ID

36682

Beschreibung

A Comparative Study of MPDL3280A (Anti-PDL1 Antibody) With Cisplatin or Carboplatin + Pemetrexed in Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower 110]; ODM derived from: https://clinicaltrials.gov/show/NCT02409342

Link

https://clinicaltrials.gov/show/NCT02409342

Stichworte

Versionen (3)
  1. 31.05.19 31.05.19 -
  2. 01.06.19 01.06.19 -
  3. 27.09.21 27.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

1. Juni 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02409342

Englisch

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02409342

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients 18 years of age or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically or cytologically confirmed, stage iv non-squamous nsclc without any prior treatment
Beschreibung

Non-Squamous Non-Small Cell Lung Carcinoma TNM clinical staging | Prior Therapy Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4528750
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0332197
tumor pd-l1 expression as determined by immunohistochemistry (ihc) assay of archival tumor tissue or tissue obtained at screening
Beschreibung

Tumor tissue sample PD-L1 Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C4284303
eastern cooperative oncology group (ecog) performance status 0 to 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
measurable disease as defined by response evaluation criteria in solid tumors (recist v1.1)
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
adequate hematologic and end-organ function
Beschreibung

Hematologic function | Organ function

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0678852
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
active or untreated central nervous system (cns) metastases as determined by computed tomorgaphy (ct) or magnetic resonance imaging (mri) evaluation
Beschreibung

CNS metastases CT | CNS metastases Untreated CT | CNS metastases MRI | CNS metastases Untreated MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0332155
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C0686377
UMLS CUI [3,2]
C0024485
UMLS CUI [4,1]
C0686377
UMLS CUI [4,2]
C0332155
UMLS CUI [4,3]
C0024485
malignancies other than nsclc within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
Beschreibung

Cancer Other | Exception Low Risk Metastasis | Exception Low Risk Death | Exception Curative procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3538919
UMLS CUI [2,3]
C0027627
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3538919
UMLS CUI [3,3]
C0011065
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1276305
pregnant or lactating women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of autoimmune disease
Beschreibung

Autoimmune Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (ct) scan. history of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Beschreibung

Idiopathic Pulmonary Fibrosis | Organized pneumonia | Drug-induced pneumonitis | Pneumonitis Idiopathic | Pneumonitis Chest CT | Radiation Pneumonitis Radiation Field allowed

Datentyp

boolean

Alias
UMLS CUI [1]
C1800706
UMLS CUI [2]
C0264383
UMLS CUI [3]
C1960026
UMLS CUI [4,1]
C3714636
UMLS CUI [4,2]
C0332240
UMLS CUI [5,1]
C3714636
UMLS CUI [5,2]
C0202823
UMLS CUI [6,1]
C0206063
UMLS CUI [6,2]
C1882536
UMLS CUI [6,3]
C0683607
positive test for human immunodeficiency virus (hiv)
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
active hepatitis b or hepatitis c
Beschreibung

Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
prior treatment with cd137 agonists or immune checkpoint blockade therapies, anti pd1, and anti-pd-l1 therapeutic antibody
Beschreibung

CD137 Agonists | Immune system Blockade Therapy | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0214721
UMLS CUI [1,2]
C2987634
UMLS CUI [2,1]
C0020962
UMLS CUI [2,2]
C0332206
UMLS CUI [2,3]
C0087111
UMLS CUI [3]
C4289970
UMLS CUI [4]
C4289971
severe infection within 4 weeks prior to randomization
Beschreibung

Communicable Disease Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
significant history of cardiovascular disease
Beschreibung

Cardiovascular Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
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Ähnliche Modelle

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02409342

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Non-Squamous Non-Small Cell Lung Carcinoma TNM clinical staging | Prior Therapy Absent
Item
histologically or cytologically confirmed, stage iv non-squamous nsclc without any prior treatment
boolean
C4528750 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Tumor tissue sample PD-L1 Positive
Item
tumor pd-l1 expression as determined by immunohistochemistry (ihc) assay of archival tumor tissue or tissue obtained at screening
boolean
C0475358 (UMLS CUI [1,1])
C4284303 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 to 1
boolean
C1520224 (UMLS CUI [1])
Measurable Disease
Item
measurable disease as defined by response evaluation criteria in solid tumors (recist v1.1)
boolean
C1513041 (UMLS CUI [1])
Hematologic function | Organ function
Item
adequate hematologic and end-organ function
boolean
C0221130 (UMLS CUI [1])
C0678852 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
CNS metastases CT | CNS metastases Untreated CT | CNS metastases MRI | CNS metastases Untreated MRI
Item
active or untreated central nervous system (cns) metastases as determined by computed tomorgaphy (ct) or magnetic resonance imaging (mri) evaluation
boolean
C0686377 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C0686377 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
C0686377 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
Cancer Other | Exception Low Risk Metastasis | Exception Low Risk Death | Exception Curative procedure
Item
malignancies other than nsclc within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3538919 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C3538919 (UMLS CUI [3,2])
C0011065 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1276305 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Autoimmune Disease
Item
history of autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Idiopathic Pulmonary Fibrosis | Organized pneumonia | Drug-induced pneumonitis | Pneumonitis Idiopathic | Pneumonitis Chest CT | Radiation Pneumonitis Radiation Field allowed
Item
history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (ct) scan. history of radiation pneumonitis in the radiation field (fibrosis) is permitted.
boolean
C1800706 (UMLS CUI [1])
C0264383 (UMLS CUI [2])
C1960026 (UMLS CUI [3])
C3714636 (UMLS CUI [4,1])
C0332240 (UMLS CUI [4,2])
C3714636 (UMLS CUI [5,1])
C0202823 (UMLS CUI [5,2])
C0206063 (UMLS CUI [6,1])
C1882536 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
HIV Seropositivity
Item
positive test for human immunodeficiency virus (hiv)
boolean
C0019699 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
active hepatitis b or hepatitis c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
CD137 Agonists | Immune system Blockade Therapy | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody
Item
prior treatment with cd137 agonists or immune checkpoint blockade therapies, anti pd1, and anti-pd-l1 therapeutic antibody
boolean
C0214721 (UMLS CUI [1,1])
C2987634 (UMLS CUI [1,2])
C0020962 (UMLS CUI [2,1])
C0332206 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C4289970 (UMLS CUI [3])
C4289971 (UMLS CUI [4])
Communicable Disease Severe
Item
severe infection within 4 weeks prior to randomization
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Cardiovascular Disease
Item
significant history of cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
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