Histologically or cytologically confirmed advanced solid neoplasms, recurrent, unresponsive to treatment or with contraindication to standard therapy
Item
(part 1 only) have a histologically or cytologically confirmed diagnosis of advanced solid tumor that has relapsed or is refractory to standard curative or palliative therapy or has a contraindication to standard therapy.
boolean
C0280100 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C0280100 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0280100 (UMLS CUI [3,1])
C1301624 (UMLS CUI [3,2])
C1442989 (UMLS CUI [3,3])
C0087111 (UMLS CUI [3,4])
C0280100 (UMLS CUI [4,1])
C1300072 (UMLS CUI [4,2])
C0280100 (UMLS CUI [5,1])
C0449575 (UMLS CUI [5,2])
C0280100 (UMLS CUI [6,1])
C1265900 (UMLS CUI [6,2])
Histologically or cytologically confirmed NSCLC stage iiiv or iv after prior chemotherapy or targeted therapy
Item
(part 2 only) have histologically or cytologically confirmed diagnosis of stage iiib or iv nsclc and have received 1 or 2 lines of prior chemotherapy or targeted therapy for stage iiib or iv nsclc (second- or third-line).
boolean
C0007131 (UMLS CUI [1,1])
C0449575 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C1265900 (UMLS CUI [2,2])
C0007131 (UMLS CUI [3,1])
C1300072 (UMLS CUI [3,2])
C0007131 (UMLS CUI [4,1])
C1514457 (UMLS CUI [4,2])
C0007131 (UMLS CUI [5,1])
C1514463 (UMLS CUI [5,2])
C2985566 (UMLS CUI [5,3])
Measurable Disease (recist)
Item
have measurable disease per response evaluation criteria in solid tumors (recist) version 1.1.
boolean
C1709926 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Ecog performance
Item
eastern cooperative oncology group (ecog) performance status of 0 to 1
boolean
C1520224 (UMLS CUI [1])
Adequate bone marrow reserve, liver and renal function
Item
have adequate bone marrow reserve, liver function, and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Recent platinum therapy
Item
have received prior platinum therapy in the past 3 months
boolean
C3536920 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Recent therapy with or refractory to cisplatin and gemcitabine
Item
have received prior cisplatin and gemcitabine concomitantly within the last 6 months or are refractory to cisplatin and gemcitabine.
boolean
C0338265 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0338265 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Unresolved toxicity from radio-, chemo- or other targeted therapy like investigational therapy
Item
unresolved toxicity from prior radiation, chemotherapy, or other targeted treatment, including investigational treatment
boolean
C0600688 (UMLS CUI [1,1])
C0443342 (UMLS CUI [1,2])
C0279134 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C0443342 (UMLS CUI [2,2])
C1514457 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C0443342 (UMLS CUI [3,2])
C1514463 (UMLS CUI [3,3])
C2985566 (UMLS CUI [3,4])
C0600688 (UMLS CUI [4,1])
C0443342 (UMLS CUI [4,2])
C1514463 (UMLS CUI [4,3])
C0949266 (UMLS CUI [4,4])
Pregnant, breast feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])