ID

27425

Description

A Study Evaluating Dalotuzumab (MK0646) in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer (0646-007); ODM derived from: https://clinicaltrials.gov/show/NCT00654420

Link

https://clinicaltrials.gov/show/NCT00654420

Keywords

Versions (1)
  1. 11/14/17 11/14/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 14, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-small-cell Lung NCT00654420

English

Eligibility Carcinoma, Non-small-cell Lung NCT00654420

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject has locally advanced or metastatic stage iiib/iv non-small cell lung cancer that has relapsed after chemotherapy/chemoratiotherapy.
Description

Non-Small Cell Lung Carcinoma Advanced Local TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging | Chemotherapy | Chemoradiotherapy | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0278987
UMLS CUI [2,2]
C3258246
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0436307
UMLS CUI [5]
C0277556
subject has had at least one chemotherapy regimen for recurrent or metastatic disease.
Description

Chemotherapy Quantity Recurrent disease | Chemotherapy Quantity Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0277556
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0027627
subject is 18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subject has a performance status of 0-2 on ecog scale.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
women of childbearing potential have a negative pregnancy test
Description

Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks
Description

Chemotherapy | Biological treatment | bevacizumab

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1531518
UMLS CUI [3]
C0796392
subject has not recovered from adverse events from previous therapy within 4 weeks
Description

Adverse event Due to Prior Therapy | Recovery Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C2004454
UMLS CUI [2,2]
C0332268
subject has received egfr-tki inhibitor/anti-egfr mab therapy
Description

EGFR-TK inhibitor | Anti-EGFR Antibody

Data type

boolean

Alias
UMLS CUI [1]
C1443775
UMLS CUI [2]
C4055105
subject has received igf1r-tki inhibitor/anti-igf1r mab therapy
Description

IGF1R | Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C0140080
UMLS CUI [2]
C3846158
subject has had more than 2 systemic chemotherapies for metastatic disease
Description

Systemic Chemotherapy Quantity Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
subject has not completed radiotherapy with complete resolution of toxicities at least 2 weeks before starting in the study
Description

Therapeutic radiology procedure Completion Lacking | Toxicity Resolution Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1514893
UMLS CUI [2,3]
C0332268
subject is taking part in another clinical study
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
subject has a primary central nervous system tumor
Description

Central Nervous System Neoplasms, Primary

Data type

boolean

Alias
UMLS CUI [1]
C0751620
subject abuses drugs or alcohol
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
subject is pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subject is hiv positive
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
subject has a history of hepatitis b or c
Description

Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
subject is using growth hormone or growth hormone inhibitors
Description

Growth Hormone | Growth Hormone Receptor Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C0037663
UMLS CUI [2]
C3812146
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Similar models

Eligibility Carcinoma, Non-small-cell Lung NCT00654420

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced Local TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging | Chemotherapy | Chemoradiotherapy | Recurrent disease
Item
subject has locally advanced or metastatic stage iiib/iv non-small cell lung cancer that has relapsed after chemotherapy/chemoratiotherapy.
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3])
C0436307 (UMLS CUI [4])
C0277556 (UMLS CUI [5])
Chemotherapy Quantity Recurrent disease | Chemotherapy Quantity Neoplasm Metastasis
Item
subject has had at least one chemotherapy regimen for recurrent or metastatic disease.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
Age
Item
subject is 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
subject has a performance status of 0-2 on ecog scale.
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
women of childbearing potential have a negative pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Biological treatment | bevacizumab
Item
subject has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks
boolean
C0392920 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0796392 (UMLS CUI [3])
Adverse event Due to Prior Therapy | Recovery Lacking
Item
subject has not recovered from adverse events from previous therapy within 4 weeks
boolean
C0877248 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C2004454 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
EGFR-TK inhibitor | Anti-EGFR Antibody
Item
subject has received egfr-tki inhibitor/anti-egfr mab therapy
boolean
C1443775 (UMLS CUI [1])
C4055105 (UMLS CUI [2])
IGF1R | Other Coding
Item
subject has received igf1r-tki inhibitor/anti-igf1r mab therapy
boolean
C0140080 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
Systemic Chemotherapy Quantity Neoplasm Metastasis
Item
subject has had more than 2 systemic chemotherapies for metastatic disease
boolean
C1883256 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Therapeutic radiology procedure Completion Lacking | Toxicity Resolution Lacking
Item
subject has not completed radiotherapy with complete resolution of toxicities at least 2 weeks before starting in the study
boolean
C1522449 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Study Subject Participation Status
Item
subject is taking part in another clinical study
boolean
C2348568 (UMLS CUI [1])
Central Nervous System Neoplasms, Primary
Item
subject has a primary central nervous system tumor
boolean
C0751620 (UMLS CUI [1])
Substance Use Disorders
Item
subject abuses drugs or alcohol
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
subject is pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity
Item
subject is hiv positive
boolean
C0019699 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
subject has a history of hepatitis b or c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Growth Hormone | Growth Hormone Receptor Inhibitor
Item
subject is using growth hormone or growth hormone inhibitors
boolean
C0037663 (UMLS CUI [1])
C3812146 (UMLS CUI [2])
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