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

Versions (1)
  1. 07/06/2016 07/06/2016 -
Téléchargé le

7 juin 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer (NSCLC) NCT02352948

Anglais

Eligibility Non-Small Cell Lung Cancer (NSCLC) NCT02352948

1 Formulaires  
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
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Similar models

Eligibility Non-Small Cell Lung Cancer (NSCLC) NCT02352948

1 Formulaires
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])
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