Age
Item
age >/= 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status (ps) 0 - 1
boolean
C1520224 (UMLS CUI [1])
Squamous non-small cell lung cancer
Item
histologically confirmed squamous nsclc patients
boolean
C4509816 (UMLS CUI [1])
Squamous non-small cell lung cancer Advanced Locally TNM clinical staging | Squamous non-small cell lung cancer metastatic TNM clinical staging
Item
locally advanced or metastatic (stage iiib or iv) squamous nsclc
boolean
C4509816 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C4509816 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
Systemic Chemotherapy Absent Non-small cell lung cancer metastatic | Targeted Therapy Absent Non-small cell lung cancer metastatic
Item
no prior systemic chemotherapy, targeted therapy for metastatic nsclc
boolean
C1883256 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0278987 (UMLS CUI [1,3])
C2985566 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0278987 (UMLS CUI [2,3])
Measurable lesion Quantity Radiology
Item
evidence of at least one radiologically measurable lesion as per response evaluation criteria in solid tumors (recist) version 1.1
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0043299 (UMLS CUI [1,3])
Hematologic function | Liver function | Renal function
Item
adequate hematological, liver and renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Use of Contraceptive methods
Item
use of highly effective contraception
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Investigational New Drugs
Item
concurrent therapy with any other investigational drug
boolean
C0013230 (UMLS CUI [1])
Central Nervous System Neoplasms, Primary | CNS metastases
Item
history or clinical evidence of central nervous system (cns) primary tumors or metastases
boolean
C0751620 (UMLS CUI [1])
C0686377 (UMLS CUI [2])
Comorbidity Uncontrolled Affecting Protocol Compliance | Comorbidity Uncontrolled Affecting Research results | Diabetic - poor control | Cardiovascular Disease | Communicable Disease Uncontrolled
Item
evidence of significant, uncontrolled concomitant diseases, which could affect compliance with the protocol or interpretation of results, including uncontrolled diabetes mellitus and/or significant cardiovascular disease or uncontrolled infection
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C0421258 (UMLS CUI [3])
C0007222 (UMLS CUI [4])
C0009450 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
Medical contraindication Investigational New Drugs | Etiology Comorbidity | Etiology Dysfunction Metabolic | Etiology Physical Examination | Etiology Laboratory test finding
Item
any other diseases, metabolic dysfunction, a physical examination finding or a clinical laboratory finding, giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0009488 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C3887504 (UMLS CUI [3,2])
C0311400 (UMLS CUI [3,3])
C0015127 (UMLS CUI [4,1])
C0031809 (UMLS CUI [4,2])
C0015127 (UMLS CUI [5,1])
C0587081 (UMLS CUI [5,2])
Major surgery | Traumatic injury | Patient need for Major surgery
Item
major surgery or significant traumatic injury < 28 days prior to the first study treatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
boolean
C0679637 (UMLS CUI [1])
C3263723 (UMLS CUI [2])
C0686904 (UMLS CUI [3,1])
C0679637 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer Other Affecting Protocol Compliance | Cancer Other Affecting Interpretation Research results | Exception Malignant Neoplasms Previous | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
history of other malignancies that could affect compliance with protocol or interpretation of results. patients with malignancies diagnosed more than five years prior to study day one, adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer are generally eligible
boolean
C1707251 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C1707251 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0205156 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0007117 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0553723 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])