2019 | May 27, 2024 |
| NCT03944772 | Active, not recruiting | Phase 2 | Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) | June 25, 2019 | May 6, 2025 |
| NCT04035486 | Active, not recruiting | Phase 3 | 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) | July 2, 2019 | June 3, 2026 |
| NCT04413201 | Active, not recruiting | Phase 4 | AFAMOSI: Efficacy and Safety of Afatinib Followed by Osimertinib Compared to Osimertinib in Patients With EGFRmutated/T790M Mutation Negative Nonsquamous NSCLC | September 11, 2020 | June 30, 2024 |
| NCT04141644 | Active, not recruiting | Phase 1 | Safety and Efficacy of Combination Osimertinib and Ipilimumab in Patients w EGFR Mutated NSCLC | August 20, 2020 | April 30, 2028 |
| NCT04391283 | Active, not recruiting | First Line Osimertinib for EGFR Mutation-positive Non-Small Cell Lung Cancer in Real World Chinese Setting | July 27, 2020 | December 2024 | |
| NCT04285671 | Active, not recruiting | Phase 1/Phase 2 | Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer | January 29, 2021 | December 2, 2026 |
| NCT04233021 | Active, not recruiting | Phase 2 | Study of Osimertinib in Patients With a Lung Cancer With Brain or Leptomeningeal Metastases With EGFR Mutation | July 16, 2020 | February 2024 |
| NCT03133546 | Active, not recruiting | Phase 2 | Osimertinib and Bevacizumab Versus Osimertinib Alone as Second-line Treatment in Stage IIIb-IVb NSCLC With Confirmed EGFRm and T790M (BOOSTER) | May 31, 2017 | May 2023 |
| NCT05228015 | Active, not recruiting | Phase 1 | Oral TEAD Inhibitor Targeting the Hippo Pathway in Subjects With Advanced Solid Tumors | January 7, 2022 | June 2025 |
| NCT02465060 | Active, not recruiting | Phase 2 | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) | August 17, 2015 | December 31, 2025 |
| NCT02496663 | Active, not recruiting | Phase 1 | Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor | May 11, 2016 | June 30, 2025 |
| NCT05163249 | Active, not recruiting | Phase 2 | Osimertinib With or Without Savolitinib as 1L in de Novo MET+, EGFR+ NSCLC | May 31, 2022 | August 2026 |
| NCT02503722 | Active, not recruiting | Phase 1 | Testing the Combination of MLN0128 (TAK-228) and AZD9291 in Advanced EGFR (Epidermal Growth Factor Receptor) Mutation Positive Non-small Cell Lung Cancer | March 23, 2017 | June 29, 2024 |
| NCT03381274 | Active, not recruiting | Phase 1/Phase 2 | Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study | May 8, 2018 | July 15, 2025 |
| NCT03392246 | Active, not recruiting | Phase 2 | A Phase 2 Study of Osimertinib in Combination With Selumetinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer | January 31, 2018 | June 30, 2026 |
| NCT02520778 | Active, not recruiting | Phase 1 | Osimertinib and Navitoclax in Treating Patients With EGFR-Positive Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer | August 30, 2016 | July 30, 2024 |
| NCT03410043 | Active, not recruiting | Phase 2 | Osimertinib, Surgery, and Radiation Therapy in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer With EGFR Mutations, NORTHSTAR Study | January 17, 2018 | June 1, 2025 |
| NCT03433469 | Active, not recruiting | Phase 2 | Osimertinib in Treating Participants With Stage I-IIIA EGFR-mutant Non-small Cell Lung Cancer Before Surgery | July 31, 2018 | October 31, 2026 |
| NCT02856893 | Active, not recruiting | Phase 2 | Osimertinib Treatment on EGFR T790M Plasma Positive NSCLC Patients (APPLE) | October 10, 2017 | December 2027 |
| NCT02917993 | Active, not recruiting | Phase 1/Phase 2 | An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer | December 20, 2016 | December 31, 2025 |
| NCT06303167 | Active, not recruiting | Phase 2 | Testing AZD9291 as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH-Subprotocol E) | January 8, 2016 | December 31, 2025 |
| NCT02099058 | Active, not recruiting | Phase 1 | A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors | January 15, 2014 | November 16, 2024 |
| NCT05103605 | Active, not recruiting | Prospective Cohort of Locally Advanced and Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations | May 12, 2021 | January 15, 2026 | |
| NCT02664935 | Active, not recruiting | Phase 2 | National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer | May 2015 | September 2024 |
| NCT05017025 | Active, not recruiting | Phase 1/Phase 2 | Aurora Kinase Inhibitor LY3295668 in Combination With Osimertinib for the Treatment of Advanced or Metastatic EGFR-Mutant Non-squamous Non-small Cell Lung Cancer | February 17, 2022 | June 30, 2025 |
| NCT03567642 | Active, not recruiting | Phase 1 | A Study of the Combination of Osimertinib, Platinum and Etoposide for Patients With Metastatic EGFR Mutant Lung Cancers | June 12, 2018 | June 2024 |
| NCT04908956 | Active, not recruiting | Phase 2 | Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR Mutant NSCLC (STEREO) | August 4, 2022 | March 2026 |
| NCT03667820 | Active, not recruiting | Phase 2 | Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC | September 26, 2018 | April 1, 2025 |
| NCT03732352 | Active, not recruiting | Phase 2 | 18F-FDG PET and Osimertinib in Evaluating Glucose Utilization in Patients With EGFR Activated Recurrent Glioblastoma | November 28, 2018 | October 1, 2025 |
| NCT03497767 | Completed | Phase 2 | A Randomised Phase II Trial of Osimertinib With or Without SRS for EGFR Mutated NSCLC With Brain Metastases | August 15, 2019 | April 30, 2024 |
| NCT02759835 | Completed | Phase 2 | Local Ablative Therapy for Treatment of Oligoprogressive, EGFR-Mutated, Non-Small Cell Lung Cancer After Treatment With Osimertinib | April 13, 2016 | September 20, 2022 |
| NCT02769286 | Completed | Phase 2 | Osimertinib in First and Second Line Treatment of NSCLC Harboring EGFR Mutations From Circulating Tumor DNA | August 2016 | May 2020 |
| NCT02789345 | Completed | Phase 1 | A Study of Ramucirumab (LY3009806) or Necitumumab (LY3012211) Plus Osimertinib in Participants With Lung Cancer | October 24, 2016 | May 9, 2022 |
| NCT02803203 | Completed | Phase 1/Phase 2 | Osimertinib and Bevacizumab as Treatment for EGFR-mutant Lung Cancers | June 29, 2016 | March 1, 2022 |
| NCT02841579 | Completed | Phase 2 | Osimertinib (AZD9291) in First-line Locally Advanced or Metastatic NSCLC Patients With EGFR and EGFR T790M | August 2016 | February 2020 |
| NCT02959749 | Completed | Phase 2/Phase 3 | Osimertinib or Docetaxel-bevacizumab as Third-line Treatment in EGFR T790M Mutated Non-Small Cell Lung Cancer | August 2015 | December 31, 2017 |
| NCT03133234 | Completed | Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC | May 23, 2017 | September 13, 2017 | |
| NCT03219970 | Completed | Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting. | September 5, 2017 | October 28, 2020 | |
| NCT03239340 | Completed | Phase 2 | A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib | May 30, 2018 | September 19, 2023 |
| NCT03370770 | Completed | Afatinib Osimertinib Sequencing NIS | December 28, 2017 | November 28, 2019 | |
| NCT03394118 | Completed | Phase 2 | TAGRISSO (Osimertinib) in NSCLC Patients in Whom T790 Mutations Are Detected by Liquid Biopsy | August 11, 2017 | April 8, 2021 |
| NCT03434418 | Completed | Phase 2 | A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations | June 30, 2018 | October 12, 2022 |
| NCT03455829 | Completed | Phase 1/Phase 2 | G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer | March 29, 2018 | February 14, 2022 |
| NCT03463525 | Completed | Phase 1 | Open-label PET Study With [11C]Osimertinib in Patients With EGFRm NSCLC and Brain Metastases | October 24, 2018 | October 5, 2020 |
| NCT03535363 | Completed | Phase 1 | Osimertinib With Stereotactic Radiosurgery (SRS) in Brain Metastases From EGFR Positive NSCLC | October 26, 2018 | April 1, 2022 |
| NCT03755102 | Completed | Early Phase 1 | A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib. | November 21, 2018 | July 7, 2023 |
| NCT03790397 | Completed | Osimertinib in Subjects With Advanced Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive | February 26, 2019 | April 1, 2020 | |
| NCT03810066 | Completed | Phase 2 | Exploring the Theragnostic Value of Osimertinib in EGFR-mutated Lung Cancer (THEROS) | June 3, 2019 | September 30, 2022 |
| NCT03853551 | Completed | Phase 4 | Osimertinib Study in Indian Patients | April 18, 2019 | April 15, 2020 |
| NCT04479306 | Completed | Phase 1 | Osimertinib in Combination With Alisertib or Sapanisertib for the Treatment of Osimertinib-Resistant EGFR Mutant Stage IIIB or IV Non-Small Cell Lung Cancer | June 18, 2020 | July 27, 2023 |
| NCT04959981 | Completed | Phase 1 | A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC | September 2, 2021 | April 27, 2023 |
| NCT06323148 | Not yet recruiting | Phase 3 | Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022) | April 1, 2024 | March 31, 2029 |
| NCT06417814 | Not yet recruiting | Phase 3 | A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer | August 12, 2024 | February 8, 2028 |
| NCT06067776 | Not yet recruiting | Phase 1 | Osimertinib, Cetuximab, and Tucatinib for the Treatment of EGFR-Mutant Stage IV or Recurrent Non-small Lung Cell Cancer | January 1, 2024 | November 1, 2026 |
| NCT06362980 | Not yet recruiting | Phase 1 | A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations | April 1, 2024 | April 1, 2026 |
| NCT06436144 | Not yet recruiting | Phase 2 | Osimertinib and Etoposide as First-Line Treatment in Osimertinib-Resistant Advanced EGFR-Mutant NSCLC | June 2024 | December 2029 |
| NCT04988607 | Not yet recruiting | Phase 2 | Osimertinib Plus Bevacizumab in Untreated EGFR Exon21 L858R Mutated NSCLC | August 2021 | May 2025 |
| NCT06319950 | Not yet recruiting | Phase 2 | High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases | April 1, 2024 | December 30, 2026 |
| NCT06018688 | Not yet recruiting | Phase 2 | Osimertinib Combined With Aspirin Neoadjuvant Therapy for Resectable EGFR Mutated NSCLC Patients. | September 15, 2023 | September 1, 2026 |
| NCT06093503 | Not yet recruiting | Phase 3 | Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met Protein | May 31, 2024 | April 11, 2028 |
| NCT06206850 | Not yet recruiting | Phase 2 | Neo-Bio-ADAURA: A Phase II Study to Evaluate Mechanisms of Resistance to Neoadjuvant Osimertinib | January 2024 | January 2030 |
| NCT05513664 | Not yet recruiting | Real-World Effectiveness of Osimertinib for Patients With Non-Small Cell Lung Cancer | September 2022 | August 2023 | |
| NCT06142617 | Not yet recruiting | Phase 2 | A Prospective Study of Pembrolizumab Combining Chemotherapy in Advanced NSCLC Patients With EGFR Exon 21 Point Mutation. | December 1, 2023 | June 30, 2028 |
| NCT05498389 | Not yet recruiting | Phase 1/Phase 2 | EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer | June 2023 | December 2024 |
| NCT04811001 | Recruiting | Phase 2 | Best EGFR-TKI Sequence in NSCLC Harboring EGFR Mutations | June 12, 2020 | December 31, 2023 |
| NCT04816838 | Recruiting | N/A | A Window of Opportunity Study for Investigating Drug Tolerant Persister (DTP) to Neoadjuvant Osimertinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harbouring EGFR Mutations | May 10, 2021 | October 2025 |
| NCT04829019 | Recruiting | Phase 2 | Neurocognition in NSCLC Patients Treated With Osimertinib or Osimertinib + WBI | April 7, 2021 | October 31, 2025 |
| NCT03769103 | Recruiting | Phase 2 | Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC | March 19, 2019 | April 2025 |
| NCT04868877 | Recruiting | Phase 1/Phase 2 | A Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors | April 28, 2021 | April 2025 |
| NCT03586453 | Recruiting | Phase 2 | Osimertinib In EGFR Mutant Lung Cancer | August 13, 2018 | March 1, 2026 |
| NCT05011487 | Recruiting | Phase 2 | Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC | August 13, 2021 | September 2028 |
| NCT05020769 | Recruiting | Phase 2/Phase 3 | SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer. | January 6, 2022 | June 1, 2024 |
| NCT05089916 | Recruiting | Phase 2 | Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study | January 20, 2022 | December 2026 |
| NCT05120349 | Recruiting | Phase 3 | A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection | February 21, 2022 | November 1, 2032 |
| NCT04322890 | Recruiting | Phase 2 | Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation | April 16, 2020 | December 24, 2027 |
| NCT04410796 | Recruiting | Phase 2 | Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers | May 28, 2020 | May 2025 |
| NCT04085315 | Recruiting | Phase 1 | Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer | November 12, 2019 | December 31, 2026 |
| NCT04486833 | Recruiting | Phase 1/Phase 2 | Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib | September 3, 2021 | December 2027 |
| NCT04676477 | Recruiting | Phase 1 | HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer | June 11, 2021 | February 1, 2026 |
| NCT04720976 | Recruiting | Phase 1/Phase 2 | JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors | March 23, 2021 | February 5, 2024 |
| NCT03778229 | Recruiting | Phase 2 | Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib | January 9, 2019 | May 28, 2025 |
| NCT04743505 | Recruiting | Phase 1/Phase 2 | Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) | January 18, 2022 | September 30, 2029 |
| NCT04762199 | Recruiting | Phase 1 | MRX-2843 and Osimertinib for the Treatment of Advanced EGFR Mutant Non-small Cell Lung Cancer | February 24, 2021 | December 27, 2026 |
| NCT04769388 | Recruiting | Phase 2 | Osimertinib Plus Chemotherapy vs Osimertinib in EGFRm NSCLC With Persistence Week-3 ctDNA EGFRm After 1L Osimertinib | December 28, 2021 | September 2024 |
| NCT04770688 | Recruiting | Phase 1/Phase 2 | Advanced Lung Tumor Treated by Osimertinib Plus Anlotinib | November 19, 2020 | November 30, 2025 |
| NCT04772235 | Recruiting | Phase 1 | Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients | February 11, 2022 | June 2026 |
| NCT04780568 | Recruiting | Phase 1 | Osimertinib and Tegavivint as First-Line Therapy for the Treatment of Metastatic EGFR-Mutant Non-small Cell Lung Cancer | January 18, 2022 | December 31, 2024 |
| NCT05686434 | Recruiting | Phase 2 | Osimertinib Therapy After Resection in High-risk Stage I EGFRm NSCLC (OSTAR) | October 14, 2022 | October 14, 2029 |
| NCT05785208 | Recruiting | Phase 4 | Efficacy Study of Osimertinib in Treatment-naïve Patients With EGFR Mutant NSCLC According to TP53 Mutational Status. | June 28, 2022 | October 31, 2025 |
| NCT05801029 | Recruiting | Phase 2 | A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth Factor Receptor Mutations | July 18, 2023 | April 30, 2028 |
| NCT05816252 | Recruiting | Phase 2 | A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) | April 19, 2023 | April 12, 2026 |
| NCT05834348 | Recruiting | A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway. | June 26, 2023 | February 3, 2025 | |
| NCT05948813 | Recruiting | Phase 2 | TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases | August 17, 2023 | December 30, 2027 |
| NCT05954871 | Recruiting | Phase 1 | Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Participants With Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer, or With Cetuximab in Participants With Metastatic Colorectal Cancer | January 8, 2024 | December 31, 2026 |
| NCT06014827 | Recruiting | Phase 2 | 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 | June 25, 2024 | July 11, 2026 |
| NCT06032936 | Recruiting | Phase 1 | BBP-398 in Combination With Osimertinib in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutations | July 27, 2023 | July 2026 |
| NCT06194448 | Recruiting | Phase 2 | To Evaluate the Efficacy/Safety of Osimertinib Prior to CRT and Maintenance of it With Stage III, Unresectable NSCLC With EGFR Mutations | April 21, 2024 | March 31, 2028 |
| NCT06304441 | Recruiting | N/A | Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer | March 2024 | March 2026 |
| NCT06350097 | Recruiting | Phase 3 | 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 | April 29, 2024 | May 25, 2032 |
| NCT06383728 | Recruiting | Phase 2 | Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma | April 1, 2024 | April 30, 2029 |
| NCT04181060 | Recruiting | Phase 3 | Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer | December 28, 2020 | December 31, 2026 |
| NCT04351555 | Recruiting | Phase 3 | 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 | December 16, 2020 | June 13, 2029 |
| NCT05166616 | Recruiting | Phase 1 | Minnelide and Osimertinib for the Treatment of Advanced EGFR Mutated Non-Small Cell Lung Cancer | March 7, 2022 | December 15, 2024 |
| NCT03191149 | Recruiting | Phase 2 | Osimertinib in Treating Patients With Stage IIIB-IV or Recurrent Non-small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations | April 25, 2018 | June 30, 2025 |
| NCT05261399 | Recruiting | Phase 3 | Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment | August 3, 2022 | December 17, 2026 |
| NCT05281406 | Recruiting | Phase 2 | Additional Chemotherapy for EGFRm Patients With the Continued Presence of Plasma ctDNA EGFRm at Week 3 After Start of Osimertinib 1st-line Treatment (PACE-LUNG) | November 12, 2021 | November 2026 |
| NCT05382728 | Recruiting | Phase 3 | Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO) | June 8, 2022 | December 2027 |
| NCT05401110 | Recruiting | Phase 1 | Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer | September 15, 2023 | January 2026 |
| NCT05458726 | Recruiting | Phase 2 | Correlation Between Efficacy of Osimertinib and EGFR T790M Status and Ratio Via ddPCR in NSCLC | September 15, 2020 | October 31, 2022 |
| NCT05507606 | Recruiting | Phase 2 | Study of Osimertinib+Bevacizumab+Chemotherapy for EGFR+ Advanced Non-Small Cell Lung Cancer With Concurrent Mutations | August 1, 2021 | August 1, 2024 |
| NCT05546866 | Recruiting | Phase 2 | Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in NSCLC With Uncommon EGFRm | February 21, 2023 | June 30, 2029 |
| NCT03040973 | Recruiting | Phase 2 | Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone | July 4, 2017 | July 30, 2027 |
| NCT05642572 | Recruiting | Phase 2 | Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial) | May 5, 2023 | May 31, 2027 |
| NCT05647122 | Recruiting | Phase 1 | First in Human Study of AZD9592 in Solid Tumors | December 22, 2022 | October 29, 2025 |
| NCT05421936 | Suspended | Osimertinib for NSCLC With Uncommon EGFR Mutations | September 27, 2020 | September 2024 | |
| NCT05215951 | Terminated | Phase 2 | Osimertinib Plus Chemotherapy in Uncommon EGFRm NSCLC | July 6, 2022 | March 9, 2023 |
| NCT03255083 | Terminated | Phase 1 | DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer | April 10, 2019 | September 4, 2020 |
| NCT04816214 | Terminated | Phase 3 | Study Evaluating Efficacy and Safety of Capmatinib in Combination With Osimertinib in Adult Subjects With Non-small Cell Lung Cancers as Second Line Therapy | September 22, 2021 | December 27, 2022 |
| NCT05153408 | Terminated | Phase 1 | (HARMONY) Study of BLU-701 in EGFR-mutant NSCLC | January 13, 2022 | December 9, 2022 |
| NCT03784599 | Terminated | Phase 2 | T-DM1 and Osimertinib Combination Treatment to Target HER2 Bypass Track Resistance in EGFR Mutation Positive NSCLC | December 18, 2018 | May 17, 2021 |
| NCT04870190 | Unknown status | Phase 3 | Almonertinib Versus Osimertinib in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases | June 1, 2021 | June 1, 2024 |
| NCT03532698 | Unknown status | Combination of Osimertinib and Aspirin to Treat Osimertinib Resistance Non-small Cell Lung Cancer ( NSCLC) | August 1, 2020 | December 31, 2022 | |
| NCT04148898 | Unknown status | Phase 2 | Osimertinib With or Without Bevacizumab for EGFR- Mutant Non-small Cell Lung Cancer With Leptomeningeal Metastasis | November 1, 2019 | July 1, 2021 |
| NCT04575415 | Unknown status | Bevacizumab Plus EGFR-TKIs in Chinese Patients With EGFR-mutant NSCLC: a Real-world Study | October 7, 2020 | December 2023 | |
| NCT02954523 | Unknown status | Phase 1/Phase 2 | Dasatinib and Osimertinib (AZD9291) in Advanced Non-Small Cell Lung Cancer With EGFR Mutations | October 2016 | June 2023 |
| NCT04425681 | Unknown status | Phase 2 | Osimertinib With Bevacizumab for Leptomeningeal Metastasis From EGFR-mutation Non-Small Cell Lung Cancer | October 1, 2017 | June 1, 2021 |
| NCT03543683 | Unknown status | Combination of Osimertinib and Aspirin to Treat 1st Generation EGFR-TKI Resistance in NSCLC | August 1, 2020 | December 31, 2022 | |
| NCT03891615 | Unknown status | Phase 1 | Niraparib in Combination With Osimertinib in EGFR-Mutated Advanced Lung Cancer | June 6, 2019 | April 30, 2024 |
| NCT05693090 | Withdrawn | Phase 1 | Tipifarnib and Osimertinib in EGFR-mutated Non-Small Cell Lung Cancer | February 1, 2023 | July 27, 2027 |
- Trade name (Drug list of Screening Committee of Anticancer Drugs)
- Tagrisso
- US Approved Year (20160209) (Drug list of Screening Committee of Anticancer Drugs)
- 2015
- Japan Approved Year (20160209) (Drug list of Screening Committee of Anticancer Drugs)
- 申請中
- Target (Drug list of Screening Committee of Anticancer Drugs)
- EGFR
- Disease name (Drug list of Screening Committee of Anticancer Drugs)
- 非小細胞肺がん (EGFR/T790M)