Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Osimertinib

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44349   clinical trials with a EudraCT protocol, of which   7376   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    69 result(s) found for: Osimertinib. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2018-004290-28 Sponsor Protocol Number: NA Start Date*: 2019-07-03
    Sponsor Name:
    Full Title: Pharmacokinetic boosting of osimertinib in patients with non-small cell lung cancer.
    Medical condition: Non-small cell lung carcinoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-003012-51 Sponsor Protocol Number: D5084C00007 Start Date*: 2019-05-15
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase II Study Assessing the Efficacy of Osimertinib in Combination with Savolitinib in Patients with EGFRm+ and MET+, Locally Advanced or Metastatic Non Small Cell Lung Cancer who have Progresse...
    Medical condition: EGFRm+ and MET+, Locally Advanced or Metastatic Non Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029515 Non-small cell lung cancer recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) ES (Ongoing) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-003677-21 Sponsor Protocol Number: CINC280L12301 Start Date*: 2021-09-10
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase III randomized, controlled, open-label, multicenter, global study of capmatinib in combination with osimertinib versus platinum - pemetrexed based doublet chemotherapy in patients with loca...
    Medical condition: EGFR mutated, T790M negative NSCLC
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) DE (Completed) ES (Prematurely Ended) SI (Prematurely Ended) PL (Prematurely Ended) IT (Prematurely Ended) BG (Prematurely Ended) HU (Prematurely Ended) HR (Completed)
    Trial results: View results
    EudraCT Number: 2019-002197-31 Sponsor Protocol Number: AFAMOSI Start Date*: 2020-05-12
    Sponsor Name:Universitätsmedizin Mainz, Interdisziplinäres Zentrum klinische Studien
    Full Title: AFAMOSI: Prospective, randomized, multicenter Phase IV study to evaluate the efficacy and safety of afatinib followed by osimertinib compared to osimertinib in patients with EGFRmutated/T790M Mutat...
    Medical condition: EGFR mutated non-squamous NSCLC
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10038666 Respiratory and mediastinal neoplasms malignant and unspecified HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-004135-89 Sponsor Protocol Number: D516FC00001 Start Date*: 2022-04-07
    Sponsor Name:AstraZeneca AB
    Full Title: Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to Assess the Efficacy and Safety of Adjuvant Osimertinib versus Placebo in Participants with EGFR mutation positive Sta...
    Medical condition: Stage IA2-IA3 non-small cell lung carcinoma, with EGFR mutation type (Ex19del, L858R), following complete tumour resection.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029517 Non-small cell lung cancer stage I PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Ongoing) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-001538-33 Sponsor Protocol Number: MS200095-0031 Start Date*: 2019-11-28
    Sponsor Name:Merck Healthcare KGaA
    Full Title: A Phase II, two arm study to investigate tepotinib combined with osimertinib in MET amplified, advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating EGFR mutations and havi...
    Medical condition: Locally advanced or metastatic NSCLC histology (confirmed by either histology or cytology) with documented activating mutation of the EGFR receptor including T790M status Resistance on previous fir...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Trial now transitioned) NL (Completed) BE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-003025-37 Sponsor Protocol Number: 2020AFA01 Start Date*: 2020-10-06
    Sponsor Name:VU University Medical Center
    Full Title: COMBINING AFATINIB AND CONCURRENT CHEMOTHERAPY, FOLLOWED BY OSIMERTINIB AND CONCURRENT CHEMOTHERAPY, IN UNTREATED EGFR POSITIVE NSCLC TUMORS
    Medical condition: non small cell lung cancer (NSCLC)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-001834-82 Sponsor Protocol Number: 1613-LCG Start Date*: 2017-10-09
    Sponsor Name:European Organisation for Research and Treatment of Cancer (EORTC)
    Full Title: APPLE trial: Feasibility and activity of AZD9291 (osimertinib) treatment on Positive PLasma T790M in EGFR mutant NSCLC patients
    Medical condition: NSCLC patients
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SI (Completed) ES (Ongoing) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-003460-24 Sponsor Protocol Number: 82914 Start Date*: 2023-02-23
    Sponsor Name:Radboud University Medical Center
    Full Title: Pilot study to determine the intraTUMORal OsImertinib concentration in patients with peritoneal metastasizeD colorectal cancer (TUMOROID study)
    Medical condition: Colorectal cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001061-16 Sponsor Protocol Number: D5160C00048 Start Date*: 2018-09-04
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III, randomized, double-blind, placebo-controlled, multicenter, international study of Osimertinib as maintenance therapy in patients with locally advanced, unresectable EGFR mutation-posit...
    Medical condition: Histologically documented non-small cell lung cancer of predominantly non-squamous pathology who present with locally advanced, unresectable (Stage III) disease, whose tumor tissue has EGFR exon 19...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029519 Non-small cell lung cancer stage III PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) HU (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-005121-21 Sponsor Protocol Number: THEROS Start Date*: 2018-11-13
    Sponsor Name:Universitätsklinikum Essen
    Full Title: Exploring the theragnostic value of osimertinib in EGFR-mutated lung cancer (THEROS) - A multicentric phase II study in patients with TKI-resistant EGFR-mutated lung cancer exhibiting early metabol...
    Medical condition: Non-small-cell lung cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2020-001879-33 Sponsor Protocol Number: ESR-18-13811 Start Date*: 2021-12-02
    Sponsor Name:FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    Full Title: Efficacy study of osimertinib in treatment-naïve patients with EGFR mutant NSCLC according to TP53 mutational status (TEMPLE-2)
    Medical condition: Patients with EGFR mutant NSCLC according to TP53 mutational status
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10051054 Lung disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-002805-23 Sponsor Protocol Number: IFCT-1804 Start Date*: 2020-01-07
    Sponsor Name:IFCT
    Full Title: A Phase II, multi-centre study, to evaluate the efficacy and safety of osimertinib treatment for patients with EGFR-mutated non-small cell lung cancer (NSCLC) with Brain or Leptomeningeal metasta...
    Medical condition: EGFR-mutated Non-small cell lung cancer (NSCLC) with Brain or Leptomeningeal metastases
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    22.0 10018065 - General disorders and administration site conditions 10071975 EGFR gene mutation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004734-28 Sponsor Protocol Number: ESR-16-12212 Start Date*: 2019-02-13
    Sponsor Name:University Medical Center Groningen
    Full Title: Patients on osimertinib with EGFR mutation exon 20, non-T790M in lung cancer. The position-20 trial.
    Medical condition: Patients on osimertinib with EGFR mutation exon 20, non-T790M in lung cancer. The position-20 trial.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-006374-24 Sponsor Protocol Number: D5087C00001 Start Date*: 2022-07-08
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated, MET-Overexpressed and/or Ampli...
    Medical condition: EGFR Mutated, MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10029514 Non-small cell lung cancer NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) PL (Trial now transitioned) GR (Trial now transitioned) AT (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003969-18 Sponsor Protocol Number: D5162C00042 Start Date*: 2021-07-21
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Pemetrexed Chemotherapy Plus Osimertinib Versus Platinum Plus Pemetrexed Chemotherapy Plus Placebo in Patients with ...
    Medical condition: Non-Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Completed) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-003218-42 Sponsor Protocol Number: RC18_0287 Start Date*: 2019-01-16
    Sponsor Name:CHU de Nantes
    Full Title: Phase 2 study evaluating MEchanisms of resistance on tumor tissue and Liquid biopsy in patients with EGFR mutated nonpretreated advanced Lung cancer Receiving OSimErtinib until and beyond radiologi...
    Medical condition: Locally advanced or metastatic Non-small-cell lung carcinoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002869-35 Sponsor Protocol Number: CAPLAND Start Date*: 2020-03-10
    Sponsor Name:FONDAZIONE RICERCA TRASLAZIONALE (FORT)
    Full Title: A randomized, non-comparative, phase II study investigating the best epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) sequence in advanced or metastatic non-small-cell lung can...
    Medical condition: Advanced or metastatic untreated EGFR mutation positive NSCLC
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-000650-61 Sponsor Protocol Number: D5169C00001 Start Date*: 2020-07-10
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III, Open-label, Randomized Study of Osimertinib with or without Platinum Plus Pemetrexed Chemotherapy, as First-line Treatment in Patients with Epidermal Growth Factor Receptor (EGFR) Muta...
    Medical condition: Patients with locally-advanced or metastatic EGFRm (Ex19del and/or L858R) Non-Small Cell Lung Cancer.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SK (Completed) FR (Trial now transitioned) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004757-88 Sponsor Protocol Number: PACE-LUNG Start Date*: 2021-09-22
    Sponsor Name:Goethe-Universität, vertreten durch den Präsidenten, dieser vertreten durch den LKP (bevollmächtigt durch den Sponsor)
    Full Title: Additional chemotherapy for EGFRm patients with the continued presence of plasma ctDNA EGFRm at week 3 after start of osimertinib 1st-line treatment
    Medical condition: Advanced NSCLC with common EGFR-Mutation
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  4  Next»
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Jul 13 06:34:09 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA