ID

36637

Description

Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0303）; ODM derived from: https://clinicaltrials.gov/show/NCT02388919

Link

https://clinicaltrials.gov/show/NCT02388919

Keywords

Versions (1)
  1. 5/27/19 5/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 27, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT02388919

English

Eligibility Non-small Cell Lung Cancer NCT02388919

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. signed and dated informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. diagnosed with advanced nsclc (phase iiib/iv) through pathology, with measurable nidus(using recist 1.1)
Description

Non-Small Cell Lung Carcinoma Advanced TNM clinical staging | Nidus Measurable

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C1628997
UMLS CUI [2,2]
C1513040
3. at least two systematic chemotherapy with upwards of 3-line treatments or cannot suffer
Description

Systemic Chemotherapy Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C1265611
4. patients must provide detectable specimen (from tumor tissue or hydrothorax) before participating, who negative in egfr&alk can participate or who positive in egfr&alk, have or have not drug tolerance after the treatment with relative targeted drugs
Description

Tumor tissue sample | Hydrothorax Tissue specimen | EGFR Negative | ALK Negative | EGFR Positive | ALK Positive | Tolerance to drug | Tolerance to drug Absent | Status post Targeted Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0475358
UMLS CUI [2,1]
C0020312
UMLS CUI [2,2]
C1292533
UMLS CUI [3,1]
C1414313
UMLS CUI [3,2]
C1513916
UMLS CUI [4]
C4524838
UMLS CUI [5]
C4525189
UMLS CUI [6]
C4290023
UMLS CUI [7]
C0556444
UMLS CUI [8,1]
C0556444
UMLS CUI [8,2]
C0332197
UMLS CUI [9,1]
C0231290
UMLS CUI [9,2]
C2985566
5. ecog ps：0-1,expected survival time: over 3 months
Description

ECOG performance status | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
6. main organs function is normal
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
7. the woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; the man patients who must agree to take contraceptive methods during the research and within another 6 months after it
Description

Childbearing Potential Contraceptive methods | Intrauterine Devices | Contraceptives, Oral | Female Condoms | Breast Feeding Absent | Serum pregnancy test negative | Urine pregnancy test negative | Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0021900
UMLS CUI [3]
C0009905
UMLS CUI [4]
C0221829
UMLS CUI [5,1]
C0006147
UMLS CUI [5,2]
C0332197
UMLS CUI [6]
C0430061
UMLS CUI [7]
C0430057
UMLS CUI [8,1]
C0079399
UMLS CUI [8,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. have used anlotinib before
Description

anlotinib

Data type

boolean

Alias
UMLS CUI [1]
C4519250
2. small cell lung cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
Description

Small cell carcinoma of lung | Carcinoma, Small Cell | Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C0149925
UMLS CUI [2]
C0262584
UMLS CUI [3]
C1707251
3. examined as positive in egfr&alk mutation detection and never take the treatment of tkis
Description

EGFR mutation Positive | ALK mutation Positive | Tyrosine kinase inhibitor Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3266992
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C2825843
UMLS CUI [2,2]
C1514241
UMLS CUI [3,1]
C1268567
UMLS CUI [3,2]
C0332197
4. central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (>50ml/day)
Description

Squamous cell carcinoma of lung | Pleural cavity | Non-Small Cell Lung Carcinoma | Hemoptysis

Data type

boolean

Alias
UMLS CUI [1]
C0149782
UMLS CUI [2]
C0178802
UMLS CUI [3]
C0007131
UMLS CUI [4]
C0019079
5. other kinds of malignancies within 5 years or for now
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
6. plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including cytotoxic therapy, signal transduction inhibitor, and immunotherapy (or who use mitomycin c within 6 weeks before taking the treatment with experimental drug); the patients who have already taken extended field radiotherapy (ef-rt) within 4 weeks before grouping or limited field radiotherapy with proposed assessment of nidus within 2 weeks before grouping
Description

Cancer treatment Systemic Planned | Cytotoxic therapy | Signal Transduction Inhibitor | Immunotherapy | Mitomycin | Extended-Field Radiation Therapy | Therapeutic radiology procedure Radiation Field Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C1301732
UMLS CUI [2]
C0677881
UMLS CUI [3]
C1519313
UMLS CUI [4]
C0021083
UMLS CUI [5]
C0002475
UMLS CUI [6]
C3826855
UMLS CUI [7,1]
C1522449
UMLS CUI [7,2]
C1882536
UMLS CUI [7,3]
C0439801
7. have got non remissive toxic reactions derived from previous therapies, which is over level 1 in ctc ae (4.0), alopecia not included
Description

Toxic reaction Due to Prior Therapy CTCAE Grades | Exception Alopecia

Data type

boolean

Alias
UMLS CUI [1,1]
C0542243
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [1,4]
C1516728
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0002170
8. with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
Description

Factor Affecting Oral medication | Lacking Able to swallow | Gastrointestinal tract excision | Chronic diarrhea | Ileus chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0175795
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2712086
UMLS CUI [3]
C1293479
UMLS CUI [4]
C0401151
UMLS CUI [5,1]
C1258215
UMLS CUI [5,2]
C0205191
9. pleural effusion or ascites, resulting in respiratory syndrome (≥ctc ae level 2)
Description

Pleural effusion disorder CTCAE Grades | Ascites | Respiration Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C1516728
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0035204
10. symptoms of brain metastases cannot be controlled and treated within less than 2 months
Description

Symptoms Metastatic malignant neoplasm to brain Uncontrolled | Symptoms Metastatic malignant neoplasm to brain Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0220650
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0220650
UMLS CUI [2,3]
C0332155
11. get any severe diseases or the ones that cannot be controlled
Description

Disease Severe | Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205318
12. take major surgical treatments, open biopsy, or get overt traumatic injury within 28 days before grouping
Description

Major surgery | Incisional biopsy | Traumatic injury

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0184922
UMLS CUI [3]
C3263723
13. have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding (≥ctcae level 3)
Description

Hemorrhage | Wound, non-healed | Ulcer | Fracture | Hemorrhage and Bleeding Adverse Event CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C0750433
UMLS CUI [3]
C0041582
UMLS CUI [4]
C0016658
UMLS CUI [5,1]
C1556642
UMLS CUI [5,2]
C1516728
14. get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism
Description

Arterial thrombosis | Venous Thrombosis | Cerebrovascular accident | Ischemic stroke Temporary | Deep Vein Thrombosis | Pulmonary Embolism

Data type

boolean

Alias
UMLS CUI [1]
C0151942
UMLS CUI [2]
C0042487
UMLS CUI [3]
C0038454
UMLS CUI [4,1]
C0948008
UMLS CUI [4,2]
C0205374
UMLS CUI [5]
C0149871
UMLS CUI [6]
C0034065
15. ever abuse psychiatric drugs and cannot abstain or who are diagnosed with mental disorder
Description

Pharmaceutical Preparations Psychiatric Abuse | Pharmaceutical Preparations Psychiatric Discontinue Unable | Mental disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205487
UMLS CUI [1,3]
C0013146
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0205487
UMLS CUI [2,3]
C1444662
UMLS CUI [2,4]
C1299582
UMLS CUI [3]
C0004936
16. have participated in other clinical trials of anti-tumor medicine within 4 weeks
Description

Study Subject Participation Status | Antineoplastic Agents

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0003392
17. diagnosed with disease which will severely endanger the security of patients or influence the completion of this research.
Description

Disease High risk Patient safety | Disease Influence Completion of clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C4319571
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C2732579
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Similar models

Eligibility Non-small Cell Lung Cancer NCT02388919

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. signed and dated informed consent
boolean
C0021430 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Advanced TNM clinical staging | Nidus Measurable
Item
2. diagnosed with advanced nsclc (phase iiib/iv) through pathology, with measurable nidus(using recist 1.1)
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C1628997 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
Systemic Chemotherapy Quantity
Item
3. at least two systematic chemotherapy with upwards of 3-line treatments or cannot suffer
boolean
C1883256 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Tumor tissue sample | Hydrothorax Tissue specimen | EGFR Negative | ALK Negative | EGFR Positive | ALK Positive | Tolerance to drug | Tolerance to drug Absent | Status post Targeted Therapy
Item
4. patients must provide detectable specimen (from tumor tissue or hydrothorax) before participating, who negative in egfr&alk can participate or who positive in egfr&alk, have or have not drug tolerance after the treatment with relative targeted drugs
boolean
C0475358 (UMLS CUI [1])
C0020312 (UMLS CUI [2,1])
C1292533 (UMLS CUI [2,2])
C1414313 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C4524838 (UMLS CUI [4])
C4525189 (UMLS CUI [5])
C4290023 (UMLS CUI [6])
C0556444 (UMLS CUI [7])
C0556444 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C0231290 (UMLS CUI [9,1])
C2985566 (UMLS CUI [9,2])
ECOG performance status | Life Expectancy
Item
5. ecog ps：0-1,expected survival time: over 3 months
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Organ function
Item
6. main organs function is normal
boolean
C0678852 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Intrauterine Devices | Contraceptives, Oral | Female Condoms | Breast Feeding Absent | Serum pregnancy test negative | Urine pregnancy test negative | Gender Contraceptive methods
Item
7. the woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; the man patients who must agree to take contraceptive methods during the research and within another 6 months after it
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0021900 (UMLS CUI [2])
C0009905 (UMLS CUI [3])
C0221829 (UMLS CUI [4])
C0006147 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0430061 (UMLS CUI [6])
C0430057 (UMLS CUI [7])
C0079399 (UMLS CUI [8,1])
C0700589 (UMLS CUI [8,2])
Item Group
C0680251 (UMLS CUI)
anlotinib
Item
1. have used anlotinib before
boolean
C4519250 (UMLS CUI [1])
Small cell carcinoma of lung | Carcinoma, Small Cell | Cancer Other
Item
2. small cell lung cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
boolean
C0149925 (UMLS CUI [1])
C0262584 (UMLS CUI [2])
C1707251 (UMLS CUI [3])
EGFR mutation Positive | ALK mutation Positive | Tyrosine kinase inhibitor Absent
Item
3. examined as positive in egfr&alk mutation detection and never take the treatment of tkis
boolean
C3266992 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C2825843 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C1268567 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Squamous cell carcinoma of lung | Pleural cavity | Non-Small Cell Lung Carcinoma | Hemoptysis
Item
4. central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (>50ml/day)
boolean
C0149782 (UMLS CUI [1])
C0178802 (UMLS CUI [2])
C0007131 (UMLS CUI [3])
C0019079 (UMLS CUI [4])
Cancer Other
Item
5. other kinds of malignancies within 5 years or for now
boolean
C1707251 (UMLS CUI [1])
Cancer treatment Systemic Planned | Cytotoxic therapy | Signal Transduction Inhibitor | Immunotherapy | Mitomycin | Extended-Field Radiation Therapy | Therapeutic radiology procedure Radiation Field Limited
Item
6. plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including cytotoxic therapy, signal transduction inhibitor, and immunotherapy (or who use mitomycin c within 6 weeks before taking the treatment with experimental drug); the patients who have already taken extended field radiotherapy (ef-rt) within 4 weeks before grouping or limited field radiotherapy with proposed assessment of nidus within 2 weeks before grouping
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0677881 (UMLS CUI [2])
C1519313 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0002475 (UMLS CUI [5])
C3826855 (UMLS CUI [6])
C1522449 (UMLS CUI [7,1])
C1882536 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
Toxic reaction Due to Prior Therapy CTCAE Grades | Exception Alopecia
Item
7. have got non remissive toxic reactions derived from previous therapies, which is over level 1 in ctc ae (4.0), alopecia not included
boolean
C0542243 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0002170 (UMLS CUI [2,2])
Factor Affecting Oral medication | Lacking Able to swallow | Gastrointestinal tract excision | Chronic diarrhea | Ileus chronic
Item
8. with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
boolean
C1521761 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C2712086 (UMLS CUI [2,2])
C1293479 (UMLS CUI [3])
C0401151 (UMLS CUI [4])
C1258215 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
Pleural effusion disorder CTCAE Grades | Ascites | Respiration Disorders
Item
9. pleural effusion or ascites, resulting in respiratory syndrome (≥ctc ae level 2)
boolean
C0032227 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2])
C0035204 (UMLS CUI [3])
Symptoms Metastatic malignant neoplasm to brain Uncontrolled | Symptoms Metastatic malignant neoplasm to brain Untreated
Item
10. symptoms of brain metastases cannot be controlled and treated within less than 2 months
boolean
C1457887 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
Disease Severe | Disease Uncontrolled
Item
11. get any severe diseases or the ones that cannot be controlled
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Major surgery | Incisional biopsy | Traumatic injury
Item
12. take major surgical treatments, open biopsy, or get overt traumatic injury within 28 days before grouping
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
Hemorrhage | Wound, non-healed | Ulcer | Fracture | Hemorrhage and Bleeding Adverse Event CTCAE Grades
Item
13. have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding (≥ctcae level 3)
boolean
C0019080 (UMLS CUI [1])
C0750433 (UMLS CUI [2])
C0041582 (UMLS CUI [3])
C0016658 (UMLS CUI [4])
C1556642 (UMLS CUI [5,1])
C1516728 (UMLS CUI [5,2])
Arterial thrombosis | Venous Thrombosis | Cerebrovascular accident | Ischemic stroke Temporary | Deep Vein Thrombosis | Pulmonary Embolism
Item
14. get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism
boolean
C0151942 (UMLS CUI [1])
C0042487 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0948008 (UMLS CUI [4,1])
C0205374 (UMLS CUI [4,2])
C0149871 (UMLS CUI [5])
C0034065 (UMLS CUI [6])
Pharmaceutical Preparations Psychiatric Abuse | Pharmaceutical Preparations Psychiatric Discontinue Unable | Mental disorders
Item
15. ever abuse psychiatric drugs and cannot abstain or who are diagnosed with mental disorder
boolean
C0013227 (UMLS CUI [1,1])
C0205487 (UMLS CUI [1,2])
C0013146 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0205487 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
C0004936 (UMLS CUI [3])
Study Subject Participation Status | Antineoplastic Agents
Item
16. have participated in other clinical trials of anti-tumor medicine within 4 weeks
boolean
C2348568 (UMLS CUI [1])
C0003392 (UMLS CUI [2])
Disease High risk Patient safety | Disease Influence Completion of clinical trial
Item
17. diagnosed with disease which will severely endanger the security of patients or influence the completion of this research.
boolean
C0012634 (UMLS CUI [1,1])
C4319571 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
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