ID

35150

Description

Pembrolizumab Alone and In Combination With ACP-196 in Subjects With Advanced Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02448303

Link

https://clinicaltrials.gov/show/NCT02448303

Keywords

Versions (1)
  1. 2/19/19 2/19/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 19, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT02448303

English

Eligibility Carcinoma, Non-Small-Cell Lung NCT02448303

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women ≥ 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
histologically confirmed recurrent or metastatic nsclc (adenocarcinoma, large cell, squamous cell, or not otherwise specified) that has either progressed during or after platinum-based chemotherapy
Description

Non-small cell lung cancer recurrent | Non-small cell lung cancer metastatic | Adenocarcinoma of lung | Large cell carcinoma of lung | Squamous cell carcinoma of lung | Chemotherapy Platinum-Based | Disease Progression

Data type

boolean

Alias
UMLS CUI [1]
C0278517
UMLS CUI [2]
C0278987
UMLS CUI [3]
C0152013
UMLS CUI [4]
C0345958
UMLS CUI [5]
C0149782
UMLS CUI [6,1]
C0392920
UMLS CUI [6,2]
C1514162
UMLS CUI [7]
C0242656
received at least 1 platinum-based chemotherapy regimen. note: subjects with egfr mutations or alk translocations are required to have received prior therapy with appropriate tki; prior platinum-based chemotherapy is not required for this specific patient population
Description

Chemotherapy Platinum-Based Quantity | EGFR gene mutation Requirement Tyrosine Kinase Inhibitors | ALK Gene Translocation Requirement Tyrosine Kinase Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1514162
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C3266992
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C2757011
UMLS CUI [3,1]
C4329227
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C2757011
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior malignancy (other than lung cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years
Description

Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Disease Free Duration

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
known central nervous system metastases and/or carcinomatous meningitis
Description

CNS metastases | Meningeal Carcinomatosis

Data type

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0220654
significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
Description

Cardiovascular Disease | Cardiac Arrhythmia Uncontrolled | ARRHYTHMIA SYMPTOMATIC | Congestive heart failure | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0741212
UMLS CUI [4]
C0018802
UMLS CUI [5]
C0027051
malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass
Description

Malabsorption Syndrome | Disease Affecting Gastrointestinal function | Stomach Excision | Small intestine excision | Inflammatory Bowel Disease Symptomatic | Partial bowel obstruction | Intestinal Obstruction Complete | Restriction Gastric | Bariatric Surgery | Gastric Bypass

Data type

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0516983
UMLS CUI [3]
C1304699
UMLS CUI [4]
C0192601
UMLS CUI [5,1]
C0021390
UMLS CUI [5,2]
C0231220
UMLS CUI [6]
C1328480
UMLS CUI [7,1]
C0021843
UMLS CUI [7,2]
C0205197
UMLS CUI [8,1]
C0443288
UMLS CUI [8,2]
C1704242
UMLS CUI [9]
C1456587
UMLS CUI [10]
C0017125
breastfeeding or pregnant
Description

Breast Feeding | Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT02448303

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Non-small cell lung cancer recurrent | Non-small cell lung cancer metastatic | Adenocarcinoma of lung | Large cell carcinoma of lung | Squamous cell carcinoma of lung | Chemotherapy Platinum-Based | Disease Progression
Item
histologically confirmed recurrent or metastatic nsclc (adenocarcinoma, large cell, squamous cell, or not otherwise specified) that has either progressed during or after platinum-based chemotherapy
boolean
C0278517 (UMLS CUI [1])
C0278987 (UMLS CUI [2])
C0152013 (UMLS CUI [3])
C0345958 (UMLS CUI [4])
C0149782 (UMLS CUI [5])
C0392920 (UMLS CUI [6,1])
C1514162 (UMLS CUI [6,2])
C0242656 (UMLS CUI [7])
Chemotherapy Platinum-Based Quantity | EGFR gene mutation Requirement Tyrosine Kinase Inhibitors | ALK Gene Translocation Requirement Tyrosine Kinase Inhibitors
Item
received at least 1 platinum-based chemotherapy regimen. note: subjects with egfr mutations or alk translocations are required to have received prior therapy with appropriate tki; prior platinum-based chemotherapy is not required for this specific patient population
boolean
C0392920 (UMLS CUI [1,1])
C1514162 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3266992 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C2757011 (UMLS CUI [2,3])
C4329227 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C2757011 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Disease Free Duration
Item
prior malignancy (other than lung cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
CNS metastases | Meningeal Carcinomatosis
Item
known central nervous system metastases and/or carcinomatous meningitis
boolean
C0686377 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
Cardiovascular Disease | Cardiac Arrhythmia Uncontrolled | ARRHYTHMIA SYMPTOMATIC | Congestive heart failure | Myocardial Infarction
Item
significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
boolean
C0007222 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0741212 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
Malabsorption Syndrome | Disease Affecting Gastrointestinal function | Stomach Excision | Small intestine excision | Inflammatory Bowel Disease Symptomatic | Partial bowel obstruction | Intestinal Obstruction Complete | Restriction Gastric | Bariatric Surgery | Gastric Bypass
Item
malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass
boolean
C0024523 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0516983 (UMLS CUI [2,3])
C1304699 (UMLS CUI [3])
C0192601 (UMLS CUI [4])
C0021390 (UMLS CUI [5,1])
C0231220 (UMLS CUI [5,2])
C1328480 (UMLS CUI [6])
C0021843 (UMLS CUI [7,1])
C0205197 (UMLS CUI [7,2])
C0443288 (UMLS CUI [8,1])
C1704242 (UMLS CUI [8,2])
C1456587 (UMLS CUI [9])
C0017125 (UMLS CUI [10])
Breast Feeding | Pregnancy
Item
breastfeeding or pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
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