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])
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])