ID

35136

Description

Sym004 in Subjects With Stage IV Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02083679

Link

https://clinicaltrials.gov/show/NCT02083679

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 NCT02083679

English

Eligibility Carcinoma, Non-Small-Cell Lung NCT02083679

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female outpatients (except where inpatient stay is required for medical need at the investigator's discretion) at least 18 years of age at the time of informed consent
Description

Outpatients | Exception Patient need for Inpatient stay | Age

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0686904
UMLS CUI [2,3]
C0420512
UMLS CUI [3]
C0001779
histologically-confirmed nsclc stage iv disease (according to the seventh edition of the lung cancer staging system)
Description

Non-Small Cell Lung Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
eligibility for platinum-based chemotherapy
Description

Eligibility Chemotherapy Platinum-Based

Data type

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1514162
tumor tissue available for egfr expression analysis
Description

Availability of Tumor tissue sample | EGFR Protein Expression Analysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [2,1]
C0034802
UMLS CUI [2,2]
C1882495
measurable disease defined as 1 or more target lesions according to response evaluation criteria in solid tumors version 1.1 (recist 1.1)
Description

Measurable Disease | Target Lesion Quantity

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1265611
life expectancy of at least 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
eastern cooperative oncology group (ecog) performance status less than or equal to 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
other protocol defined inclusion criteria could apply
Description

Inclusion criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous therapy for stage iv nsclc, or neo- or adjuvant chemotherapy or chemoradiotherapy within the previous 6 months
Description

Prior Therapy Non-Small Cell Lung Carcinoma TNM clinical staging | Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant | Chemoradiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1298676
UMLS CUI [3]
C0085533
UMLS CUI [4]
C0436307
previous investigational drug or any anticancer therapy in the 30 days (or 5 half-lives for non-cytotoxics, whichever is shorter) prior to the start of trial treatment
Description

Investigational New Drugs | Cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0920425
in countries where anaplastic lymphoma kinase (alk) inhibitors are available for the treatment of nsclc, subjects need to have been screened for alk fusion gene rearrangements and excluded if positive, unless previously treated and progressed on an appropriate tyrosine kinase inhibitor (tki) therapy
Description

ALK gene rearrangement positive Screening

Data type

boolean

Alias
UMLS CUI [1,1]
C3888914
UMLS CUI [1,2]
C1710032
in countries where egfr tkis are available for the treatment of nsclc, subjects need to have been screened for egfr mutations and excluded if positive, unless previously treated and progressed on an appropriate tki therapy
Description

EGFR gene mutation Screening Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C3266992
UMLS CUI [1,2]
C1710032
UMLS CUI [1,3]
C1514241
concurrent chronic immunosuppressive or hormone anticancer therapy (except other physiologic hormone replacement)
Description

Therapeutic immunosuppression chronic | Hormone Therapy chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0205191
known brain metastases (unless asymptomatic and treated) or leptomeningeal metastases, including suspected leptomeningeal spread with positive cytology
Description

Metastatic malignant neoplasm to brain | Exception Metastatic malignant neoplasm to brain Treated Asymptomatic | Metastatic Malignant Neoplasm to the Leptomeninges | Metastatic Malignant Neoplasm to the Leptomeninges Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0220650
UMLS CUI [2,3]
C1522326
UMLS CUI [2,4]
C0231221
UMLS CUI [3]
C1704231
UMLS CUI [4,1]
C1704231
UMLS CUI [4,2]
C0750491
history of any other malignancy within 5 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix)
Description

Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
other protocol defined exclusion criteria could apply
Description

Exclusion Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT02083679

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Exception Patient need for Inpatient stay | Age
Item
male or female outpatients (except where inpatient stay is required for medical need at the investigator's discretion) at least 18 years of age at the time of informed consent
boolean
C0029921 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0420512 (UMLS CUI [2,3])
C0001779 (UMLS CUI [3])
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histologically-confirmed nsclc stage iv disease (according to the seventh edition of the lung cancer staging system)
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Eligibility Chemotherapy Platinum-Based
Item
eligibility for platinum-based chemotherapy
boolean
C1548635 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1514162 (UMLS CUI [1,3])
Availability of Tumor tissue sample | EGFR Protein Expression Analysis
Item
tumor tissue available for egfr expression analysis
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0034802 (UMLS CUI [2,1])
C1882495 (UMLS CUI [2,2])
Measurable Disease | Target Lesion Quantity
Item
measurable disease defined as 1 or more target lesions according to response evaluation criteria in solid tumors version 1.1 (recist 1.1)
boolean
C1513041 (UMLS CUI [1])
C2986546 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Life Expectancy
Item
life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status less than or equal to 1
boolean
C1520224 (UMLS CUI [1])
Inclusion criteria Study Protocol
Item
other protocol defined inclusion criteria could apply
boolean
C1512693 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Non-Small Cell Lung Carcinoma TNM clinical staging | Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant | Chemoradiotherapy
Item
previous therapy for stage iv nsclc, or neo- or adjuvant chemotherapy or chemoradiotherapy within the previous 6 months
boolean
C1514463 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C1298676 (UMLS CUI [2,2])
C0085533 (UMLS CUI [3])
C0436307 (UMLS CUI [4])
Investigational New Drugs | Cancer treatment
Item
previous investigational drug or any anticancer therapy in the 30 days (or 5 half-lives for non-cytotoxics, whichever is shorter) prior to the start of trial treatment
boolean
C0013230 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
ALK gene rearrangement positive Screening
Item
in countries where anaplastic lymphoma kinase (alk) inhibitors are available for the treatment of nsclc, subjects need to have been screened for alk fusion gene rearrangements and excluded if positive, unless previously treated and progressed on an appropriate tyrosine kinase inhibitor (tki) therapy
boolean
C3888914 (UMLS CUI [1,1])
C1710032 (UMLS CUI [1,2])
EGFR gene mutation Screening Positive
Item
in countries where egfr tkis are available for the treatment of nsclc, subjects need to have been screened for egfr mutations and excluded if positive, unless previously treated and progressed on an appropriate tki therapy
boolean
C3266992 (UMLS CUI [1,1])
C1710032 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Therapeutic immunosuppression chronic | Hormone Therapy chronic
Item
concurrent chronic immunosuppressive or hormone anticancer therapy (except other physiologic hormone replacement)
boolean
C0021079 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain | Exception Metastatic malignant neoplasm to brain Treated Asymptomatic | Metastatic Malignant Neoplasm to the Leptomeninges | Metastatic Malignant Neoplasm to the Leptomeninges Suspected
Item
known brain metastases (unless asymptomatic and treated) or leptomeningeal metastases, including suspected leptomeningeal spread with positive cytology
boolean
C0220650 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0231221 (UMLS CUI [2,4])
C1704231 (UMLS CUI [3])
C1704231 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
history of any other malignancy within 5 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Exclusion Criteria Study Protocol
Item
other protocol defined exclusion criteria could apply
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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