Run-in Period Number
Item
run-in phase i
boolean
C3274438 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma TNM clinical staging | Non-small cell lung cancer recurrent Squamous Cell Histology
Item
1. histologically or cytologically confirmed diagnosis of stage iiib/iv or recurrent non small cell lung cancer (nsclc) with squamous cell histology.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0278517 (UMLS CUI [2,1])
C0221910 (UMLS CUI [2,2])
C4048239 (UMLS CUI [2,3])
Measurable Disease
Item
2. measurable disease according to response evaluation criteria in solid tumours ( recist 1.1).
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
3. patient eastern cooperative oncology group (ecog) score of 0-1.
boolean
C1520224 (UMLS CUI [1])
Age
Item
4. male or female patients age = 18 years.
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
5. life expectancy of at least three (3) months.
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
6. written informed consent in accordance with international conference on harmonisation- good clinical practice (ich-gcp) guidelines.
boolean
C0021430 (UMLS CUI [1])
Run-in Period Number
Item
phase ii - in addition to the above criteria:
boolean
C3274438 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Stable Disease | Status post Chemotherapy cycle Quantity Cisplatin
Item
7. radiologically-confirmed at least stable disease after 2 prior cycles of cisplatin /
boolean
C0677946 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1302181 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0008838 (UMLS CUI [2,4])
Gemcitabine Chemotherapy
Item
gemcitabine chemotherapy.
boolean
C0045093 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Prior Therapy Non-Small Cell Lung Carcinoma Advanced | Prior Therapy Non-small cell lung cancer metastatic | Prior Therapy Non-small cell lung cancer recurrent
Item
1. prior therapy for advanced or metastatic or recurrent non small cell lung cancer (nsclc). one prior adjuvant, neoadjuvant or adjuvant + neoadjuvant treatment is allowed if at least 12 months have elapsed between the end of the treatment and randomization
boolean
C1514463 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C0278987 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0278517 (UMLS CUI [3,2])
VEGFR Inhibitor | Exception Bevacizumab
Item
2. prior treatment with other vascular endothelial growth factor receptor (vegfr) inhibitors (other than bevacizumab)
boolean
C2985521 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0796392 (UMLS CUI [2,2])
Medical contraindication Gemcitabine | Medical contraindication Cisplatin
Item
3. any contraindications for treatment with gemcitabine and/or cisplatin.
boolean
C1301624 (UMLS CUI [1,1])
C0045093 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0008838 (UMLS CUI [2,2])
Investigational New Drugs
Item
4. use of any investigational drug within 4 weeks of entering the 1199.82 study.
boolean
C0013230 (UMLS CUI [1])
Hemorrhage Thrombotic Major | Hemorrhage Clinical Relevant
Item
5. history of major thrombotic or clinically relevant bleeding event in the past 6 months.
boolean
C0019080 (UMLS CUI [1,1])
C0087086 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0019080 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C2347946 (UMLS CUI [2,3])
Cardiovascular Diseases | Uncontrolled hypertension
Item
6. significant cardiovascular diseases (i.e. hypertension not controlled by medication.
boolean
C0007222 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
Operative Surgical Procedures | Exception Tumor Biopsy | Wound Healing Incomplete
Item
7. surgery within 4 weeks (except tumour biopsy) prior randomisation and incomplete wound healing.
boolean
C0543467 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0027651 (UMLS CUI [2,2])
C0005558 (UMLS CUI [2,3])
C0043240 (UMLS CUI [3,1])
C0205257 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain
Item
8. active brain metastases
boolean
C0220650 (UMLS CUI [1])
Therapeutic radiology procedure | Exception Extremities | Therapeutic radiology procedure Metastatic malignant neoplasm to brain
Item
9. radiotherapy (except extremities) within 3 months prior to baseline imaging and radiotherapy for brain metastasis < 4 weeks prior baseline imaging.
boolean
C1522449 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015385 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0220650 (UMLS CUI [3,2])
Cancer Other
Item
10. any other current malignancy or malignancy diagnosed within the past five (5) years.
boolean
C1707251 (UMLS CUI [1])