ID

36287

Description

Intermittent and Maintenance of Erlotinib in Combination With Pemetrexed/Carboplatin in Ⅲb/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation; ODM derived from: https://clinicaltrials.gov/show/NCT02066038

Link

https://clinicaltrials.gov/show/NCT02066038

Keywords

Versions (1)
  1. 4/29/19 4/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 29, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Lung, Carcinoma NCT02066038

English

Eligibility Lung, Carcinoma NCT02066038

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients between 18 and 75 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
present with histologically proven or cytological diagnosis of non-squamous nsclc stage iiib or iv as defined by the american joint committee on cancer staging criteria for lung cancer, that is not amenable to curative therapy,such as surgery or radiotherapy and so on.
Description

Non-squamous non-small cell lung cancer TNM clinical staging | Curative treatment Unsuccessful | Operative Surgical Procedures Unsuccessful | Therapeutic radiology procedure Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C4324656
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C1273390
UMLS CUI [2,2]
C1272705
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C1272705
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C1272705
no prior systemic chemotherapy or targeted therapy for lung cancer before screening.
Description

Systemic Chemotherapy Absent Carcinoma of lung | Targeted Therapy Absent Carcinoma of lung

Data type

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0684249
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0684249
confirmed activating mutation of egfr—ie, an exon 19 deletion or an exon 21 l858r point mutation.
Description

EGFR Activating Mutation | EGFR exon 19 deletion | Point mutation in exon 21 (L858R)

Data type

boolean

Alias
UMLS CUI [1]
C2984891
UMLS CUI [2]
C3889117
UMLS CUI [3]
C3888903
eastern cooperative oncology group(ecog) performance status of 0 or 1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function.
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
prior radiation therapy allowed to <25% of the bone marrow . prior radiation to the whole pelvis is not allowed. prior radiotherapy must be completed at least 4 weeks before study enrollment. patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
Description

Prior radiation therapy Bone Marrow Percentage | Prior radiation therapy Absent Whole-Pelvis | Prior radiation therapy Completed | Toxicity Due to Prior radiation therapy | Patient recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C3827467
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0205197
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0279134
UMLS CUI [5]
C1115804
signed informed consent document on file.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
estimated life expectancy of ≥12 weeks.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patient compliance and geographic proximity that allow adequate follow up.
Description

Compliance behavior Follow-up | Geographic Location allowing Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C3274571
UMLS CUI [2,1]
C0017446
UMLS CUI [2,2]
C0683607
UMLS CUI [2,3]
C3274571
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known severe hypersensitivity to erlotinib.
Description

Severe allergy Erlotinib

Data type

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C1135135
patients with uncontrolled brain metastasis.
Description

Metastatic malignant neoplasm to brain Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205318
pleural effusion or pericardiac effusion that cannot be controlled by drainage or other procedures.
Description

Drainage Unsuccessful Pleural effusion | Drainage Unsuccessful Cardiac effusion | Procedures Other Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0013103
UMLS CUI [1,2]
C1272705
UMLS CUI [1,3]
C0032227
UMLS CUI [2,1]
C0013103
UMLS CUI [2,2]
C1272705
UMLS CUI [2,3]
C1399211
UMLS CUI [3,1]
C0184661
UMLS CUI [3,2]
C0205394
UMLS CUI [3,3]
C1272705
inability to comply with protocol or study procedures.
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
a serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
Description

Comorbidity Systemic Serious | Completion of clinical trial At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0205404
UMLS CUI [2,1]
C2732579
UMLS CUI [2,2]
C1444641
a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
Description

Condition Cardiac Serious | Myocardial Infarction | Angina Pectoris | Heart Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0205404
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002962
UMLS CUI [4]
C0018799
second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
Description

Second Primary Cancer

Data type

boolean

Alias
UMLS CUI [1]
C0751623
interstitial pneumonia.
Description

Pneumonia, Interstitial

Data type

boolean

Alias
UMLS CUI [1]
C0206061
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Similar models

Eligibility Lung, Carcinoma NCT02066038

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients between 18 and 75 years of age.
boolean
C0001779 (UMLS CUI [1])
Non-squamous non-small cell lung cancer TNM clinical staging | Curative treatment Unsuccessful | Operative Surgical Procedures Unsuccessful | Therapeutic radiology procedure Unsuccessful
Item
present with histologically proven or cytological diagnosis of non-squamous nsclc stage iiib or iv as defined by the american joint committee on cancer staging criteria for lung cancer, that is not amenable to curative therapy,such as surgery or radiotherapy and so on.
boolean
C4324656 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1273390 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
Systemic Chemotherapy Absent Carcinoma of lung | Targeted Therapy Absent Carcinoma of lung
Item
no prior systemic chemotherapy or targeted therapy for lung cancer before screening.
boolean
C1883256 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0684249 (UMLS CUI [1,3])
C2985566 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0684249 (UMLS CUI [2,3])
EGFR Activating Mutation | EGFR exon 19 deletion | Point mutation in exon 21 (L858R)
Item
confirmed activating mutation of egfr—ie, an exon 19 deletion or an exon 21 l858r point mutation.
boolean
C2984891 (UMLS CUI [1])
C3889117 (UMLS CUI [2])
C3888903 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group(ecog) performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
adequate organ function.
boolean
C0678852 (UMLS CUI [1])
Prior radiation therapy Bone Marrow Percentage | Prior radiation therapy Absent Whole-Pelvis | Prior radiation therapy Completed | Toxicity Due to Prior radiation therapy | Patient recovered
Item
prior radiation therapy allowed to <25% of the bone marrow . prior radiation to the whole pelvis is not allowed. prior radiotherapy must be completed at least 4 weeks before study enrollment. patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
boolean
C0279134 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3827467 (UMLS CUI [2,3])
C0279134 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0600688 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0279134 (UMLS CUI [4,3])
C1115804 (UMLS CUI [5])
Informed Consent
Item
signed informed consent document on file.
boolean
C0021430 (UMLS CUI [1])
Life Expectancy
Item
estimated life expectancy of ≥12 weeks.
boolean
C0023671 (UMLS CUI [1])
Compliance behavior Follow-up | Geographic Location allowing Follow-up
Item
patient compliance and geographic proximity that allow adequate follow up.
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0017446 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Severe allergy Erlotinib
Item
known severe hypersensitivity to erlotinib.
boolean
C2945656 (UMLS CUI [1,1])
C1135135 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Uncontrolled
Item
patients with uncontrolled brain metastasis.
boolean
C0220650 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Drainage Unsuccessful Pleural effusion | Drainage Unsuccessful Cardiac effusion | Procedures Other Unsuccessful
Item
pleural effusion or pericardiac effusion that cannot be controlled by drainage or other procedures.
boolean
C0013103 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C0032227 (UMLS CUI [1,3])
C0013103 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C1399211 (UMLS CUI [2,3])
C0184661 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
Protocol Compliance Unable
Item
inability to comply with protocol or study procedures.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Comorbidity Systemic Serious | Completion of clinical trial At risk
Item
a serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
boolean
C0009488 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C2732579 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
Condition Cardiac Serious | Myocardial Infarction | Angina Pectoris | Heart Disease
Item
a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
boolean
C0348080 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0027051 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
Second Primary Cancer
Item
second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
boolean
C0751623 (UMLS CUI [1])
Pneumonia, Interstitial
Item
interstitial pneumonia.
boolean
C0206061 (UMLS CUI [1])
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