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Clinical trials for "companion diagnostic"

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   44413   clinical trials with a EudraCT protocol, of which   7422   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.
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    17 result(s) found for: "companion diagnostic". Displaying page 1 of 1.
    EudraCT Number: 2014-005060-15 Sponsor Protocol Number: EMR100070-004 Start Date*: 2015-06-23
    Sponsor Name:Merck KGaA
    Full Title: A Phase III open-label, multicenter trial of avelumab (MSB0010718C) versus docetaxel in subjects with non-small cell lung cancer that has progressed after a platinum-containing doublet
    Medical condition: Non-Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    19.0 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: SK (Completed) DE (Prematurely Ended) GB (Completed) BE (Completed) HU (Completed) DK (Completed) AT (Completed) ES (Completed) NL (Completed) FR (Completed) CZ (Completed) PL (Completed) HR (Completed) LV (Completed)
    Trial results: View results
    EudraCT Number: 2009-012293-12 Sponsor Protocol Number: NO25026 Start Date*: 2010-01-25
    Sponsor Name:F. Hoffmann-La Roche Ltd.
    Full Title: BRIM 3: A Randomized, Open-label, Controlled, Multicenter, Phase III Study in Previously untreated Patients with Unresectable Stage IIIC or Stage IV Melanoma with V600E BRAF mutation Receiving Vemu...
    Medical condition: First-line therapy for adult patients with histologically confirmed metastatic melanoma (unresectable Stage IIIC or Stage IV) harbouring the V600E positive mutation
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) FR (Completed) SE (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-005014-34 Sponsor Protocol Number: CLGX818A2202 Start Date*: 2014-05-15
    Sponsor Name:NOVARTIS FARMA S.p.A.
    Full Title: A phase II, single arm, open-label, multicenter, study of oral LGX818 in patients with BRAF V600 mutant advanced non-small cell lung cancer that have progressed during or after at least one prior c...
    Medical condition: Non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-001643-39 Sponsor Protocol Number: 2215-CL-0302 Start Date*: 2017-02-09
    Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
    Full Title: A Phase 2 Multicenter, Randomized, Double-Blind, Placebo- Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy...
    Medical condition: Subjects diagnosed with FLT3/ITD acute myeloid leukemia (AML) in CR1, including CRp and CRi, for whom a decision not to proceed with transplantation has been made, or a suitable donor could not be ...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) CZ (Completed) PL (Completed) PT (Completed) SE (Completed) GR (Completed) DK (Completed) HR (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-005542-38 Sponsor Protocol Number: MK-8931-019 Start Date*: 2014-03-17
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
    Full Title: A Phase III, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Clinical Trial to Study the Efficacy and Safety of MK-8931 (SCH 900931) in Subjects with Amnestic Mild Cognitive Impairment...
    Medical condition: prodromal Alzheimer's Disease
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004852 10001897 Alzheimer's disease (incl subtypes) HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Prematurely Ended) ES (Prematurely Ended) AT (Prematurely Ended) IT (Prematurely Ended) DE (Completed) GB (Prematurely Ended) FI (Completed) NL (Prematurely Ended) BE (Completed) HU (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-000091-11 Sponsor Protocol Number: PR200-102 Start Date*: 2021-09-21
    Sponsor Name:Prometheus Biosciences, Inc.
    Full Title: A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Activ...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) HU (Trial now transitioned) CZ (Trial now transitioned) PL (Trial now transitioned) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-000589-39 Sponsor Protocol Number: ADP-0044-002 Start Date*: 2020-02-13
    Sponsor Name:Adaptimmune LLC
    Full Title: A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T cells in subjects with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
    Medical condition: Advanced Synovial Sarcoma Myxoid/Round Cell Liposarcoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10042863 Synovial sarcoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073137 Myxoid liposarcoma PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073139 Round cell liposarcoma PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) GB (GB - no longer in EU/EEA) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000761-33 Sponsor Protocol Number: KB-ENTO-3001 Start Date*: 2022-01-03
    Sponsor Name:Kronos Bio, Inc.
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Entospletinib in Combination With Intensive Induction and Consolidation Chemotherapy in Adults Wit...
    Medical condition: Acute Myeloid Leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) ES (Prematurely Ended) HU (Prematurely Ended) CZ (Prematurely Ended) IT (Prematurely Ended) FR (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-000684-85 Sponsor Protocol Number: PR-30-5010-C Start Date*: 2014-01-14
    Sponsor Name:TESARO UK Limited, (c/o Sisec Limited) [...]
    1. TESARO UK Limited, (c/o Sisec Limited)
    2. TESARO Inc
    Full Title: A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician’s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer patients
    Medical condition: HER2 negative, BRCA germline mutated breast cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IS (Completed) HU (Completed) BE (Completed) GB (GB - no longer in EU/EEA) NL (Completed) ES (Ongoing) PT (Completed) IT (Completed) FR (Completed) PL (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2020-005802-24 Sponsor Protocol Number: ADP-0055-002 Start Date*: 2022-03-21
    Sponsor Name:Adaptimmune LLC
    Full Title: A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects with Advanced Esophageal or Esophagogastric Junction Cancers
    Medical condition: advanced esophageal or esophagogastric junction (EGJ) cancers
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10015362 Esophageal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-003315-35 Sponsor Protocol Number: B7461006 Start Date*: 2017-08-01
    Sponsor Name:Pfizer Inc,
    Full Title: A Phase 3, randomized, open-label study of lorlatinib (PF-06463922) monotherapy versus crizotinib monotherapy in the first-line treatment of patients with advanced ALK-positive non-small cell lung ...
    Medical condition: Advanced ALK positive 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) 10029522 Non-small cell lung cancer stage IV PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) DK (Prematurely Ended) CZ (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003126-25 Sponsor Protocol Number: DZ2019E0001 Start Date*: 2022-02-14
    Sponsor Name:Dizal (Jiangsu) Pharmaceutical Co., Ltd
    Full Title: A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) 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: ES (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-000685-11 Sponsor Protocol Number: PR-30-5011-C Start Date*: 2013-09-29
    Sponsor Name:TESARO Inc.
    Full Title: A Phase 3 Randomized Double-Blind Trial of Maintenance with Niraparib Versus Placebo in Patients with Platinum Sensitive Ovarian Cancer
    Medical condition: Platinum Sensitive Ovarian Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: SE (Completed) DE (Completed) AT (Completed) GB (GB - no longer in EU/EEA) DK (Completed) IT (Completed) HU (Completed) ES (Ongoing) BE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-000076-28 Sponsor Protocol Number: BO29554 Start Date*: 2017-08-25
    Sponsor Name:Roche Farma S.A (Soc.Unipersonal) que realiza el ensayo
    Full Title: A PHASE II/III MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE TARGETED THERAPIES AS TREATMENTS FOR PATIENTS WITH ADVANCED OR METASTATIC NON SMALL CELL LUNG CANCER (NSCLC) HARBORIN...
    Medical condition: Advanced or metastatic Non-small cell lung cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    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: ES (Ongoing) PL (Trial now transitioned) BE (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000189-45 Sponsor Protocol Number: Start Date*: 2018-03-26
    Sponsor Name:University of Padova
    Full Title: Adjuvant treatment for high-risk triple negative breast cancer patients with the anti-pd-l1 antibody Avelumab: A phase III randomized trial
    Medical condition: High risk triple negative (ER negative, PR negative, HER2 negative) breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000951-11 Sponsor Protocol Number: HR-BLTN-III-NSCLC Start Date*: 2020-10-14
    Sponsor Name:Jiangsu Hengrui Medicine Co., Ltd.
    Full Title: A Phase 3, Randomized , Open-Label, Multicenter Study of the Efficacy and Safety of Pyrotinib versus Docetaxel in Patients with Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Harboring a ...
    Medical condition: non-small cell lung cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) IT (Completed) FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-001551-13 Sponsor Protocol Number: D0818C00001 Start Date*: 2013-08-21
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients with BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer following ...
    Medical condition: BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
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    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.

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