Age | Non-Small Cell Lung Carcinoma TNM clinical staging | Tumor Progression | Prior Therapy Quantity Advanced disease | Chemotherapy | Epidermal growth factor receptor inhibitor
Item
1. men and women, 18 years or older, with histologically or cytologically-confirmed, stage iiib/iv non-small cell lung cancer with tumor progression following at least one prior treatment regimen (either chemotherapy or an epidermal growth factor receptor inhibitor) for advanced disease. there is no restriction on the number of prior treatment regimens allowed.
boolean
C0001779 (UMLS CUI [1])
C0007131 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0178874 (UMLS CUI [3])
C1514463 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0679246 (UMLS CUI [4,3])
C0392920 (UMLS CUI [5])
C1443775 (UMLS CUI [6])
ECOG performance status
Item
2. eastern cooperative oncology group performance score of 0 to 1.
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
3. adequate organ function.
boolean
C0678852 (UMLS CUI [1])
Contraceptive methods
Item
4. adequate contraception (if appropriate).
boolean
C0700589 (UMLS CUI [1])
Consent Tumor tissue sample
Item
5. consent to retrieve archival tumor tissue.
boolean
C1511481 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
Neoplasm Biopsy Repeated
Item
6. consent to repeated tumor biopsy (dose expansion phase).
boolean
C0027651 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Cancer treatment Systemic | Investigational New Drugs | Exception Erlotinib
Item
1. prior systemic cancer-directed treatments or investigational drugs within 4 weeks or 5 half lives, whichever is shorter except erlotinib which may be continued with intervention in subjects allocated in arm a.
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1135135 (UMLS CUI [3,2])
CNS metastases Symptomatic
Item
2. symptomatic central nervous system metastases.
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Pancreatitis | Pancreatitis, Chronic
Item
3. acute or chronic pancreatitis.
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Diarrhea persistent | Malabsorption CTCAE Grades
Item
4. persistent diarrhea or malabsorption > grade 2, despite medical management.
boolean
C0743188 (UMLS CUI [1])
C3714745 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Impaired cardiac function | Heart Disease
Item
5. impaired cardiac function or significant cardiac disease.
boolean
C0232166 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
Treatment Diabetes Mellitus | Fasting blood glucose measurement | Hemoglobin A1c measurement
Item
6. diabetes on active treatment, fasting blood glucose > 126 mg/dl, hba1c > 6.5%.
boolean
C0087111 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0428568 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic
Item
7. known human immunodeficiency virus, chronic hepatitis b or c infection.
boolean
C0019693 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
TORC1 TORC2 Inhibitor | PI3K Inhibitor | AKT Inhibitor
Item
8. prior treatment with an investigational dual torc1/torc2, pi3k, or akt inhibitor. prior treatment with rapalogs is allowed.
boolean
C3152111 (UMLS CUI [1,1])
C3152112 (UMLS CUI [1,2])
C1999216 (UMLS CUI [1,3])
C1519050 (UMLS CUI [2])
C0812228 (UMLS CUI [3,1])
C1999216 (UMLS CUI [3,2])
Major surgery | Patient recovered Effects of Therapy
Item
9. major surgery < 2 weeks prior to starting study drugs. no specific wash out is required for radiotherapy. subjects must have recovered from any effects of recent therapy that might confound the safety evaluation of study drug.
boolean
C0679637 (UMLS CUI [1])
C1115804 (UMLS CUI [2,1])
C1704420 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Contraceptive methods Inadequate
Item
10. pregnant or breastfeeding, inadequate contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
Second Cancers Requirement Systemic therapy
Item
11. history of concurrent second malignancies requiring ongoing systemic treatment.
boolean
C0751623 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])