ID

37260

Description

A Study of the Combination of Necitumumab (LY3012211) and Pembrolizumab (MK3475) in Participants With NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT02451930

Link

https://clinicaltrials.gov/show/NCT02451930

Keywords

Versions (1)
  1. 7/12/19 7/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Stage IV Non-Small Cell Lung Cancer NCT02451930

English

Eligibility Stage IV Non-Small Cell Lung Cancer NCT02451930

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the participant has stage iv nsclc.
Description

Non-Small Cell Lung Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
part a: nsclc stage iv (any type)
Description

Non-Small Cell Lung Carcinoma Type Any TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
UMLS CUI [1,4]
C3258246
part b: nsclc stage iv (squamous and nonsquamous)
Description

Non-Small Cell Lung Carcinoma TNM clinical staging | Squamous non-small cell lung cancer TNM clinical staging | Non-squamous non-small cell lung cancer TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C4509816
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C4324656
UMLS CUI [3,2]
C3258246
the participant must have progressed after 1 platinum-based chemotherapy regimen. prior treatment with epidermal growth factor receptor (egfr)-tyrosine kinase inhibitor and anaplastic lymphoma kinase (alk) inhibitors is mandatory in patients whose tumor has an egfr activating mutation or alk translocations. prior vascular endothelial growth factor (vegf)/vegf receptor-targeting agents and neoadjuvant/adjuvant therapies are permitted.
Description

Disease Progression | Status post Chemotherapy Platinum-Based | Epidermal growth factor receptor inhibitor | Anaplastic lymphoma kinase inhibitors | Neoplasm EGFR Activating Mutation | Neoplasm ALK Gene Translocation | Pharmaceutical Preparations Targeting Vascular Endothelial Growth Factors | Pharmaceutical Preparations Targeting VEGF Receptor | Neoadjuvant Therapy | Adjuvant therapy

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C1514162
UMLS CUI [3]
C1443775
UMLS CUI [4,1]
C0252409
UMLS CUI [4,2]
C0243077
UMLS CUI [5,1]
C0027651
UMLS CUI [5,2]
C2984891
UMLS CUI [6,1]
C0027651
UMLS CUI [6,2]
C4329227
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C1521840
UMLS CUI [7,3]
C1256770
UMLS CUI [8,1]
C0013227
UMLS CUI [8,2]
C1521840
UMLS CUI [8,3]
C0148199
UMLS CUI [9]
C0600558
UMLS CUI [10]
C0677850
measurable disease at the time of study entry as defined by response evaluation criteria in solid tumors version 1.1 (recist 1.1).
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
the participant has tumor tissue available for biomarker analyses.
Description

Availability of Tumor tissue sample | Tumor tissue sample Biomarker Analysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C1879847
the participant has adequate organ function.
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
eastern cooperative oncology group performance status (ecog ps) score of 0-1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the participant is currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device.
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
prior treatment with an anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-cytotoxic t lymphocyte-associated antigen-4 antibody (including ipilimumab or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways) or egfr-directed monoclonal antibody (mab) is not permitted.
Description

Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | PD-L2 Monoclonal Antibody | CD137 Monoclonal Antibody | Anti-CTLA-4 Monoclonal Antibody | ipilimumab | Antibody Targeting T cell costimulation | Antibody Targeting T-Cell Activation Pathway | Pharmaceutical Preparations Targeting T cell costimulation | Pharmaceutical Preparations Targeting T-Cell Activation Pathway | Monoclonal Antibody Targeting Epidermal Growth Factor Receptor

Data type

boolean

Alias
UMLS CUI [1]
C4289970
UMLS CUI [2]
C4289971
UMLS CUI [3,1]
C1705357
UMLS CUI [3,2]
C0003250
UMLS CUI [4,1]
C0214721
UMLS CUI [4,2]
C0003250
UMLS CUI [5]
C4289973
UMLS CUI [6]
C1367202
UMLS CUI [7,1]
C0003241
UMLS CUI [7,2]
C1521840
UMLS CUI [7,3]
C1622572
UMLS CUI [8,1]
C0003241
UMLS CUI [8,2]
C1521840
UMLS CUI [8,3]
C1515122
UMLS CUI [9,1]
C0013227
UMLS CUI [9,2]
C1521840
UMLS CUI [9,3]
C1622572
UMLS CUI [10,1]
C0013227
UMLS CUI [10,2]
C1521840
UMLS CUI [10,3]
C1515122
UMLS CUI [11,1]
C0003250
UMLS CUI [11,2]
C1521840
UMLS CUI [11,3]
C0034802
have a serious concomitant systemic disorder or significant cardiac disease.
Description

Systemic disease Serious | Heart Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0018799
the participant has undergone major surgery or received any investigational therapy in the 30-days prior to study enrollment.
Description

Major surgery | Therapy, Investigational

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0949266
the participant has undergone chest irradiation within 4 weeks prior to receiving study treatment.
Description

Radiotherapy to thorax

Data type

boolean

Alias
UMLS CUI [1]
C4038705
the participant has brain metastases that are symptomatic.
Description

Metastatic malignant neoplasm to brain Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
the participant has a history of arterial thromboembolism event (ate) or venous thromboembolism event (vte) within 3 months prior to study enrollment. participants with history of vte beyond 3 months prior to study enrollment can be enrolled if they are appropriately treated with low molecular weight heparin.
Description

Arterial thromboembolism | Venous Thromboembolism

Data type

boolean

Alias
UMLS CUI [1]
C3544094
UMLS CUI [2]
C1861172
the participant has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab or pembrolizumab, or any other contraindication to one of the administered treatments.
Description

Hypersensitivity Investigational Therapy Component | Hypersensitivity Necitumumab Ingredient | Hypersensitivity Pembrolizumab Ingredient | Medical contraindication Investigational Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0949266
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2352806
UMLS CUI [2,3]
C1550600
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C3658706
UMLS CUI [3,3]
C1550600
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0949266
the participant is pregnant or breastfeeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
the participant has a concurrent active malignancy. previous history of malignancy is permitted, provided that the participant has been free of disease for ≥3 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, preinvasive carcinoma of the cervix, or any cancers that in the judgment of the investigator and sponsor may not affect the interpretation of results (for example, prostate, bladder).
Description

Cancer Other | Exception Disease Free Duration | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Prostate carcinoma | Exception Carcinoma of bladder

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
UMLS CUI [2,4]
C0449238
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0600139
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0699885
history of interstitial lung disease, pneumonitis, autoimmune disease or syndrome that requires steroids or immunosuppressive agents.
Description

Lung Disease, Interstitial | Pneumonitis | Autoimmune Diseases | Syndrome Requirement Steroids | Syndrome Requirement Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0206062
UMLS CUI [2]
C3714636
UMLS CUI [3]
C0004364
UMLS CUI [4,1]
C0039082
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0038317
UMLS CUI [5,1]
C0039082
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0021081
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Similar models

Eligibility Stage IV Non-Small Cell Lung Cancer NCT02451930

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
the participant has stage iv nsclc.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma Type Any TNM clinical staging
Item
part a: nsclc stage iv (any type)
boolean
C0007131 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
Non-Small Cell Lung Carcinoma TNM clinical staging | Squamous non-small cell lung cancer TNM clinical staging | Non-squamous non-small cell lung cancer TNM clinical staging
Item
part b: nsclc stage iv (squamous and nonsquamous)
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C4509816 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C4324656 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
Disease Progression | Status post Chemotherapy Platinum-Based | Epidermal growth factor receptor inhibitor | Anaplastic lymphoma kinase inhibitors | Neoplasm EGFR Activating Mutation | Neoplasm ALK Gene Translocation | Pharmaceutical Preparations Targeting Vascular Endothelial Growth Factors | Pharmaceutical Preparations Targeting VEGF Receptor | Neoadjuvant Therapy | Adjuvant therapy
Item
the participant must have progressed after 1 platinum-based chemotherapy regimen. prior treatment with epidermal growth factor receptor (egfr)-tyrosine kinase inhibitor and anaplastic lymphoma kinase (alk) inhibitors is mandatory in patients whose tumor has an egfr activating mutation or alk translocations. prior vascular endothelial growth factor (vegf)/vegf receptor-targeting agents and neoadjuvant/adjuvant therapies are permitted.
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C1514162 (UMLS CUI [2,3])
C1443775 (UMLS CUI [3])
C0252409 (UMLS CUI [4,1])
C0243077 (UMLS CUI [4,2])
C0027651 (UMLS CUI [5,1])
C2984891 (UMLS CUI [5,2])
C0027651 (UMLS CUI [6,1])
C4329227 (UMLS CUI [6,2])
C0013227 (UMLS CUI [7,1])
C1521840 (UMLS CUI [7,2])
C1256770 (UMLS CUI [7,3])
C0013227 (UMLS CUI [8,1])
C1521840 (UMLS CUI [8,2])
C0148199 (UMLS CUI [8,3])
C0600558 (UMLS CUI [9])
C0677850 (UMLS CUI [10])
Measurable Disease
Item
measurable disease at the time of study entry as defined by response evaluation criteria in solid tumors version 1.1 (recist 1.1).
boolean
C1513041 (UMLS CUI [1])
Availability of Tumor tissue sample | Tumor tissue sample Biomarker Analysis
Item
the participant has tumor tissue available for biomarker analyses.
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0475358 (UMLS CUI [2,1])
C1879847 (UMLS CUI [2,2])
Organ function
Item
the participant has adequate organ function.
boolean
C0678852 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group performance status (ecog ps) score of 0-1.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
the participant is currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | PD-L2 Monoclonal Antibody | CD137 Monoclonal Antibody | Anti-CTLA-4 Monoclonal Antibody | ipilimumab | Antibody Targeting T cell costimulation | Antibody Targeting T-Cell Activation Pathway | Pharmaceutical Preparations Targeting T cell costimulation | Pharmaceutical Preparations Targeting T-Cell Activation Pathway | Monoclonal Antibody Targeting Epidermal Growth Factor Receptor
Item
prior treatment with an anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-cytotoxic t lymphocyte-associated antigen-4 antibody (including ipilimumab or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways) or egfr-directed monoclonal antibody (mab) is not permitted.
boolean
C4289970 (UMLS CUI [1])
C4289971 (UMLS CUI [2])
C1705357 (UMLS CUI [3,1])
C0003250 (UMLS CUI [3,2])
C0214721 (UMLS CUI [4,1])
C0003250 (UMLS CUI [4,2])
C4289973 (UMLS CUI [5])
C1367202 (UMLS CUI [6])
C0003241 (UMLS CUI [7,1])
C1521840 (UMLS CUI [7,2])
C1622572 (UMLS CUI [7,3])
C0003241 (UMLS CUI [8,1])
C1521840 (UMLS CUI [8,2])
C1515122 (UMLS CUI [8,3])
C0013227 (UMLS CUI [9,1])
C1521840 (UMLS CUI [9,2])
C1622572 (UMLS CUI [9,3])
C0013227 (UMLS CUI [10,1])
C1521840 (UMLS CUI [10,2])
C1515122 (UMLS CUI [10,3])
C0003250 (UMLS CUI [11,1])
C1521840 (UMLS CUI [11,2])
C0034802 (UMLS CUI [11,3])
Systemic disease Serious | Heart Disease
Item
have a serious concomitant systemic disorder or significant cardiac disease.
boolean
C0442893 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2])
Major surgery | Therapy, Investigational
Item
the participant has undergone major surgery or received any investigational therapy in the 30-days prior to study enrollment.
boolean
C0679637 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Radiotherapy to thorax
Item
the participant has undergone chest irradiation within 4 weeks prior to receiving study treatment.
boolean
C4038705 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Symptomatic
Item
the participant has brain metastases that are symptomatic.
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Arterial thromboembolism | Venous Thromboembolism
Item
the participant has a history of arterial thromboembolism event (ate) or venous thromboembolism event (vte) within 3 months prior to study enrollment. participants with history of vte beyond 3 months prior to study enrollment can be enrolled if they are appropriately treated with low molecular weight heparin.
boolean
C3544094 (UMLS CUI [1])
C1861172 (UMLS CUI [2])
Hypersensitivity Investigational Therapy Component | Hypersensitivity Necitumumab Ingredient | Hypersensitivity Pembrolizumab Ingredient | Medical contraindication Investigational Therapy
Item
the participant has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab or pembrolizumab, or any other contraindication to one of the administered treatments.
boolean
C0020517 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C2352806 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C3658706 (UMLS CUI [3,2])
C1550600 (UMLS CUI [3,3])
C1301624 (UMLS CUI [4,1])
C0949266 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
the participant is pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer Other | Exception Disease Free Duration | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Prostate carcinoma | Exception Carcinoma of bladder
Item
the participant has a concurrent active malignancy. previous history of malignancy is permitted, provided that the participant has been free of disease for ≥3 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, preinvasive carcinoma of the cervix, or any cancers that in the judgment of the investigator and sponsor may not affect the interpretation of results (for example, prostate, bladder).
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0600139 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0699885 (UMLS CUI [7,2])
Lung Disease, Interstitial | Pneumonitis | Autoimmune Diseases | Syndrome Requirement Steroids | Syndrome Requirement Immunosuppressive Agents
Item
history of interstitial lung disease, pneumonitis, autoimmune disease or syndrome that requires steroids or immunosuppressive agents.
boolean
C0206062 (UMLS CUI [1])
C3714636 (UMLS CUI [2])
C0004364 (UMLS CUI [3])
C0039082 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0038317 (UMLS CUI [4,3])
C0039082 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0021081 (UMLS CUI [5,3])
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