ID

36679

Beskrivning

A Randomized Phase 3 Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) Compared to Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "OAK"; ODM derived from: https://clinicaltrials.gov/show/NCT02008227

Länk

https://clinicaltrials.gov/show/NCT02008227

Nyckelord

Versioner (1)
  1. 2019-05-31 2019-05-31 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

31 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02008227

Engelsk

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02008227

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Adult | Age

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Tumor tissue sample Formalin-fixed paraffin-embedded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C2711483
disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic nsclc or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen or combined modality (e.g., chemoradiation) regimen with curative intent
Beskrivning

Disease Progression | Prior Chemotherapy Platinum-Based | NSCLC Advanced Locally | NSCLC unresectable | Prior Chemotherapy Platinum-Based NSCLC metastatic | Disease recurrence | Adjuvant Chemotherapy Platinum-Based | Chemotherapy Neo-adjuvant Platinum-Based | Combined Modality Therapy Curative intent | Chemoradiotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1514162
UMLS CUI [3,1]
C0007131
UMLS CUI [3,2]
C0205179
UMLS CUI [3,3]
C1517927
UMLS CUI [4,1]
C0007131
UMLS CUI [4,2]
C1519810
UMLS CUI [5,1]
C1514457
UMLS CUI [5,2]
C1514162
UMLS CUI [5,3]
C0278987
UMLS CUI [6]
C0679254
UMLS CUI [7,1]
C0085533
UMLS CUI [7,2]
C1514162
UMLS CUI [8,1]
C0392920
UMLS CUI [8,2]
C1298676
UMLS CUI [8,3]
C1514162
UMLS CUI [9,1]
C0009429
UMLS CUI [9,2]
C1276305
UMLS CUI [10]
C0436307
measurable disease, as defined by recist v1.1
Beskrivning

Measurable Disease

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known active or untreated central nervous system (cns) metastases
Beskrivning

CNS metastases | CNS metastases Untreated

Datatyp

boolean

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

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

Datatyp

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
history of autoimmune disease
Beskrivning

Autoimmune Disease

Datatyp

boolean

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

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

Datatyp

boolean

Alias
UMLS CUI [1]
C1800706
UMLS CUI [2]
C3714636
UMLS CUI [3]
C1960026
UMLS CUI [4]
C0264383
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
active hepatitis b or hepatitis c
Beskrivning

Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
prior treatment with docetaxel
Beskrivning

docetaxel

Datatyp

boolean

Alias
UMLS CUI [1]
C0246415
prior treatment with cd137 agonists, anti-ctla4, anti-pd-1, or anti-pd-l1 therapeutic antibody or pathway-targeting agents
Beskrivning

CD137 Agonists | Anti-CTLA-4 Monoclonal Antibody | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | Targeted Therapy Signal Pathways

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0214721
UMLS CUI [1,2]
C2987634
UMLS CUI [2]
C4289973
UMLS CUI [3]
C4289970
UMLS CUI [4]
C4289971
UMLS CUI [5,1]
C2985566
UMLS CUI [5,2]
C0037080
Tillbaka till toppen

Similar models

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02008227

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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 tissue sample Formalin-fixed paraffin-embedded
Item
representative formalin-fixed paraffin-embedded (ffpe) tumor specimens
boolean
C0475358 (UMLS CUI [1,1])
C2711483 (UMLS CUI [1,2])
Disease Progression | Prior Chemotherapy Platinum-Based | NSCLC Advanced Locally | NSCLC unresectable | Prior Chemotherapy Platinum-Based NSCLC metastatic | Disease recurrence | Adjuvant Chemotherapy Platinum-Based | Chemotherapy Neo-adjuvant Platinum-Based | Combined Modality Therapy Curative intent | Chemoradiotherapy
Item
disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic nsclc or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen or combined modality (e.g., chemoradiation) regimen with curative intent
boolean
C0242656 (UMLS CUI [1])
C1514457 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C0007131 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C1517927 (UMLS CUI [3,3])
C0007131 (UMLS CUI [4,1])
C1519810 (UMLS CUI [4,2])
C1514457 (UMLS CUI [5,1])
C1514162 (UMLS CUI [5,2])
C0278987 (UMLS CUI [5,3])
C0679254 (UMLS CUI [6])
C0085533 (UMLS CUI [7,1])
C1514162 (UMLS CUI [7,2])
C0392920 (UMLS CUI [8,1])
C1298676 (UMLS CUI [8,2])
C1514162 (UMLS CUI [8,3])
C0009429 (UMLS CUI [9,1])
C1276305 (UMLS CUI [9,2])
C0436307 (UMLS CUI [10])
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)
CNS metastases | CNS metastases Untreated
Item
known active or untreated central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
C0686377 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
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 and 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])
Autoimmune Disease
Item
history of autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Idiopathic Pulmonary Fibrosis | Pneumonitis | Drug-induced pneumonitis | Organized pneumonia | Pneumonitis Chest CT | Radiation Pneumonitis Radiation Field allowed
Item
history of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest ct scan. history of radiation pneumonitis in the radiation field (fibrosis) is permitted.
boolean
C1800706 (UMLS CUI [1])
C3714636 (UMLS CUI [2])
C1960026 (UMLS CUI [3])
C0264383 (UMLS CUI [4])
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])
Hepatitis B | Hepatitis C
Item
active hepatitis b or hepatitis c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
docetaxel
Item
prior treatment with docetaxel
boolean
C0246415 (UMLS CUI [1])
CD137 Agonists | Anti-CTLA-4 Monoclonal Antibody | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | Targeted Therapy Signal Pathways
Item
prior treatment with cd137 agonists, anti-ctla4, anti-pd-1, or anti-pd-l1 therapeutic antibody or pathway-targeting agents
boolean
C0214721 (UMLS CUI [1,1])
C2987634 (UMLS CUI [1,2])
C4289973 (UMLS CUI [2])
C4289970 (UMLS CUI [3])
C4289971 (UMLS CUI [4])
C2985566 (UMLS CUI [5,1])
C0037080 (UMLS CUI [5,2])
Tillbaka till toppen 

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