0 Ratings
ID

41191

Description

Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung); ODM derived from: https://clinicaltrials.gov/show/NCT02134015

Link

https://clinicaltrials.gov/show/NCT02134015

Keywords

Versions (1)
  1. 7/10/20 7/10/20 -
Copyright Holder

See clinicaltrials.gov

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July 10, 2020

DOI

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License

Creative Commons BY 4.0
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    Eligibility Lung Cancer NCT02134015

    English

    Eligibility Lung Cancer NCT02134015

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. must be greater or equal to 20 years of age
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. must have cytologically or histologically confirmed nsclc with either:
    Description

    Non-Small Cell Lung Carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0007131
    metastatic disease (stage iv) or
    Description

    Neoplasm Metastasis TNM clinical staging

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027627
    UMLS CUI [1,2]
    C3258246
    stage iiib disease not amenable to surgery or curative intent.
    Description

    Disease TNM clinical staging | Disease Inappropriate Operative Surgical Procedure | Disease Inappropriate Curative - procedure intent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C3258246
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C1548788
    UMLS CUI [2,3]
    C0543467
    UMLS CUI [3,1]
    C0012634
    UMLS CUI [3,2]
    C1548788
    UMLS CUI [3,3]
    C1276305
    note: it is permissible to use either ajcc version 6.0 or the ajcc version 7.0 staging system. for sites that use ajcc version 7.0, t4m0 patients with other ipsilateral nodules and n0-n2 are still eligible.
    Description

    TNM clinical staging

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3258246
    3. if tumor histology is adenocarcinoma, must have wild-type egfr genotype as assessed by a validated assay that includes exon 19 deletion and exon 21 (l858r) substitution.
    Description

    Adenocarcinoma | EGFR gene Wild Type | EGFR exon 19 deletion | EGFR Exon 21 Mutation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001418
    UMLS CUI [2,1]
    C1414313
    UMLS CUI [2,2]
    C1883559
    UMLS CUI [3]
    C3889117
    UMLS CUI [4]
    C4289654
    4. must have received one or two prior lines of systemic chemotherapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy.
    Description

    Systemic Chemotherapy Quantity Advanced disease | Systemic Chemotherapy Quantity Neoplasm Metastasis | Platinum Doublet

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1883256
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [1,3]
    C0679246
    UMLS CUI [2,1]
    C1883256
    UMLS CUI [2,2]
    C1265611
    UMLS CUI [2,3]
    C0027627
    UMLS CUI [3]
    C5206469
    5. must have disease progression or recurrence documented by radiographic assessment following treatment after last chemotherapy or chemoradiation regimen (completed within the previous 12 months).
    Description

    Disease Progression | Disease recurrence | Status post Chemotherapy | Status post Chemoradiotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0242656
    UMLS CUI [2]
    C0679254
    UMLS CUI [3,1]
    C0231290
    UMLS CUI [3,2]
    C0392920
    UMLS CUI [4,1]
    C0231290
    UMLS CUI [4,2]
    C0436307
    6. must have available recent (before treatment start) or archival tumor specimen.
    Description

    Availability of Tumor tissue sample

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0470187
    UMLS CUI [1,2]
    C0475358
    7. must have measurable disease for part a, measurable disease or non-measurable disease for part b
    Description

    Measurable Disease | Non-Measurable Lesion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    UMLS CUI [2]
    C1334988
    8. must have eastern cooperative oncology group (ecog) performance status of 0 or 1
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    9. must have adequate hematological function
    Description

    Hematologic function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0221130
    10. must have adequate renal function
    Description

    Renal function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    11. must have adequate hepatic function
    Description

    Liver function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    12. agreement to use effective contraception while on treatment and for at least 6 months after end of treatment
    Description

    Agreement Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0680240
    UMLS CUI [1,2]
    C0700589
    13. must have provided informed consent for study participation.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. lung adenocarcinoma with an anaplastic lymphoma kinase (alk) gene rearrangement
    Description

    Adenocarcinoma of lung | ALK Gene Rearrangement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0152013
    UMLS CUI [2]
    C4068350
    2. left ventricular ejection fraction (lvef) less than 45%
    Description

    Left ventricular ejection fraction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    3. prior egfr-targeted regimen, anti-her2, anti-her3, or anti-her4 therapy
    Description

    EGFR targeted therapy | Targeted Therapy HER2 | Targeted Therapy HER3 | Targeted Therapy HER4

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4733187
    UMLS CUI [2,1]
    C2985566
    UMLS CUI [2,2]
    C0069515
    UMLS CUI [3,1]
    C2985566
    UMLS CUI [3,2]
    C0812265
    UMLS CUI [4,1]
    C2985566
    UMLS CUI [4,2]
    C0812267
    4. history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for greater or equal to 5 years
    Description

    Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Curative treatment Disease In situ | Exception Curative treatment Solid Neoplasm | Exception Disease Free Duration

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0699893
    UMLS CUI [2,3]
    C1522326
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C1273390
    UMLS CUI [3,3]
    C0012634
    UMLS CUI [3,4]
    C0444498
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C1273390
    UMLS CUI [4,3]
    C0280100
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0012634
    UMLS CUI [5,3]
    C0332296
    UMLS CUI [5,4]
    C0449238
    5. history of corneal disease
    Description

    Corneal Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0010034
    6. history of interstitial lung disease (ild)
    Description

    Lung Disease, Interstitial

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0206062
    7. clinically active brain metastases
    Description

    Metastatic malignant neoplasm to brain

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0220650
    8. uncontrolled hypertension
    Description

    Uncontrolled hypertension

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1868885
    9. clinically significant ecg changes
    Description

    ECG changes Clinical Significance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0855329
    UMLS CUI [1,2]
    C2826293
    10. clinically significant (in the opinion of the investigator) ascites or pleural effusion requiring chronic medical intervention
    Description

    Ascites | Pleural effusion | Requirement Intervention chronic

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0003962
    UMLS CUI [2]
    C0032227
    UMLS CUI [3,1]
    C1514873
    UMLS CUI [3,2]
    C0184661
    UMLS CUI [3,3]
    C0205191
    11. myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or unstable cardiac arrhythmia requiring medication
    Description

    Myocardial Infarction | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia Unstable | Requirement Pharmaceutical Preparations

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    UMLS CUI [2]
    C0742758
    UMLS CUI [3]
    C0002965
    UMLS CUI [4,1]
    C0003811
    UMLS CUI [4,2]
    C0443343
    UMLS CUI [5,1]
    C1514873
    UMLS CUI [5,2]
    C0013227
    12. treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 4 weeks before study drug treatment
    Description

    Cancer treatment | Antibody Therapy | Retinoid therapy of cancer | Hormone Therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0920425
    UMLS CUI [2]
    C0281176
    UMLS CUI [3]
    C0598926
    UMLS CUI [4]
    C0279025
    13. therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment; or palliative radiation within 2 weeks before study drug treatment
    Description

    Therapeutic radiology procedure | Major surgery | Palliative course of radiotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    UMLS CUI [2]
    C0679637
    UMLS CUI [3]
    C0475092
    14. participation in clinical drug trials within 4 weeks
    Description

    Study Subject Participation Status | Clinical Trial | Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0008976
    UMLS CUI [3]
    C0013230
    15. uncontrolled infection requiring iv antibiotics, antivirals, or antifungals, known human immunodeficiency virus (hiv) infection, or active hepatitis b or c infection.
    Description

    Communicable Disease Uncontrolled | Requirement Antibiotics Intravenous | Requirement Antiviral Agents | Requirement Antifungal Agents | HIV Infection | Hepatitis B | Hepatitis C

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2,1]
    C1514873
    UMLS CUI [2,2]
    C0003232
    UMLS CUI [2,3]
    C1522726
    UMLS CUI [3,1]
    C1514873
    UMLS CUI [3,2]
    C0003451
    UMLS CUI [4,1]
    C1514873
    UMLS CUI [4,2]
    C0003308
    UMLS CUI [5]
    C0019693
    UMLS CUI [6]
    C0019163
    UMLS CUI [7]
    C0019196
    16. history of hypersensitivity to any of the study drugs or to any excipients.
    Description

    Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0013230
    UMLS CUI [2,3]
    C0015237
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    Similar models

    Eligibility Lung Cancer NCT02134015

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    1. must be greater or equal to 20 years of age
    boolean
    C0001779 (UMLS CUI [1])
    Non-Small Cell Lung Carcinoma
    Item
    2. must have cytologically or histologically confirmed nsclc with either:
    boolean
    C0007131 (UMLS CUI [1])
    Neoplasm Metastasis TNM clinical staging
    Item
    metastatic disease (stage iv) or
    boolean
    C0027627 (UMLS CUI [1,1])
    C3258246 (UMLS CUI [1,2])
    Disease TNM clinical staging | Disease Inappropriate Operative Surgical Procedure | Disease Inappropriate Curative - procedure intent
    Item
    stage iiib disease not amenable to surgery or curative intent.
    boolean
    C0012634 (UMLS CUI [1,1])
    C3258246 (UMLS CUI [1,2])
    C0012634 (UMLS CUI [2,1])
    C1548788 (UMLS CUI [2,2])
    C0543467 (UMLS CUI [2,3])
    C0012634 (UMLS CUI [3,1])
    C1548788 (UMLS CUI [3,2])
    C1276305 (UMLS CUI [3,3])
    TNM clinical staging
    Item
    note: it is permissible to use either ajcc version 6.0 or the ajcc version 7.0 staging system. for sites that use ajcc version 7.0, t4m0 patients with other ipsilateral nodules and n0-n2 are still eligible.
    boolean
    C3258246 (UMLS CUI [1])
    Adenocarcinoma | EGFR gene Wild Type | EGFR exon 19 deletion | EGFR Exon 21 Mutation
    Item
    3. if tumor histology is adenocarcinoma, must have wild-type egfr genotype as assessed by a validated assay that includes exon 19 deletion and exon 21 (l858r) substitution.
    boolean
    C0001418 (UMLS CUI [1])
    C1414313 (UMLS CUI [2,1])
    C1883559 (UMLS CUI [2,2])
    C3889117 (UMLS CUI [3])
    C4289654 (UMLS CUI [4])
    Systemic Chemotherapy Quantity Advanced disease | Systemic Chemotherapy Quantity Neoplasm Metastasis | Platinum Doublet
    Item
    4. must have received one or two prior lines of systemic chemotherapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy.
    boolean
    C1883256 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0679246 (UMLS CUI [1,3])
    C1883256 (UMLS CUI [2,1])
    C1265611 (UMLS CUI [2,2])
    C0027627 (UMLS CUI [2,3])
    C5206469 (UMLS CUI [3])
    Disease Progression | Disease recurrence | Status post Chemotherapy | Status post Chemoradiotherapy
    Item
    5. must have disease progression or recurrence documented by radiographic assessment following treatment after last chemotherapy or chemoradiation regimen (completed within the previous 12 months).
    boolean
    C0242656 (UMLS CUI [1])
    C0679254 (UMLS CUI [2])
    C0231290 (UMLS CUI [3,1])
    C0392920 (UMLS CUI [3,2])
    C0231290 (UMLS CUI [4,1])
    C0436307 (UMLS CUI [4,2])
    Availability of Tumor tissue sample
    Item
    6. must have available recent (before treatment start) or archival tumor specimen.
    boolean
    C0470187 (UMLS CUI [1,1])
    C0475358 (UMLS CUI [1,2])
    Measurable Disease | Non-Measurable Lesion
    Item
    7. must have measurable disease for part a, measurable disease or non-measurable disease for part b
    boolean
    C1513041 (UMLS CUI [1])
    C1334988 (UMLS CUI [2])
    ECOG performance status
    Item
    8. must have eastern cooperative oncology group (ecog) performance status of 0 or 1
    boolean
    C1520224 (UMLS CUI [1])
    Hematologic function
    Item
    9. must have adequate hematological function
    boolean
    C0221130 (UMLS CUI [1])
    Renal function
    Item
    10. must have adequate renal function
    boolean
    C0232804 (UMLS CUI [1])
    Liver function
    Item
    11. must have adequate hepatic function
    boolean
    C0232741 (UMLS CUI [1])
    Agreement Contraceptive methods
    Item
    12. agreement to use effective contraception while on treatment and for at least 6 months after end of treatment
    boolean
    C0680240 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    Informed Consent
    Item
    13. must have provided informed consent for study participation.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Adenocarcinoma of lung | ALK Gene Rearrangement
    Item
    1. lung adenocarcinoma with an anaplastic lymphoma kinase (alk) gene rearrangement
    boolean
    C0152013 (UMLS CUI [1])
    C4068350 (UMLS CUI [2])
    Left ventricular ejection fraction
    Item
    2. left ventricular ejection fraction (lvef) less than 45%
    boolean
    C0428772 (UMLS CUI [1])
    EGFR targeted therapy | Targeted Therapy HER2 | Targeted Therapy HER3 | Targeted Therapy HER4
    Item
    3. prior egfr-targeted regimen, anti-her2, anti-her3, or anti-her4 therapy
    boolean
    C4733187 (UMLS CUI [1])
    C2985566 (UMLS CUI [2,1])
    C0069515 (UMLS CUI [2,2])
    C2985566 (UMLS CUI [3,1])
    C0812265 (UMLS CUI [3,2])
    C2985566 (UMLS CUI [4,1])
    C0812267 (UMLS CUI [4,2])
    Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Curative treatment Disease In situ | Exception Curative treatment Solid Neoplasm | Exception Disease Free Duration
    Item
    4. history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for greater or equal to 5 years
    boolean
    C0006826 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0699893 (UMLS CUI [2,2])
    C1522326 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C1273390 (UMLS CUI [3,2])
    C0012634 (UMLS CUI [3,3])
    C0444498 (UMLS CUI [3,4])
    C1705847 (UMLS CUI [4,1])
    C1273390 (UMLS CUI [4,2])
    C0280100 (UMLS CUI [4,3])
    C1705847 (UMLS CUI [5,1])
    C0012634 (UMLS CUI [5,2])
    C0332296 (UMLS CUI [5,3])
    C0449238 (UMLS CUI [5,4])
    Corneal Disease
    Item
    5. history of corneal disease
    boolean
    C0010034 (UMLS CUI [1])
    Lung Disease, Interstitial
    Item
    6. history of interstitial lung disease (ild)
    boolean
    C0206062 (UMLS CUI [1])
    Metastatic malignant neoplasm to brain
    Item
    7. clinically active brain metastases
    boolean
    C0220650 (UMLS CUI [1])
    Uncontrolled hypertension
    Item
    8. uncontrolled hypertension
    boolean
    C1868885 (UMLS CUI [1])
    ECG changes Clinical Significance
    Item
    9. clinically significant ecg changes
    boolean
    C0855329 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    Ascites | Pleural effusion | Requirement Intervention chronic
    Item
    10. clinically significant (in the opinion of the investigator) ascites or pleural effusion requiring chronic medical intervention
    boolean
    C0003962 (UMLS CUI [1])
    C0032227 (UMLS CUI [2])
    C1514873 (UMLS CUI [3,1])
    C0184661 (UMLS CUI [3,2])
    C0205191 (UMLS CUI [3,3])
    Myocardial Infarction | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia Unstable | Requirement Pharmaceutical Preparations
    Item
    11. myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or unstable cardiac arrhythmia requiring medication
    boolean
    C0027051 (UMLS CUI [1])
    C0742758 (UMLS CUI [2])
    C0002965 (UMLS CUI [3])
    C0003811 (UMLS CUI [4,1])
    C0443343 (UMLS CUI [4,2])
    C1514873 (UMLS CUI [5,1])
    C0013227 (UMLS CUI [5,2])
    Cancer treatment | Antibody Therapy | Retinoid therapy of cancer | Hormone Therapy
    Item
    12. treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 4 weeks before study drug treatment
    boolean
    C0920425 (UMLS CUI [1])
    C0281176 (UMLS CUI [2])
    C0598926 (UMLS CUI [3])
    C0279025 (UMLS CUI [4])
    Therapeutic radiology procedure | Major surgery | Palliative course of radiotherapy
    Item
    13. therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment; or palliative radiation within 2 weeks before study drug treatment
    boolean
    C1522449 (UMLS CUI [1])
    C0679637 (UMLS CUI [2])
    C0475092 (UMLS CUI [3])
    Study Subject Participation Status | Clinical Trial | Investigational New Drugs
    Item
    14. participation in clinical drug trials within 4 weeks
    boolean
    C2348568 (UMLS CUI [1])
    C0008976 (UMLS CUI [2])
    C0013230 (UMLS CUI [3])
    Communicable Disease Uncontrolled | Requirement Antibiotics Intravenous | Requirement Antiviral Agents | Requirement Antifungal Agents | HIV Infection | Hepatitis B | Hepatitis C
    Item
    15. uncontrolled infection requiring iv antibiotics, antivirals, or antifungals, known human immunodeficiency virus (hiv) infection, or active hepatitis b or c infection.
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C1514873 (UMLS CUI [2,1])
    C0003232 (UMLS CUI [2,2])
    C1522726 (UMLS CUI [2,3])
    C1514873 (UMLS CUI [3,1])
    C0003451 (UMLS CUI [3,2])
    C1514873 (UMLS CUI [4,1])
    C0003308 (UMLS CUI [4,2])
    C0019693 (UMLS CUI [5])
    C0019163 (UMLS CUI [6])
    C0019196 (UMLS CUI [7])
    Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient
    Item
    16. history of hypersensitivity to any of the study drugs or to any excipients.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0013230 (UMLS CUI [2,2])
    C0015237 (UMLS CUI [2,3])
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