ID

35100

Description

INCB039110 in Combination With Erlotinib in Non Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations; ODM derived from: https://clinicaltrials.gov/show/NCT02355431

Link

https://clinicaltrials.gov/show/NCT02355431

Keywords

Versions (1)
  1. 2/16/19 2/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 16, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma NCT02355431

English

Eligibility Carcinoma NCT02355431

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT02355431
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed diagnosis of nonsquamous nsclc that is stage iiib, stage iv, or recurrent (including stage ii).
Description

Non-squamous non-small cell lung cancer TNM clinical staging | Non-squamous non-small cell lung cancer Recurrent TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C4324656
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C4324656
UMLS CUI [2,2]
C2945760
UMLS CUI [2,3]
C3258246
documented evidence of an activating mutation in egfr in tumor samples (exon 19 deletions or point mutation l858r in exon 21 or point mutations at codon 719).
Description

EGFR Activating Mutation Tumor tissue sample | EGFR exon 19 deletion | Point mutation in exon 21 (L858R) | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C2984891
UMLS CUI [1,2]
C0475358
UMLS CUI [2]
C3889117
UMLS CUI [3]
C3888903
UMLS CUI [4]
C3846158
a mgps of 1 or 2 as defined below:
Description

Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C3846158
criteria: c-reactive protein >10 mg/l and albumin ≥35 g/l score-1
Description

C-reactive protein measurement | Albumin measurement | Score

Data type

boolean

Alias
UMLS CUI [1]
C0201657
UMLS CUI [2]
C0201838
UMLS CUI [3]
C0449820
criteria: c-reactive protein >10 mg l and albumin <35 g/l score-2
Description

C-reactive protein measurement | Albumin measurement | Score

Data type

boolean

Alias
UMLS CUI [1]
C0201657
UMLS CUI [2]
C0201838
UMLS CUI [3]
C0449820
radiographically measurable or evaluable disease.
Description

Measurable Disease Radiography | Evaluable Disease Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0034571
UMLS CUI [2,1]
C1516986
UMLS CUI [2,2]
C0034571
life expectancy of at least 12 weeks.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
eastern cooperative oncology group (ecog) performance status of 0 to 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit.
Description

Renal function | Liver function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known presence of the t790m mutation in egfr in tumor samples
Description

EGFR T790M Mutation Tumor tissue sample

Data type

boolean

Alias
UMLS CUI [1,1]
C3274192
UMLS CUI [1,2]
C0026882
UMLS CUI [1,3]
C0475358
candidates for curative radiation therapy or surgery.
Description

Therapeutic radiology procedure Curative | Curative Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1276305
UMLS CUI [2]
C1511562
previous systemic chemotherapy for advanced disease, including egfr inhibitor therapy, except subjects who received 1 cycle of chemotherapy while waiting to receive egfr results, who may enroll provided that 21 days have elapsed from end of chemotherapy to the day to the baseline radiographic measurement prior to cycle 1 day 1.
Description

Systemic Chemotherapy Advanced disease | EGFR inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0679246
UMLS CUI [2]
C1443775
distinct or suspected, or history of, pulmonary fibrosis or ild.
Description

Pulmonary Fibrosis | Lung Disease, Interstitial | Pulmonary Fibrosis Suspected | Interstitial Lung Disease Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0034069
UMLS CUI [2]
C0206062
UMLS CUI [3,1]
C0034069
UMLS CUI [3,2]
C0750491
UMLS CUI [4,1]
C0206062
UMLS CUI [4,2]
C0750491
current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive indolent or stage i malignancy without sponsor approval.
Description

Cancer Other | Exception Basal cell carcinoma Cured | Exception Squamous cell carcinoma of skin Cured | Exception Superficial carcinoma of urinary bladder | Exception Prostatic Intraepithelial Neoplasias | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1880198
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1336527
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0282612
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0851140
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0006826
UMLS CUI [7,3]
C3258246
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Similar models

Eligibility Carcinoma NCT02355431

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT02355431
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-squamous non-small cell lung cancer TNM clinical staging | Non-squamous non-small cell lung cancer Recurrent TNM clinical staging
Item
histologically or cytologically confirmed diagnosis of nonsquamous nsclc that is stage iiib, stage iv, or recurrent (including stage ii).
boolean
C4324656 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C4324656 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
EGFR Activating Mutation Tumor tissue sample | EGFR exon 19 deletion | Point mutation in exon 21 (L858R) | Other Coding
Item
documented evidence of an activating mutation in egfr in tumor samples (exon 19 deletions or point mutation l858r in exon 21 or point mutations at codon 719).
boolean
C2984891 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C3889117 (UMLS CUI [2])
C3888903 (UMLS CUI [3])
C3846158 (UMLS CUI [4])
Other Coding
Item
a mgps of 1 or 2 as defined below:
boolean
C3846158 (UMLS CUI [1])
C-reactive protein measurement | Albumin measurement | Score
Item
criteria: c-reactive protein >10 mg/l and albumin ≥35 g/l score-1
boolean
C0201657 (UMLS CUI [1])
C0201838 (UMLS CUI [2])
C0449820 (UMLS CUI [3])
C-reactive protein measurement | Albumin measurement | Score
Item
criteria: c-reactive protein >10 mg l and albumin <35 g/l score-2
boolean
C0201657 (UMLS CUI [1])
C0201838 (UMLS CUI [2])
C0449820 (UMLS CUI [3])
Measurable Disease Radiography | Evaluable Disease Radiography
Item
radiographically measurable or evaluable disease.
boolean
C1513041 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C1516986 (UMLS CUI [2,1])
C0034571 (UMLS CUI [2,2])
Life Expectancy
Item
life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 to 2.
boolean
C1520224 (UMLS CUI [1])
Renal function | Liver function | Bone Marrow function
Item
adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit.
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
EGFR T790M Mutation Tumor tissue sample
Item
known presence of the t790m mutation in egfr in tumor samples
boolean
C3274192 (UMLS CUI [1,1])
C0026882 (UMLS CUI [1,2])
C0475358 (UMLS CUI [1,3])
Therapeutic radiology procedure Curative | Curative Surgery
Item
candidates for curative radiation therapy or surgery.
boolean
C1522449 (UMLS CUI [1,1])
C1276305 (UMLS CUI [1,2])
C1511562 (UMLS CUI [2])
Systemic Chemotherapy Advanced disease | EGFR inhibitor
Item
previous systemic chemotherapy for advanced disease, including egfr inhibitor therapy, except subjects who received 1 cycle of chemotherapy while waiting to receive egfr results, who may enroll provided that 21 days have elapsed from end of chemotherapy to the day to the baseline radiographic measurement prior to cycle 1 day 1.
boolean
C1883256 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
C1443775 (UMLS CUI [2])
Pulmonary Fibrosis | Lung Disease, Interstitial | Pulmonary Fibrosis Suspected | Interstitial Lung Disease Suspected
Item
distinct or suspected, or history of, pulmonary fibrosis or ild.
boolean
C0034069 (UMLS CUI [1])
C0206062 (UMLS CUI [2])
C0034069 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0206062 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Cancer Other | Exception Basal cell carcinoma Cured | Exception Squamous cell carcinoma of skin Cured | Exception Superficial carcinoma of urinary bladder | Exception Prostatic Intraepithelial Neoplasias | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm TNM clinical staging
Item
current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive indolent or stage i malignancy without sponsor approval.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1880198 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1336527 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0282612 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0851140 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0006826 (UMLS CUI [7,2])
C3258246 (UMLS CUI [7,3])
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