ID

35136

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02083679

Nyckelord

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

See clinicaltrials.gov

Uppladdad den

19 februari 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT02083679

Engelsk

Eligibility Carcinoma, Non-Small-Cell Lung NCT02083679

1 Formulär  
Inclusion Criteria
Beskrivning

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
Beskrivning

Outpatients | Exception Patient need for Inpatient stay | Age

Datatyp

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)
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging

Datatyp

boolean

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

Eligibility Chemotherapy Platinum-Based

Datatyp

boolean

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

Availability of Tumor tissue sample | EGFR Protein Expression Analysis

Datatyp

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)
Beskrivning

Measurable Disease | Target Lesion Quantity

Datatyp

boolean

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

Life Expectancy

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

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

Inclusion criteria Study Protocol

Datatyp

boolean

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

Exclusion Criteria

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

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

Datatyp

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
Beskrivning

Investigational New Drugs | Cancer treatment

Datatyp

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
Beskrivning

ALK gene rearrangement positive Screening

Datatyp

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
Beskrivning

EGFR gene mutation Screening Positive

Datatyp

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)
Beskrivning

Therapeutic immunosuppression chronic | Hormone Therapy chronic

Datatyp

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
Beskrivning

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

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Exclusion Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563
Tillbaka till toppen

Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT02083679

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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