0 Évaluations

ID

15658

Description

A Global Study to Assess the Effects of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02352948

Lien

https://clinicaltrials.gov/show/NCT02352948

Mots-clés

  1. 07/06/2016 07/06/2016 -
Téléchargé le

7 juin 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :


    Aucun commentaire

    Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

    Eligibility Non-Small Cell Lung Cancer (NSCLC) NCT02352948

    Eligibility Non-Small Cell Lung Cancer (NSCLC) NCT02352948

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    aged at least 18 years
    Description

    Age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    documented evidence of nsclc (stage iiib/ iv disease)
    Description

    Non-Small Cell Lung Carcinoma

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0007131
    disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional regimen for treatment of nsclc
    Description

    Disease Progression | Disease recurrence | Chemotherapy Regimen Platinum-Based | Chemotherapy Regimen Non-Small Cell Lung Carcinoma

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0242656
    UMLS CUI [2]
    C0679254
    UMLS CUI [3,1]
    C0392920
    UMLS CUI [3,2]
    C1514162
    UMLS CUI [4,1]
    C0392920
    UMLS CUI [4,2]
    C0007131
    world health organization (who) performance status of 0 or 1
    Description

    WHO performance status scale

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1298650
    estimated life expectancy more than 12 weeks
    Description

    Life Expectancy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    prior exposure to any anti-pd-1 or anti-pd-l1 antibody or anti ctla4
    Description

    Exposure to Programmed Cell Death Protein 1 Antibodies | Exposure to Antigens, CD274 Antibodies | Exposure to cytotoxic T-lymphocyte antigen 4 Antibodies

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0332157
    UMLS CUI [1,2]
    C2986635
    UMLS CUI [1,3]
    C0003241
    UMLS CUI [2,1]
    C0332157
    UMLS CUI [2,2]
    C3203086
    UMLS CUI [2,3]
    C0003241
    UMLS CUI [3,1]
    C0332157
    UMLS CUI [3,2]
    C0111208
    UMLS CUI [3,3]
    C0003241
    brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
    Description

    Metastatic malignant neoplasm to brain | Compression of spinal cord | Metastatic malignant neoplasm to brain Asymptomatic | Metastatic malignant neoplasm to brain Treated | Metastatic malignant neoplasm to brain Stable status | Compression of spinal cord Asymptomatic | Compression of spinal cord Treated | Compression of spinal cord Stable status | Steroids

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0220650
    UMLS CUI [2]
    C0037926
    UMLS CUI [3,1]
    C0220650
    UMLS CUI [3,2]
    C0231221
    UMLS CUI [4,1]
    C0220650
    UMLS CUI [4,2]
    C1522326
    UMLS CUI [5,1]
    C0220650
    UMLS CUI [5,2]
    C0205360
    UMLS CUI [6,1]
    C0037926
    UMLS CUI [6,2]
    C0231221
    UMLS CUI [7,1]
    C0037926
    UMLS CUI [7,2]
    C1522326
    UMLS CUI [8,1]
    C0037926
    UMLS CUI [8,2]
    C0205360
    UMLS CUI [9]
    C0038317
    active or prior documented autoimmune disease within the past 2 years
    Description

    Autoimmune Diseases

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0004364
    evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis b, c and hiv
    Description

    severe systemic disease | Systemic disease Uncontrolled | Hemorrhagic Disorders | Infection | Hepatitis B | Hepatitis C | HIV

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0973444
    UMLS CUI [2,1]
    C0442893
    UMLS CUI [2,2]
    C0205318
    UMLS CUI [3]
    C0019087
    UMLS CUI [4]
    C3714514
    UMLS CUI [5]
    C0019163
    UMLS CUI [6]
    C0019196
    UMLS CUI [7]
    C0019682
    any unresolved toxicity ctcae (common terminology criteria of adverse events) >grade 2 from previous anti-cancer therapy
    Description

    Toxic effect Unresolved | CTCAE | cancer treatment

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0600688
    UMLS CUI [1,2]
    C0443342
    UMLS CUI [2]
    C1516728
    UMLS CUI [3]
    C0920425
    known egfr tk activating mutations or alk rearrangements
    Description

    Mutation Activating Epidermal growth factor receptor inhibitor | ALK gene Rearrangement

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0026882
    UMLS CUI [1,2]
    C1879547
    UMLS CUI [1,3]
    C1443775
    UMLS CUI [2,1]
    C1332080
    UMLS CUI [2,2]
    C0017287
    any prior grade ≥3 immune-related adverse event (irae) while receiving any previous immunotherapy agent, or any unresolved irae >grade 1
    Description

    Adverse event Immune system | Immunotherapy Pharmaceutical Preparations | Immune system Adverse event Unresolved

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0020962
    UMLS CUI [2,1]
    C0021083
    UMLS CUI [2,2]
    C0013227
    UMLS CUI [3,1]
    C0020962
    UMLS CUI [3,2]
    C0877248
    UMLS CUI [3,3]
    C0443342
    active or prior documented inflammatory bowel disease (eg, crohn's disease, ulcerative colitis)
    Description

    Inflammatory Bowel Diseases | Crohn Disease | Ulcerative Colitis

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2]
    C0010346
    UMLS CUI [3]
    C0009324

    Similar models

    Eligibility Non-Small Cell Lung Cancer (NSCLC) NCT02352948

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    aged at least 18 years
    boolean
    C0001779 (UMLS CUI [1])
    Non-Small Cell Lung Carcinoma
    Item
    documented evidence of nsclc (stage iiib/ iv disease)
    boolean
    C0007131 (UMLS CUI [1])
    Disease Progression | Disease recurrence | Chemotherapy Regimen Platinum-Based | Chemotherapy Regimen Non-Small Cell Lung Carcinoma
    Item
    disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional regimen for treatment of nsclc
    boolean
    C0242656 (UMLS CUI [1])
    C0679254 (UMLS CUI [2])
    C0392920 (UMLS CUI [3,1])
    C1514162 (UMLS CUI [3,2])
    C0392920 (UMLS CUI [4,1])
    C0007131 (UMLS CUI [4,2])
    WHO performance status scale
    Item
    world health organization (who) performance status of 0 or 1
    boolean
    C1298650 (UMLS CUI [1])
    Life Expectancy
    Item
    estimated life expectancy more than 12 weeks
    boolean
    C0023671 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Exposure to Programmed Cell Death Protein 1 Antibodies | Exposure to Antigens, CD274 Antibodies | Exposure to cytotoxic T-lymphocyte antigen 4 Antibodies
    Item
    prior exposure to any anti-pd-1 or anti-pd-l1 antibody or anti ctla4
    boolean
    C0332157 (UMLS CUI [1,1])
    C2986635 (UMLS CUI [1,2])
    C0003241 (UMLS CUI [1,3])
    C0332157 (UMLS CUI [2,1])
    C3203086 (UMLS CUI [2,2])
    C0003241 (UMLS CUI [2,3])
    C0332157 (UMLS CUI [3,1])
    C0111208 (UMLS CUI [3,2])
    C0003241 (UMLS CUI [3,3])
    Metastatic malignant neoplasm to brain | Compression of spinal cord | Metastatic malignant neoplasm to brain Asymptomatic | Metastatic malignant neoplasm to brain Treated | Metastatic malignant neoplasm to brain Stable status | Compression of spinal cord Asymptomatic | Compression of spinal cord Treated | Compression of spinal cord Stable status | Steroids
    Item
    brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
    boolean
    C0220650 (UMLS CUI [1])
    C0037926 (UMLS CUI [2])
    C0220650 (UMLS CUI [3,1])
    C0231221 (UMLS CUI [3,2])
    C0220650 (UMLS CUI [4,1])
    C1522326 (UMLS CUI [4,2])
    C0220650 (UMLS CUI [5,1])
    C0205360 (UMLS CUI [5,2])
    C0037926 (UMLS CUI [6,1])
    C0231221 (UMLS CUI [6,2])
    C0037926 (UMLS CUI [7,1])
    C1522326 (UMLS CUI [7,2])
    C0037926 (UMLS CUI [8,1])
    C0205360 (UMLS CUI [8,2])
    C0038317 (UMLS CUI [9])
    Autoimmune Diseases
    Item
    active or prior documented autoimmune disease within the past 2 years
    boolean
    C0004364 (UMLS CUI [1])
    severe systemic disease | Systemic disease Uncontrolled | Hemorrhagic Disorders | Infection | Hepatitis B | Hepatitis C | HIV
    Item
    evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis b, c and hiv
    boolean
    C0973444 (UMLS CUI [1])
    C0442893 (UMLS CUI [2,1])
    C0205318 (UMLS CUI [2,2])
    C0019087 (UMLS CUI [3])
    C3714514 (UMLS CUI [4])
    C0019163 (UMLS CUI [5])
    C0019196 (UMLS CUI [6])
    C0019682 (UMLS CUI [7])
    Toxic effect Unresolved | CTCAE | cancer treatment
    Item
    any unresolved toxicity ctcae (common terminology criteria of adverse events) >grade 2 from previous anti-cancer therapy
    boolean
    C0600688 (UMLS CUI [1,1])
    C0443342 (UMLS CUI [1,2])
    C1516728 (UMLS CUI [2])
    C0920425 (UMLS CUI [3])
    Mutation Activating Epidermal growth factor receptor inhibitor | ALK gene Rearrangement
    Item
    known egfr tk activating mutations or alk rearrangements
    boolean
    C0026882 (UMLS CUI [1,1])
    C1879547 (UMLS CUI [1,2])
    C1443775 (UMLS CUI [1,3])
    C1332080 (UMLS CUI [2,1])
    C0017287 (UMLS CUI [2,2])
    Adverse event Immune system | Immunotherapy Pharmaceutical Preparations | Immune system Adverse event Unresolved
    Item
    any prior grade ≥3 immune-related adverse event (irae) while receiving any previous immunotherapy agent, or any unresolved irae >grade 1
    boolean
    C0877248 (UMLS CUI [1,1])
    C0020962 (UMLS CUI [1,2])
    C0021083 (UMLS CUI [2,1])
    C0013227 (UMLS CUI [2,2])
    C0020962 (UMLS CUI [3,1])
    C0877248 (UMLS CUI [3,2])
    C0443342 (UMLS CUI [3,3])
    Inflammatory Bowel Diseases | Crohn Disease | Ulcerative Colitis
    Item
    active or prior documented inflammatory bowel disease (eg, crohn's disease, ulcerative colitis)
    boolean
    C0021390 (UMLS CUI [1])
    C0010346 (UMLS CUI [2])
    C0009324 (UMLS CUI [3])

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial