ID

36602

Description

Study of Pembrolizumab (MK-3475) in Participants With Advanced Non-small Cell Lung Cancer (MK-3475-025/KEYNOTE-025); ODM derived from: https://clinicaltrials.gov/show/NCT02007070

Link

https://clinicaltrials.gov/show/NCT02007070

Keywords

Versions (1)
  1. 5/26/19 5/26/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 26, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT02007070

English

Eligibility Non-small Cell Lung Cancer NCT02007070

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed diagnosis of non-small cell lung cancer (nsclc) that is pd-l1 positive per central laboratory review
Description

Non-Small Cell Lung Carcinoma PD-L1 Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C4284303
at least one measurable lesion.
Description

Measurable lesion Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
radiographic progression of nsclc after treatment with a platinum-containing doublet for stage iiib/iv or recurrent disease
Description

Non-Small Cell Lung Carcinoma Progression Radiography | Therapy Double Platinum-Based | Disease TNM clinical staging | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0242656
UMLS CUI [1,3]
C0034571
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205173
UMLS CUI [2,3]
C1514162
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C3258246
UMLS CUI [4]
C0277556
eastern cooperative oncology group (ecog) performance scale 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks of the first dose of trial treatment
Description

Cytotoxic Chemotherapy Systemic | Biological treatment | Major surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C1531518
UMLS CUI [3]
C0679637
systemic steroid therapy within 3 days prior to the first dose of trial treatment or any other form of immunosuppressive medication
Description

Steroid therapy Systemic | Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0021081
expected to require any other form of systemic or localized antineoplastic therapy while on trial
Description

Cancer treatment Systemic Required | Cancer treatment Localized Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C1514873
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0392752
UMLS CUI [2,3]
C1514873
history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer
Description

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Superficial carcinoma of urinary bladder | Exception Squamous cell carcinoma of skin | Exception Carcinoma in Situ

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1336527
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007099
active central nervous system (cns) metastases and/or carcinomatous meningitis
Description

CNS metastases | Meningeal Carcinomatosis

Data type

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0220654
active autoimmune disease or documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
Description

Autoimmune Disease Requirement Systemic steroids | Autoimmune Disease Requirement Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C2825233
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021081
prior therapy with an anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-cytotoxic t-lymphocyte-associated antigen-4 (ctla-4) antibody
Description

Prior Therapy | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | PD-L2 Monoclonal Antibody | CD137 Monoclonal Antibody | Anti-CTLA-4 Monoclonal Antibody

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C4289970
UMLS CUI [3]
C4289971
UMLS CUI [4,1]
C1705357
UMLS CUI [4,2]
C0003250
UMLS CUI [5,1]
C0214721
UMLS CUI [5,2]
C0003250
UMLS CUI [6]
C4289973
concurrent or past history of interstitial lung disease
Description

Lung Disease, Interstitial

Data type

boolean

Alias
UMLS CUI [1]
C0206062
pregnant or breast-feeding, or expecting to conceive or father children within the projected duration of the study, starting with screening visit through 120 days after the last dose of pembrolizumab
Description

Pregnancy | Breast Feeding | Pregnancy Expected | Reproduction Expected

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1517001
UMLS CUI [4,1]
C0035150
UMLS CUI [4,2]
C1517001
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Similar models

Eligibility Non-small Cell Lung Cancer NCT02007070

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma PD-L1 Positive
Item
histologically or cytologically confirmed diagnosis of non-small cell lung cancer (nsclc) that is pd-l1 positive per central laboratory review
boolean
C0007131 (UMLS CUI [1,1])
C4284303 (UMLS CUI [1,2])
Measurable lesion Quantity
Item
at least one measurable lesion.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma Progression Radiography | Therapy Double Platinum-Based | Disease TNM clinical staging | Recurrent disease
Item
radiographic progression of nsclc after treatment with a platinum-containing doublet for stage iiib/iv or recurrent disease
boolean
C0007131 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])
C1514162 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C0277556 (UMLS CUI [4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance scale 0 or 1
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cytotoxic Chemotherapy Systemic | Biological treatment | Major surgery
Item
systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks of the first dose of trial treatment
boolean
C0677881 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2])
C0679637 (UMLS CUI [3])
Steroid therapy Systemic | Immunosuppressive Agents
Item
systemic steroid therapy within 3 days prior to the first dose of trial treatment or any other form of immunosuppressive medication
boolean
C0149783 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2])
Cancer treatment Systemic Required | Cancer treatment Localized Required
Item
expected to require any other form of systemic or localized antineoplastic therapy while on trial
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0920425 (UMLS CUI [2,1])
C0392752 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Superficial carcinoma of urinary bladder | Exception Squamous cell carcinoma of skin | Exception Carcinoma in Situ
Item
history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1336527 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0007099 (UMLS CUI [5,2])
CNS metastases | Meningeal Carcinomatosis
Item
active central nervous system (cns) metastases and/or carcinomatous meningitis
boolean
C0686377 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
Autoimmune Disease Requirement Systemic steroids | Autoimmune Disease Requirement Immunosuppressive Agents
Item
active autoimmune disease or documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
boolean
C0004364 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C2825233 (UMLS CUI [1,3])
C0004364 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021081 (UMLS CUI [2,3])
Prior Therapy | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | PD-L2 Monoclonal Antibody | CD137 Monoclonal Antibody | Anti-CTLA-4 Monoclonal Antibody
Item
prior therapy with an anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-cytotoxic t-lymphocyte-associated antigen-4 (ctla-4) antibody
boolean
C1514463 (UMLS CUI [1])
C4289970 (UMLS CUI [2])
C4289971 (UMLS CUI [3])
C1705357 (UMLS CUI [4,1])
C0003250 (UMLS CUI [4,2])
C0214721 (UMLS CUI [5,1])
C0003250 (UMLS CUI [5,2])
C4289973 (UMLS CUI [6])
Lung Disease, Interstitial
Item
concurrent or past history of interstitial lung disease
boolean
C0206062 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy Expected | Reproduction Expected
Item
pregnant or breast-feeding, or expecting to conceive or father children within the projected duration of the study, starting with screening visit through 120 days after the last dose of pembrolizumab
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
C0035150 (UMLS CUI [4,1])
C1517001 (UMLS CUI [4,2])
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