Outpatients | Exception Patient need for Inpatient stay | Age
Item
male or female outpatients (except where inpatient stay is required for medical need at the investigator's discretion) at least 18 years of age at the time of informed consent
boolean
C0029921 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0420512 (UMLS CUI [2,3])
C0001779 (UMLS CUI [3])
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histologically-confirmed nsclc stage iv disease (according to the seventh edition of the lung cancer staging system)
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Eligibility Chemotherapy Platinum-Based
Item
eligibility for platinum-based chemotherapy
boolean
C1548635 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1514162 (UMLS CUI [1,3])
Availability of Tumor tissue sample | EGFR Protein Expression Analysis
Item
tumor tissue available for egfr expression analysis
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0034802 (UMLS CUI [2,1])
C1882495 (UMLS CUI [2,2])
Measurable Disease | Target Lesion Quantity
Item
measurable disease defined as 1 or more target lesions according to response evaluation criteria in solid tumors version 1.1 (recist 1.1)
boolean
C1513041 (UMLS CUI [1])
C2986546 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Life Expectancy
Item
life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status less than or equal to 1
boolean
C1520224 (UMLS CUI [1])
Inclusion criteria Study Protocol
Item
other protocol defined inclusion criteria could apply
boolean
C1512693 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Prior Therapy Non-Small Cell Lung Carcinoma TNM clinical staging | Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant | Chemoradiotherapy
Item
previous therapy for stage iv nsclc, or neo- or adjuvant chemotherapy or chemoradiotherapy within the previous 6 months
boolean
C1514463 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C1298676 (UMLS CUI [2,2])
C0085533 (UMLS CUI [3])
C0436307 (UMLS CUI [4])
Investigational New Drugs | Cancer treatment
Item
previous investigational drug or any anticancer therapy in the 30 days (or 5 half-lives for non-cytotoxics, whichever is shorter) prior to the start of trial treatment
boolean
C0013230 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
ALK gene rearrangement positive Screening
Item
in countries where anaplastic lymphoma kinase (alk) inhibitors are available for the treatment of nsclc, subjects need to have been screened for alk fusion gene rearrangements and excluded if positive, unless previously treated and progressed on an appropriate tyrosine kinase inhibitor (tki) therapy
boolean
C3888914 (UMLS CUI [1,1])
C1710032 (UMLS CUI [1,2])
EGFR gene mutation Screening Positive
Item
in countries where egfr tkis are available for the treatment of nsclc, subjects need to have been screened for egfr mutations and excluded if positive, unless previously treated and progressed on an appropriate tki therapy
boolean
C3266992 (UMLS CUI [1,1])
C1710032 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Therapeutic immunosuppression chronic | Hormone Therapy chronic
Item
concurrent chronic immunosuppressive or hormone anticancer therapy (except other physiologic hormone replacement)
boolean
C0021079 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain | Exception Metastatic malignant neoplasm to brain Treated Asymptomatic | Metastatic Malignant Neoplasm to the Leptomeninges | Metastatic Malignant Neoplasm to the Leptomeninges Suspected
Item
known brain metastases (unless asymptomatic and treated) or leptomeningeal metastases, including suspected leptomeningeal spread with positive cytology
boolean
C0220650 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0231221 (UMLS CUI [2,4])
C1704231 (UMLS CUI [3])
C1704231 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
history of any other malignancy within 5 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Exclusion Criteria Study Protocol
Item
other protocol defined exclusion criteria could apply
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])