ID

36604

Descrição

A Phase 2 Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) in Patients With PD-L1 Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer - "BIRCH"; ODM derived from: https://clinicaltrials.gov/show/NCT02031458

Link

https://clinicaltrials.gov/show/NCT02031458

Palavras-chave

Versões (1)
  1. 26/05/2019 26/05/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

26 de maio de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT02031458

Inglês

Eligibility Non-Small Cell Lung Cancer NCT02031458

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 years of age
Descrição

Adult | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
locally advanced or metastatic (stage iiib, stage iv, or recurrent) non-small cell lung cancer (nsclc)
Descrição

Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging | Non-small cell lung cancer recurrent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0278987
UMLS CUI [2,2]
C3258246
UMLS CUI [3]
C0278517
representative formalin-fixed paraffin-embedded (ffpe) tumor specimens
Descrição

Tumor Formalin-fixed paraffin-embedded tissue specimen

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C2711483
pd-l1-positive tumor status as determined by an ihc assay based on pd-l1 expression on tumor infiltrating immune cells and/or tumor cells performed by a central laboratory
Descrição

Tumor status PD-L1 Positive Immunohistochemistry | PD-L1 Expression Immune Cell Tumor infiltration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0475752
UMLS CUI [1,2]
C4284303
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C4284303
UMLS CUI [2,2]
C4330475
UMLS CUI [2,3]
C4060690
measurable disease, as defined by recist v1.1
Descrição

Measurable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
eastern cooperative oncology group (ecog) performance status of 0 or 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exception are allowed:
Descrição

Cancer treatment | Chemotherapy | Hormone Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0279025
hormone-replacement therapy or oral contraceptives tkis approved for treatment of nslc discontinued > 7 days prior to cycle 1, day 1
Descrição

Exception Hormone replacement therapy | Exception Oral Contraceptives | Exception Tyrosine kinase inhibitor Treating Non-Small Cell Lung Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0282402
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0009905
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1268567
UMLS CUI [3,3]
C1522326
UMLS CUI [3,4]
C0007131
central nervous system (cns) disease, including treated brain metastases.
Descrição

CNS disorder | Metastatic malignant neoplasm to brain Treated

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C1522326
malignancies other than nsclc within 5 years prior to randomization, with the exception of those with negligible risk of metastases or death and treated with expected curative outcome
Descrição

Malignant Neoplasms | Exception Non-Small Cell Lung Carcinoma | Exception Low Risk Neoplasm Metastasis | Exception Low Risk Death | Exception Curative treatment Malignant Neoplasms

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007131
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3538919
UMLS CUI [3,3]
C0027627
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3538919
UMLS CUI [4,3]
C0011065
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C0006826
history of autoimmune disease
Descrição

Autoimmune Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004364
history of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening ct scan. history of radiation pneumonitis in the radiation field (fibrosis) id permitted.
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1800706
UMLS CUI [2]
C0032285
UMLS CUI [3]
C1960026
UMLS CUI [4]
C0264383
UMLS CUI [5,1]
C3714636
UMLS CUI [5,2]
C0040405
UMLS CUI [6,1]
C0206063
UMLS CUI [6,2]
C1882536
UMLS CUI [6,3]
C0683607
active hepatitis b or hepatitis c
Descrição

Hepatitis B | Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
hiv positive
Descrição

HIV Seropositivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
prior treatment with cd137 agonists, anti-ctla4, anti-pd-1, or anti-pd-l1 therapeutic antibody or pathway-targeting agents
Descrição

Prior Therapy | CD137 agonists | Anti-CTLA-4 Monoclonal Antibody | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | Pathway Targeting Agent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0214721
UMLS CUI [2,2]
C0243192
UMLS CUI [3]
C4289973
UMLS CUI [4]
C4289970
UMLS CUI [5]
C4289971
UMLS CUI [6,1]
C0037080
UMLS CUI [6,2]
C1521840
UMLS CUI [6,3]
C1254351
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT02031458

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging | Non-small cell lung cancer recurrent
Item
locally advanced or metastatic (stage iiib, stage iv, or recurrent) non-small cell lung cancer (nsclc)
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0278517 (UMLS CUI [3])
Tumor Formalin-fixed paraffin-embedded tissue specimen
Item
representative formalin-fixed paraffin-embedded (ffpe) tumor specimens
boolean
C0027651 (UMLS CUI [1,1])
C2711483 (UMLS CUI [1,2])
Tumor status PD-L1 Positive Immunohistochemistry | PD-L1 Expression Immune Cell Tumor infiltration
Item
pd-l1-positive tumor status as determined by an ihc assay based on pd-l1 expression on tumor infiltrating immune cells and/or tumor cells performed by a central laboratory
boolean
C0475752 (UMLS CUI [1,1])
C4284303 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C4284303 (UMLS CUI [2,1])
C4330475 (UMLS CUI [2,2])
C4060690 (UMLS CUI [2,3])
Measurable Disease
Item
measurable disease, as defined by recist v1.1
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer treatment | Chemotherapy | Hormone Therapy
Item
any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exception are allowed:
boolean
C0920425 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
Exception Hormone replacement therapy | Exception Oral Contraceptives | Exception Tyrosine kinase inhibitor Treating Non-Small Cell Lung Carcinoma
Item
hormone-replacement therapy or oral contraceptives tkis approved for treatment of nslc discontinued > 7 days prior to cycle 1, day 1
boolean
C1705847 (UMLS CUI [1,1])
C0282402 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0009905 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1268567 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C0007131 (UMLS CUI [3,4])
CNS disorder | Metastatic malignant neoplasm to brain Treated
Item
central nervous system (cns) disease, including treated brain metastases.
boolean
C0007682 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Malignant Neoplasms | Exception Non-Small Cell Lung Carcinoma | Exception Low Risk Neoplasm Metastasis | Exception Low Risk Death | Exception Curative treatment Malignant Neoplasms
Item
malignancies other than nsclc within 5 years prior to randomization, with the exception of those with negligible risk of metastases or death and treated with expected curative outcome
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C3538919 (UMLS CUI [3,2])
C0027627 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C3538919 (UMLS CUI [4,2])
C0011065 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0006826 (UMLS CUI [5,3])
Autoimmune Disease
Item
history of autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Idiopathic Pulmonary Fibrosis | Pneumonia | Drug-induced pneumonitis | Organized pneumonia | Pneumonitis CT scan | Radiation Pneumonitis Radiation Field allowed
Item
history of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening ct scan. history of radiation pneumonitis in the radiation field (fibrosis) id permitted.
boolean
C1800706 (UMLS CUI [1])
C0032285 (UMLS CUI [2])
C1960026 (UMLS CUI [3])
C0264383 (UMLS CUI [4])
C3714636 (UMLS CUI [5,1])
C0040405 (UMLS CUI [5,2])
C0206063 (UMLS CUI [6,1])
C1882536 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
Hepatitis B | Hepatitis C
Item
active hepatitis b or hepatitis c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
HIV Seropositivity
Item
hiv positive
boolean
C0019699 (UMLS CUI [1])
Prior Therapy | CD137 agonists | Anti-CTLA-4 Monoclonal Antibody | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | Pathway Targeting Agent
Item
prior treatment with cd137 agonists, anti-ctla4, anti-pd-1, or anti-pd-l1 therapeutic antibody or pathway-targeting agents
boolean
C1514463 (UMLS CUI [1])
C0214721 (UMLS CUI [2,1])
C0243192 (UMLS CUI [2,2])
C4289973 (UMLS CUI [3])
C4289970 (UMLS CUI [4])
C4289971 (UMLS CUI [5])
C0037080 (UMLS CUI [6,1])
C1521840 (UMLS CUI [6,2])
C1254351 (UMLS CUI [6,3])
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