ID

38611

Description

CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT01199068

Link

https://clinicaltrials.gov/show/NCT01199068

Keywords

Versions (1)
  1. 10/28/19 10/28/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 28, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT01199068

English

Eligibility Carcinoma, Non-Small-Cell Lung NCT01199068

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed unresectable locally advanced or metastatic (stage iiib or iv) non-small cell lung cancer (nsclc)
Description

Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-Small Cell Lung Carcinoma Advanced Locally unresectable | Non-small cell lung cancer metastatic unresectable TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C1517927
UMLS CUI [2,4]
C1519810
UMLS CUI [3,1]
C0278987
UMLS CUI [3,2]
C1519810
UMLS CUI [3,3]
C3258246
recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first-line platinum based therapy
Description

Recurrent disease | Refractory Disease | Relapse Following Response | Disease Progression | Status post First line treatment Platinum-Based

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1514815
UMLS CUI [3,1]
C0035020
UMLS CUI [3,2]
C0332282
UMLS CUI [3,3]
C1704632
UMLS CUI [4]
C0242656
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C1708063
UMLS CUI [5,3]
C1514162
male or female ≥ 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
anticipation of more than 3 months survival
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
eastern cooperative oncology group performance status (ecog ps) ≤ 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ and bone marrow function
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior tyrosine kinase inhibitor (tki) therapy
Description

Tyrosine kinase inhibitor therapy

Data type

boolean

Alias
UMLS CUI [1]
C0879484
anticipation of need for a major surgical procedure or radiation therapy during the study
Description

Patient need for Major surgery | Patient need for Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0679637
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C1522449
remaining influence of previous therapies such as radiotherapy, surgery, immunotherapy within 4 weeks prior to start of study treatment
Description

Prior Therapy Influence Remaining | Therapeutic radiology procedure Influence Remaining | Operative Surgical Procedure Influence Remaining | Immunotherapy Influence Remaining

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C1527428
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C1527428
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C4054723
UMLS CUI [3,3]
C1527428
UMLS CUI [4,1]
C0021083
UMLS CUI [4,2]
C4054723
UMLS CUI [4,3]
C1527428
treatment with anticancer medication within 4 weeks before study treatment, currently enrolled in another investigational drug study, or enrolled in another investigational drug study within 4 weeks of start of treatment
Description

Antineoplastic Agents | Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0003392
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0013230
history of any of the following events within 6 months prior to start of study treatment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, new york heart association (nyha) class ≥i congestive heart failure (chf), cerebrovascular accident or cerebral infarction, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe chronic-obstructive pulmonary disease (copd) or asthma)
Description

Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral artery bypass | Congestive heart failure New York Heart Association Classification | Cerebrovascular accident | Cerebral Infarction | Pulmonary Embolism | Deep Vein Thrombosis | Thromboembolism | Lung disease Clinical Significance | Severe chronic obstructive pulmonary disease | Severe asthma

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0010055
UMLS CUI [5]
C3495795
UMLS CUI [6,1]
C0018802
UMLS CUI [6,2]
C1275491
UMLS CUI [7]
C0038454
UMLS CUI [8]
C0007785
UMLS CUI [9]
C0034065
UMLS CUI [10]
C0149871
UMLS CUI [11]
C0040038
UMLS CUI [12,1]
C0024115
UMLS CUI [12,2]
C2826293
UMLS CUI [13]
C0730607
UMLS CUI [14]
C0581126
severe edema, ascites fluid, pericardial or pleural effusion or pericardial involvement with the tumor within 6 months prior to start of study treatment, or which require steroid therapy/ diuretic therapy
Description

Edema Severe | Ascites | Pericardial effusion | Pleural effusion | Tumor Involvement Pericardium | Requirement Steroid therapy | Requirement Diuretic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0013604
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0031039
UMLS CUI [4]
C0032227
UMLS CUI [5,1]
C0027651
UMLS CUI [5,2]
C1314939
UMLS CUI [5,3]
C0031050
UMLS CUI [6,1]
C1514873
UMLS CUI [6,2]
C0149783
UMLS CUI [7,1]
C1514873
UMLS CUI [7,2]
C0948575
subjects with brain metastasis (defined as untreated, symptomatic or requiring steroids or anticonvulsant medications to control associated symptoms)
Description

Metastatic malignant neoplasm to brain Untreated | Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Requirement Steroids | Metastatic malignant neoplasm to brain Requirement Anticonvulsants | Metastatic malignant neoplasm to brain Symptom control

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0038317
UMLS CUI [4,1]
C0220650
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0003286
UMLS CUI [5,1]
C0220650
UMLS CUI [5,2]
C1274136
subjects with clinically significant active infection which requires antibiotic therapy, or who are hepatitis b surface antigen (hbsag)-, hepatitis c virus (hcv)- or human immunodeficiency virus (hiv)-positive or receiving antiretroviral therapy
Description

Communicable Disease Requirement Antibiotic therapy | Hepatitis B surface antigen positive | Hepatitis C Virus Positive | HIV Seropositivity | Antiretroviral therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0338237
UMLS CUI [2]
C0149709
UMLS CUI [3]
C4330254
UMLS CUI [4]
C0019699
UMLS CUI [5]
C1963724
subjects with malabsorption syndrome, chronic diarrhea (lasting over 4 weeks), inflammatory bowel disease, or partial bowel obstruction
Description

Malabsorption Syndrome | Chronic diarrhea | Inflammatory Bowel Disease | Partial bowel obstruction

Data type

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2]
C0401151
UMLS CUI [3]
C0021390
UMLS CUI [4]
C1328480
diabetes mellitus requiring insulin, or a history of poor serum glucose control with the use of non-insulin diabetes medications
Description

Diabetes Mellitus Requirement Insulin | Serum glucose Poorly controlled | Antidiabetics Except Insulin

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021641
UMLS CUI [2,1]
C3534430
UMLS CUI [2,2]
C3853134
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C0332300
UMLS CUI [3,3]
C0021641
treatment with thiazolidinedione(tzds) within 4 weeks prior to start of study treatment
Description

Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1]
C1257987
history of a second malignancy, with the exception of in situ cervical cancer or adequately treated basal cell or squamous cell carcinoma of the skin
Description

Second Cancer | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
poorly-controlled blood pressure as judged by the investigator
Description

Blood pressure inadequately controlled

Data type

boolean

Alias
UMLS CUI [1]
C0919892
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT01199068

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-Small Cell Lung Carcinoma Advanced Locally unresectable | Non-small cell lung cancer metastatic unresectable TNM clinical staging
Item
histologically or cytologically confirmed unresectable locally advanced or metastatic (stage iiib or iv) non-small cell lung cancer (nsclc)
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0007131 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C1519810 (UMLS CUI [2,4])
C0278987 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
C3258246 (UMLS CUI [3,3])
Recurrent disease | Refractory Disease | Relapse Following Response | Disease Progression | Status post First line treatment Platinum-Based
Item
recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first-line platinum based therapy
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
C0035020 (UMLS CUI [3,1])
C0332282 (UMLS CUI [3,2])
C1704632 (UMLS CUI [3,3])
C0242656 (UMLS CUI [4])
C0231290 (UMLS CUI [5,1])
C1708063 (UMLS CUI [5,2])
C1514162 (UMLS CUI [5,3])
Age
Item
male or female ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
anticipation of more than 3 months survival
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group performance status (ecog ps) ≤ 1
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
adequate organ and bone marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Tyrosine kinase inhibitor therapy
Item
prior tyrosine kinase inhibitor (tki) therapy
boolean
C0879484 (UMLS CUI [1])
Patient need for Major surgery | Patient need for Therapeutic radiology procedure
Item
anticipation of need for a major surgical procedure or radiation therapy during the study
boolean
C0686904 (UMLS CUI [1,1])
C0679637 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
Prior Therapy Influence Remaining | Therapeutic radiology procedure Influence Remaining | Operative Surgical Procedure Influence Remaining | Immunotherapy Influence Remaining
Item
remaining influence of previous therapies such as radiotherapy, surgery, immunotherapy within 4 weeks prior to start of study treatment
boolean
C1514463 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C1527428 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C1527428 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C4054723 (UMLS CUI [3,2])
C1527428 (UMLS CUI [3,3])
C0021083 (UMLS CUI [4,1])
C4054723 (UMLS CUI [4,2])
C1527428 (UMLS CUI [4,3])
Antineoplastic Agents | Study Subject Participation Status | Investigational New Drugs
Item
treatment with anticancer medication within 4 weeks before study treatment, currently enrolled in another investigational drug study, or enrolled in another investigational drug study within 4 weeks of start of treatment
boolean
C0003392 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral artery bypass | Congestive heart failure New York Heart Association Classification | Cerebrovascular accident | Cerebral Infarction | Pulmonary Embolism | Deep Vein Thrombosis | Thromboembolism | Lung disease Clinical Significance | Severe chronic obstructive pulmonary disease | Severe asthma
Item
history of any of the following events within 6 months prior to start of study treatment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, new york heart association (nyha) class ≥i congestive heart failure (chf), cerebrovascular accident or cerebral infarction, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe chronic-obstructive pulmonary disease (copd) or asthma)
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C3495795 (UMLS CUI [5])
C0018802 (UMLS CUI [6,1])
C1275491 (UMLS CUI [6,2])
C0038454 (UMLS CUI [7])
C0007785 (UMLS CUI [8])
C0034065 (UMLS CUI [9])
C0149871 (UMLS CUI [10])
C0040038 (UMLS CUI [11])
C0024115 (UMLS CUI [12,1])
C2826293 (UMLS CUI [12,2])
C0730607 (UMLS CUI [13])
C0581126 (UMLS CUI [14])
Edema Severe | Ascites | Pericardial effusion | Pleural effusion | Tumor Involvement Pericardium | Requirement Steroid therapy | Requirement Diuretic therapy
Item
severe edema, ascites fluid, pericardial or pleural effusion or pericardial involvement with the tumor within 6 months prior to start of study treatment, or which require steroid therapy/ diuretic therapy
boolean
C0013604 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2])
C0031039 (UMLS CUI [3])
C0032227 (UMLS CUI [4])
C0027651 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
C0031050 (UMLS CUI [5,3])
C1514873 (UMLS CUI [6,1])
C0149783 (UMLS CUI [6,2])
C1514873 (UMLS CUI [7,1])
C0948575 (UMLS CUI [7,2])
Metastatic malignant neoplasm to brain Untreated | Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Requirement Steroids | Metastatic malignant neoplasm to brain Requirement Anticonvulsants | Metastatic malignant neoplasm to brain Symptom control
Item
subjects with brain metastasis (defined as untreated, symptomatic or requiring steroids or anticonvulsant medications to control associated symptoms)
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0038317 (UMLS CUI [3,3])
C0220650 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0003286 (UMLS CUI [4,3])
C0220650 (UMLS CUI [5,1])
C1274136 (UMLS CUI [5,2])
Communicable Disease Requirement Antibiotic therapy | Hepatitis B surface antigen positive | Hepatitis C Virus Positive | HIV Seropositivity | Antiretroviral therapy
Item
subjects with clinically significant active infection which requires antibiotic therapy, or who are hepatitis b surface antigen (hbsag)-, hepatitis c virus (hcv)- or human immunodeficiency virus (hiv)-positive or receiving antiretroviral therapy
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0338237 (UMLS CUI [1,3])
C0149709 (UMLS CUI [2])
C4330254 (UMLS CUI [3])
C0019699 (UMLS CUI [4])
C1963724 (UMLS CUI [5])
Malabsorption Syndrome | Chronic diarrhea | Inflammatory Bowel Disease | Partial bowel obstruction
Item
subjects with malabsorption syndrome, chronic diarrhea (lasting over 4 weeks), inflammatory bowel disease, or partial bowel obstruction
boolean
C0024523 (UMLS CUI [1])
C0401151 (UMLS CUI [2])
C0021390 (UMLS CUI [3])
C1328480 (UMLS CUI [4])
Diabetes Mellitus Requirement Insulin | Serum glucose Poorly controlled | Antidiabetics Except Insulin
Item
diabetes mellitus requiring insulin, or a history of poor serum glucose control with the use of non-insulin diabetes medications
boolean
C0011849 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021641 (UMLS CUI [1,3])
C3534430 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0935929 (UMLS CUI [3,1])
C0332300 (UMLS CUI [3,2])
C0021641 (UMLS CUI [3,3])
Thiazolidinediones
Item
treatment with thiazolidinedione(tzds) within 4 weeks prior to start of study treatment
boolean
C1257987 (UMLS CUI [1])
Second Cancer | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
history of a second malignancy, with the exception of in situ cervical cancer or adequately treated basal cell or squamous cell carcinoma of the skin
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Blood pressure inadequately controlled
Item
poorly-controlled blood pressure as judged by the investigator
boolean
C0919892 (UMLS CUI [1])
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