ID

36677

Beskrivning

Phase III Open Label First Line Therapy Study of MEDI 4736 With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC).; ODM derived from: https://clinicaltrials.gov/show/NCT02453282

Länk

https://clinicaltrials.gov/show/NCT02453282

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-Small-Cell Lung Carcinoma (NSCLC) NCT02453282

Engelsk

Eligibility Non-Small-Cell Lung Carcinoma (NSCLC) NCT02453282

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
for inclusion in the study, patients should fulfill the following criteria:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
aged at least 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
documented evidence of stage iv nsclc
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
no activating egfr mutation or alk rearrangement
Beskrivning

Activating EGFR Gene Mutation Negative | ALK Gene Rearrangement Negative

Datatyp

boolean

Alias
UMLS CUI [1]
C4525184
UMLS CUI [2]
C4525178
no prior chemotherapy or any other systemic therapy for recurrent/metastatic nsclc
Beskrivning

Prior Chemotherapy Absent Non-small cell lung cancer recurrent | Systemic therapy Absent Non-small cell lung cancer recurrent | Prior Chemotherapy Absent Non-small cell lung cancer metastatic | Systemic therapy Absent Non-small cell lung cancer metastatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0278517
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0278517
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0278987
UMLS CUI [4,1]
C1515119
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0278987
world health organization (who) performance status of 0 or 1
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients should not enter the study if any of the following exclusion criteria are fulfilled:
Beskrivning

Exclusion Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1550543
mixed small-cell lung cancer and nsclc histology or not otherwise specified (nsclc nos)
Beskrivning

Small cell carcinoma of lung NSCLC Mixed | NSCLC Not Otherwise Specified

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0149925
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C0205430
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C1518425
brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
Beskrivning

Metastatic malignant neoplasm to brain | Compression of spinal cord | Exception Metastatic malignant neoplasm to brain Asymptomatic | Exception Compression of spinal cord Asymptomatic | Exception Metastatic malignant neoplasm to brain Treated Stable | Exception Compression of spinal cord Treated Stable | Exception Steroids Redundant

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0037926
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0220650
UMLS CUI [3,3]
C0231221
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0037926
UMLS CUI [4,3]
C0231221
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0220650
UMLS CUI [5,3]
C1522326
UMLS CUI [5,4]
C0205360
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0037926
UMLS CUI [6,3]
C1522326
UMLS CUI [6,4]
C0205360
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0038317
UMLS CUI [7,3]
C1313915
prior exposure to immunomodulatory therapy (imt), including, but not limited to, other anti-cytotoxic t-lymphocyte-associated antigen 4 (ctla-4), anti-programmed cell death1 (pd-1), anti-programmed cell death ligand 1 (pd-l1), or anti pd-l2 antibodies, excluding therapeutic anticancer vaccines
Beskrivning

Immunomodulation | Anti-CTLA-4 Monoclonal Antibody | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | PD-L2 Monoclonal Antibody | Exception Vaccine Cancer treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C1963758
UMLS CUI [2]
C4289973
UMLS CUI [3]
C4289970
UMLS CUI [4]
C4289971
UMLS CUI [5,1]
C1705357
UMLS CUI [5,2]
C0003250
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0042210
UMLS CUI [6,3]
C0920425
active or prior documented inflammatory bowel disease (eg, crohn's disease, ulcerative colitis)
Beskrivning

Inflammatory Bowel Disease | Crohn Disease | Ulcerative Colitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0010346
UMLS CUI [3]
C0009324
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Similar models

Eligibility Non-Small-Cell Lung Carcinoma (NSCLC) NCT02453282

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
for inclusion in the study, patients should fulfill the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age
Item
aged at least 18 years
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
documented evidence of stage iv nsclc
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Activating EGFR Gene Mutation Negative | ALK Gene Rearrangement Negative
Item
no activating egfr mutation or alk rearrangement
boolean
C4525184 (UMLS CUI [1])
C4525178 (UMLS CUI [2])
Prior Chemotherapy Absent Non-small cell lung cancer recurrent | Systemic therapy Absent Non-small cell lung cancer recurrent | Prior Chemotherapy Absent Non-small cell lung cancer metastatic | Systemic therapy Absent Non-small cell lung cancer metastatic
Item
no prior chemotherapy or any other systemic therapy for recurrent/metastatic nsclc
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0278517 (UMLS CUI [1,3])
C1515119 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0278517 (UMLS CUI [2,3])
C1514457 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0278987 (UMLS CUI [3,3])
C1515119 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0278987 (UMLS CUI [4,3])
WHO performance status scale
Item
world health organization (who) performance status of 0 or 1
boolean
C1298650 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Fulfill
Item
patients should not enter the study if any of the following exclusion criteria are fulfilled:
boolean
C0680251 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Small cell carcinoma of lung NSCLC Mixed | NSCLC Not Otherwise Specified
Item
mixed small-cell lung cancer and nsclc histology or not otherwise specified (nsclc nos)
boolean
C0149925 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0205430 (UMLS CUI [1,3])
C0007131 (UMLS CUI [2,1])
C1518425 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain | Compression of spinal cord | Exception Metastatic malignant neoplasm to brain Asymptomatic | Exception Compression of spinal cord Asymptomatic | Exception Metastatic malignant neoplasm to brain Treated Stable | Exception Compression of spinal cord Treated Stable | Exception Steroids Redundant
Item
brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
boolean
C0220650 (UMLS CUI [1])
C0037926 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0220650 (UMLS CUI [3,2])
C0231221 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0037926 (UMLS CUI [4,2])
C0231221 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0220650 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C0205360 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0037926 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
C0205360 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C0038317 (UMLS CUI [7,2])
C1313915 (UMLS CUI [7,3])
Immunomodulation | Anti-CTLA-4 Monoclonal Antibody | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | PD-L2 Monoclonal Antibody | Exception Vaccine Cancer treatment
Item
prior exposure to immunomodulatory therapy (imt), including, but not limited to, other anti-cytotoxic t-lymphocyte-associated antigen 4 (ctla-4), anti-programmed cell death1 (pd-1), anti-programmed cell death ligand 1 (pd-l1), or anti pd-l2 antibodies, excluding therapeutic anticancer vaccines
boolean
C1963758 (UMLS CUI [1])
C4289973 (UMLS CUI [2])
C4289970 (UMLS CUI [3])
C4289971 (UMLS CUI [4])
C1705357 (UMLS CUI [5,1])
C0003250 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0042210 (UMLS CUI [6,2])
C0920425 (UMLS CUI [6,3])
Inflammatory Bowel Disease | Crohn Disease | Ulcerative Colitis
Item
active or prior documented inflammatory bowel disease (eg, crohn's disease, ulcerative colitis)
boolean
C0021390 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
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