ID

35141

Beskrivning

Ruxolitinib in Combination With Pemetrexed/Cisplatin in Non Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02119650

Länk

https://clinicaltrials.gov/show/NCT02119650

Nyckelord

Versioner (1)
  1. 2019-02-19 2019-02-19 -
Rättsinnehavare

See clinicaltrials.gov

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19 februari 2019

DOI

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Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT02119650

Engelsk

Eligibility Carcinoma, Non-Small-Cell Lung NCT02119650

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed diagnosis of nonsquamous nsclc that is stage iiib stage iv, or recurrent after prior definitive intervention (radiation, surgery, or chemoradiation therapy, with or without adjuvant or neoadjuvant chemotherapy).
Beskrivning

Non-squamous non-small cell lung cancer TNM clinical staging | Recurrent Non-Squamous Non-Small Cell Lung Carcinoma | Status post Intervention | Therapeutic radiology procedure | Operative Surgical Procedures | Chemoradiotherapy | Chemotherapy, Adjuvant | Chemotherapy Neoadjuvant | Adjuvant Chemotherapy Absent | Chemotherapy Neoadjuvant Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4324656
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C4288304
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0184661
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0543467
UMLS CUI [6]
C0436307
UMLS CUI [7]
C0085533
UMLS CUI [8,1]
C0392920
UMLS CUI [8,2]
C1298676
UMLS CUI [9,1]
C0085533
UMLS CUI [9,2]
C0332197
UMLS CUI [10,1]
C0392920
UMLS CUI [10,2]
C1298676
UMLS CUI [10,3]
C0332197
radiographically measurable or evaluable disease.
Beskrivning

Measurable Disease Radiography | Evaluable Disease Radiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0034571
UMLS CUI [2,1]
C1516986
UMLS CUI [2,2]
C0034571
life expectancy of at least 12 weeks.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
tumor without activating driver mutations for which there is available therapy (eg, tumor without mutations in epidermal growth factor receptor or anaplastic lymphoma).
Beskrivning

Neoplasms Without Mutation | Availability of Therapeutic procedure | EGFR Driver Mutation Negative | ALK gene mutation Negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0026882
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C0087111
UMLS CUI [3]
C4329758
UMLS CUI [4,1]
C2825843
UMLS CUI [4,2]
C1513916
an mgps of 1 or 2 as defined below:
Beskrivning

Score

Datatyp

boolean

Alias
UMLS CUI [1]
C0449820
*criteria:
Beskrivning

Criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0243161
c-reactive protein >10 mg/l and albumin ≥35 g/l; score = 1
Beskrivning

C-reactive protein measurement | Albumin measurement | Score

Datatyp

boolean

Alias
UMLS CUI [1]
C0201657
UMLS CUI [2]
C0201838
UMLS CUI [3]
C0449820
c-reactive protein >10 mg l and albumin <35 g/l; score = 2
Beskrivning

C-reactive protein measurement | Albumin measurement | Score

Datatyp

boolean

Alias
UMLS CUI [1]
C0201657
UMLS CUI [2]
C0201838
UMLS CUI [3]
C0449820
eastern cooperative oncology group (ecog) performance status of 0 to 1.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit.
Beskrivning

Renal function | Liver function | Bone Marrow function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
squamous or mixed histology (eg, adenosquamous) nsclc
Beskrivning

Squamous non-small cell lung cancer | Non-Small Cell Lung Carcinoma Adenosquamous

Datatyp

boolean

Alias
UMLS CUI [1]
C4509816
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0279557
previous systemic therapy for advanced or metastatic disease.
Beskrivning

Systemic therapy Advanced disease | Systemic therapy Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0679246
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0027627
known active central nervous system (cns) metastases.
Beskrivning

CNS metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval.
Beskrivning

Cancer Other | Exception Basal cell carcinoma Cured | Exception Squamous cell carcinoma of skin Cured | Exception Superficial carcinoma of urinary bladder | Exception Prostatic Intraepithelial Neoplasias | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm indolent

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1880198
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1336527
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0282612
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0851140
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0006826
UMLS CUI [7,3]
C0234227
current uncontrolled cardiac disease such as angina or myocardial infarction, congestive heart failure including new york heart association functional classification of 3, or arrhythmia requiring treatment.
Beskrivning

Heart Disease Uncontrolled | Angina Pectoris | Myocardial Infarction | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Treatment required for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C1275491
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0332121
uncontrolled concomitant medical conditions, including, but not limited to, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric diseases.
Beskrivning

Comorbidity Uncontrolled | Kidney Diseases | Liver diseases | Hematological Disease | Gastrointestinal Diseases | Endocrine System Diseases | Lung diseases | Nervous system disorder | Cerebral disorder | Mental disorders

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0017178
UMLS CUI [6]
C0014130
UMLS CUI [7]
C0024115
UMLS CUI [8]
C0027765
UMLS CUI [9]
C0234387
UMLS CUI [10]
C0004936
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT02119650

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-squamous non-small cell lung cancer TNM clinical staging | Recurrent Non-Squamous Non-Small Cell Lung Carcinoma | Status post Intervention | Therapeutic radiology procedure | Operative Surgical Procedures | Chemoradiotherapy | Chemotherapy, Adjuvant | Chemotherapy Neoadjuvant | Adjuvant Chemotherapy Absent | Chemotherapy Neoadjuvant Absent
Item
histologically or cytologically confirmed diagnosis of nonsquamous nsclc that is stage iiib stage iv, or recurrent after prior definitive intervention (radiation, surgery, or chemoradiation therapy, with or without adjuvant or neoadjuvant chemotherapy).
boolean
C4324656 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C4288304 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C0436307 (UMLS CUI [6])
C0085533 (UMLS CUI [7])
C0392920 (UMLS CUI [8,1])
C1298676 (UMLS CUI [8,2])
C0085533 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
C0392920 (UMLS CUI [10,1])
C1298676 (UMLS CUI [10,2])
C0332197 (UMLS CUI [10,3])
Measurable Disease Radiography | Evaluable Disease Radiography
Item
radiographically measurable or evaluable disease.
boolean
C1513041 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C1516986 (UMLS CUI [2,1])
C0034571 (UMLS CUI [2,2])
Life Expectancy
Item
life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Neoplasms Without Mutation | Availability of Therapeutic procedure | EGFR Driver Mutation Negative | ALK gene mutation Negative
Item
tumor without activating driver mutations for which there is available therapy (eg, tumor without mutations in epidermal growth factor receptor or anaplastic lymphoma).
boolean
C0027651 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0026882 (UMLS CUI [1,3])
C0470187 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C4329758 (UMLS CUI [3])
C2825843 (UMLS CUI [4,1])
C1513916 (UMLS CUI [4,2])
Score
Item
an mgps of 1 or 2 as defined below:
boolean
C0449820 (UMLS CUI [1])
Criteria
Item
*criteria:
boolean
C0243161 (UMLS CUI [1])
C-reactive protein measurement | Albumin measurement | Score
Item
c-reactive protein >10 mg/l and albumin ≥35 g/l; score = 1
boolean
C0201657 (UMLS CUI [1])
C0201838 (UMLS CUI [2])
C0449820 (UMLS CUI [3])
C-reactive protein measurement | Albumin measurement | Score
Item
c-reactive protein >10 mg l and albumin <35 g/l; score = 2
boolean
C0201657 (UMLS CUI [1])
C0201838 (UMLS CUI [2])
C0449820 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 to 1.
boolean
C1520224 (UMLS CUI [1])
Renal function | Liver function | Bone Marrow function
Item
adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit.
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Squamous non-small cell lung cancer | Non-Small Cell Lung Carcinoma Adenosquamous
Item
squamous or mixed histology (eg, adenosquamous) nsclc
boolean
C4509816 (UMLS CUI [1])
C0007131 (UMLS CUI [2,1])
C0279557 (UMLS CUI [2,2])
Systemic therapy Advanced disease | Systemic therapy Neoplasm Metastasis
Item
previous systemic therapy for advanced or metastatic disease.
boolean
C1515119 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
CNS metastases
Item
known active central nervous system (cns) metastases.
boolean
C0686377 (UMLS CUI [1])
Cancer Other | Exception Basal cell carcinoma Cured | Exception Squamous cell carcinoma of skin Cured | Exception Superficial carcinoma of urinary bladder | Exception Prostatic Intraepithelial Neoplasias | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm indolent
Item
current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1880198 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1336527 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0282612 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0851140 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0006826 (UMLS CUI [7,2])
C0234227 (UMLS CUI [7,3])
Heart Disease Uncontrolled | Angina Pectoris | Myocardial Infarction | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Treatment required for
Item
current uncontrolled cardiac disease such as angina or myocardial infarction, congestive heart failure including new york heart association functional classification of 3, or arrhythmia requiring treatment.
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0018802 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0003811 (UMLS CUI [5,1])
C0332121 (UMLS CUI [5,2])
Comorbidity Uncontrolled | Kidney Diseases | Liver diseases | Hematological Disease | Gastrointestinal Diseases | Endocrine System Diseases | Lung diseases | Nervous system disorder | Cerebral disorder | Mental disorders
Item
uncontrolled concomitant medical conditions, including, but not limited to, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric diseases.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0024115 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0234387 (UMLS CUI [9])
C0004936 (UMLS CUI [10])
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