ID

35145

Description

A Study of Nab-Paclitaxel and Carboplatin Plus Necitumumab (LY3012211) in Participants With Stage IV Squamous NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT02392507

Link

https://clinicaltrials.gov/show/NCT02392507

Keywords

Versions (1)
  1. 2/19/19 2/19/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 19, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-small-Cell Lung NCT02392507

English

Eligibility Carcinoma, Non-small-Cell Lung NCT02392507

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have histologically or cytologically confirmed squamous nsclc.
Description

Squamous non-small cell lung cancer

Data type

boolean

Alias
UMLS CUI [1]
C4509816
have stage iv disease at the time of study entry (american joint committee on cancer [ajcc] staging manual, 7th edition).
Description

Disease TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
have measurable disease at the time of study enrollment as defined by response evaluation criteria in solid tumors, version 1.1 (recist 1.1).
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
have tumor tissue available for biomarker analysis.
Description

Availability of Tumor tissue sample | Biomarker Analysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [2,1]
C0005516
UMLS CUI [2,2]
C0002778
have an eastern cooperative oncology group (ecog) performance status of 0 to 1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
have adequate organ functions.
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
are currently enrolled in another clinical trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
have received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the epidermal growth factor receptor (egfr), vascular endothelial growth factor (vegf), or vegf receptor.
Description

Cancer treatment | Monoclonal Antibodies | Signal Transduction Inhibitor | Therapy Targeting Epidermal Growth Factor Receptor | Therapy Targeting Vascular Endothelial Growth Factors | Therapy Targeting Vascular Endothelial Growth Factor Receptor

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0003250
UMLS CUI [3]
C1519313
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C1521840
UMLS CUI [4,3]
C0034802
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C1521840
UMLS CUI [5,3]
C1256770
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C1521840
UMLS CUI [6,3]
C0148199
have received previous chemotherapy for advanced nsclc. participants who have received adjuvant or neoadjuvant chemotherapy are eligible if the last administration of the prior regimens occurred at least 1 year prior to study entry.
Description

Prior Chemotherapy Non-Small Cell Lung Carcinoma Advanced

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C0205179
have undergone major surgery or received any investigational therapy in the 4 weeks prior to study entry.
Description

Major surgery | Therapies, Investigational

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0949266
have undergone systemic radiotherapy within 4 weeks prior to study entry, or focal radiotherapy within 2 weeks prior to study entry.
Description

Therapeutic radiology procedure Systemic | Therapeutic radiology procedure Focal

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205234
have symptomatic central nervous system (cns) malignancy or metastasis (screening not required).
Description

Malignant Central Nervous System Neoplasm Symptomatic | CNS metastases Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0348374
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0231220
have a history of arterial or venous embolism within 6 months prior to study entry.
Description

Arterial embolism | Venous embolism

Data type

boolean

Alias
UMLS CUI [1]
C0549124
UMLS CUI [2]
C0340726
have clinical evidence of concomitant infectious conditions.
Description

Communicable/infectious condition

Data type

boolean

Alias
UMLS CUI [1]
C1948090
have a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab, or any other contraindication to one of the administered treatments.
Description

Hypersensitivity Therapeutic procedure Component | Allergic Reaction Therapeutic procedure Component | Hypersensitivity Necitumumab Ingredient | Allergic Reaction Necitumumab Ingredient | Medical contraindication Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C1705248
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2352806
UMLS CUI [3,3]
C1550600
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C2352806
UMLS CUI [4,3]
C1550600
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0087111
are pregnant or breastfeeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
have a known history of drug abuse.
Description

Drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0013146
have a concurrent active malignancy. participants with a history of malignancy are eligible provided the participant has been disease-free for ≥3 years, with the following exception: participants with adequately treated basal or squamous cell carcinoma of the skin, preinvasive carcinoma of the cervix, or any cancer that in the judgment of the investigator and lilly clinical research physician/designee may not affect the interpretation of results (for example, prostate, bladder) are eligible.
Description

Cancer Other | Exception Disease Free Duration | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Prostate carcinoma | Exception Carcinoma of bladder

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
UMLS CUI [2,4]
C0449238
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
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0600139
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0699885
have discontinued investigational product or non approved use of a drug or device from a clinical trial within 30 days before the first day of study treatment.
Description

Investigational New Drug Discontinued | Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1444662
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0013230
UMLS CUI [4]
C2346570
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Similar models

Eligibility Carcinoma, Non-small-Cell Lung NCT02392507

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Squamous non-small cell lung cancer
Item
have histologically or cytologically confirmed squamous nsclc.
boolean
C4509816 (UMLS CUI [1])
Disease TNM clinical staging
Item
have stage iv disease at the time of study entry (american joint committee on cancer [ajcc] staging manual, 7th edition).
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Measurable Disease
Item
have measurable disease at the time of study enrollment as defined by response evaluation criteria in solid tumors, version 1.1 (recist 1.1).
boolean
C1513041 (UMLS CUI [1])
Availability of Tumor tissue sample | Biomarker Analysis
Item
have tumor tissue available for biomarker analysis.
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0005516 (UMLS CUI [2,1])
C0002778 (UMLS CUI [2,2])
ECOG performance status
Item
have an eastern cooperative oncology group (ecog) performance status of 0 to 1.
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
have adequate organ functions.
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
are currently enrolled in another clinical trial.
boolean
C2348568 (UMLS CUI [1])
Cancer treatment | Monoclonal Antibodies | Signal Transduction Inhibitor | Therapy Targeting Epidermal Growth Factor Receptor | Therapy Targeting Vascular Endothelial Growth Factors | Therapy Targeting Vascular Endothelial Growth Factor Receptor
Item
have received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the epidermal growth factor receptor (egfr), vascular endothelial growth factor (vegf), or vegf receptor.
boolean
C0920425 (UMLS CUI [1])
C0003250 (UMLS CUI [2])
C1519313 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C1521840 (UMLS CUI [4,2])
C0034802 (UMLS CUI [4,3])
C0087111 (UMLS CUI [5,1])
C1521840 (UMLS CUI [5,2])
C1256770 (UMLS CUI [5,3])
C0087111 (UMLS CUI [6,1])
C1521840 (UMLS CUI [6,2])
C0148199 (UMLS CUI [6,3])
Prior Chemotherapy Non-Small Cell Lung Carcinoma Advanced
Item
have received previous chemotherapy for advanced nsclc. participants who have received adjuvant or neoadjuvant chemotherapy are eligible if the last administration of the prior regimens occurred at least 1 year prior to study entry.
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
Major surgery | Therapies, Investigational
Item
have undergone major surgery or received any investigational therapy in the 4 weeks prior to study entry.
boolean
C0679637 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Therapeutic radiology procedure Systemic | Therapeutic radiology procedure Focal
Item
have undergone systemic radiotherapy within 4 weeks prior to study entry, or focal radiotherapy within 2 weeks prior to study entry.
boolean
C1522449 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0205234 (UMLS CUI [2,2])
Malignant Central Nervous System Neoplasm Symptomatic | CNS metastases Symptomatic
Item
have symptomatic central nervous system (cns) malignancy or metastasis (screening not required).
boolean
C0348374 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Arterial embolism | Venous embolism
Item
have a history of arterial or venous embolism within 6 months prior to study entry.
boolean
C0549124 (UMLS CUI [1])
C0340726 (UMLS CUI [2])
Communicable/infectious condition
Item
have clinical evidence of concomitant infectious conditions.
boolean
C1948090 (UMLS CUI [1])
Hypersensitivity Therapeutic procedure Component | Allergic Reaction Therapeutic procedure Component | Hypersensitivity Necitumumab Ingredient | Allergic Reaction Necitumumab Ingredient | Medical contraindication Therapeutic procedure
Item
have a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab, or any other contraindication to one of the administered treatments.
boolean
C0020517 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C1527304 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C2352806 (UMLS CUI [3,2])
C1550600 (UMLS CUI [3,3])
C1527304 (UMLS CUI [4,1])
C2352806 (UMLS CUI [4,2])
C1550600 (UMLS CUI [4,3])
C1301624 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
Pregnancy | Breast Feeding
Item
are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Drug abuse
Item
have a known history of drug abuse.
boolean
C0013146 (UMLS CUI [1])
Cancer Other | Exception Disease Free Duration | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Prostate carcinoma | Exception Carcinoma of bladder
Item
have a concurrent active malignancy. participants with a history of malignancy are eligible provided the participant has been disease-free for ≥3 years, with the following exception: participants with adequately treated basal or squamous cell carcinoma of the skin, preinvasive carcinoma of the cervix, or any cancer that in the judgment of the investigator and lilly clinical research physician/designee may not affect the interpretation of results (for example, prostate, bladder) are eligible.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
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])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0600139 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0699885 (UMLS CUI [7,2])
Investigational New Drug Discontinued | Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
have discontinued investigational product or non approved use of a drug or device from a clinical trial within 30 days before the first day of study treatment.
boolean
C0013230 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C2346570 (UMLS CUI [4])
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