ID

41191

Beschreibung

Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung); ODM derived from: https://clinicaltrials.gov/show/NCT02134015

Link

https://clinicaltrials.gov/show/NCT02134015

Stichworte

Versionen (1)
  1. 10.07.20 10.07.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

10. Juli 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT02134015

Englisch

Eligibility Lung Cancer NCT02134015

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. must be greater or equal to 20 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. must have cytologically or histologically confirmed nsclc with either:
Beschreibung

Non-Small Cell Lung Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
metastatic disease (stage iv) or
Beschreibung

Neoplasm Metastasis TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C3258246
stage iiib disease not amenable to surgery or curative intent.
Beschreibung

Disease TNM clinical staging | Disease Inappropriate Operative Surgical Procedure | Disease Inappropriate Curative - procedure intent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0543467
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C1276305
note: it is permissible to use either ajcc version 6.0 or the ajcc version 7.0 staging system. for sites that use ajcc version 7.0, t4m0 patients with other ipsilateral nodules and n0-n2 are still eligible.
Beschreibung

TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1]
C3258246
3. if tumor histology is adenocarcinoma, must have wild-type egfr genotype as assessed by a validated assay that includes exon 19 deletion and exon 21 (l858r) substitution.
Beschreibung

Adenocarcinoma | EGFR gene Wild Type | EGFR exon 19 deletion | EGFR Exon 21 Mutation

Datentyp

boolean

Alias
UMLS CUI [1]
C0001418
UMLS CUI [2,1]
C1414313
UMLS CUI [2,2]
C1883559
UMLS CUI [3]
C3889117
UMLS CUI [4]
C4289654
4. must have received one or two prior lines of systemic chemotherapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy.
Beschreibung

Systemic Chemotherapy Quantity Advanced disease | Systemic Chemotherapy Quantity Neoplasm Metastasis | Platinum Doublet

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0679246
UMLS CUI [2,1]
C1883256
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0027627
UMLS CUI [3]
C5206469
5. must have disease progression or recurrence documented by radiographic assessment following treatment after last chemotherapy or chemoradiation regimen (completed within the previous 12 months).
Beschreibung

Disease Progression | Disease recurrence | Status post Chemotherapy | Status post Chemoradiotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0679254
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0392920
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0436307
6. must have available recent (before treatment start) or archival tumor specimen.
Beschreibung

Availability of Tumor tissue sample

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
7. must have measurable disease for part a, measurable disease or non-measurable disease for part b
Beschreibung

Measurable Disease | Non-Measurable Lesion

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1334988
8. must have eastern cooperative oncology group (ecog) performance status of 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
9. must have adequate hematological function
Beschreibung

Hematologic function

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
10. must have adequate renal function
Beschreibung

Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
11. must have adequate hepatic function
Beschreibung

Liver function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
12. agreement to use effective contraception while on treatment and for at least 6 months after end of treatment
Beschreibung

Agreement Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C0700589
13. must have provided informed consent for study participation.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. lung adenocarcinoma with an anaplastic lymphoma kinase (alk) gene rearrangement
Beschreibung

Adenocarcinoma of lung | ALK Gene Rearrangement

Datentyp

boolean

Alias
UMLS CUI [1]
C0152013
UMLS CUI [2]
C4068350
2. left ventricular ejection fraction (lvef) less than 45%
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
3. prior egfr-targeted regimen, anti-her2, anti-her3, or anti-her4 therapy
Beschreibung

EGFR targeted therapy | Targeted Therapy HER2 | Targeted Therapy HER3 | Targeted Therapy HER4

Datentyp

boolean

Alias
UMLS CUI [1]
C4733187
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C0069515
UMLS CUI [3,1]
C2985566
UMLS CUI [3,2]
C0812265
UMLS CUI [4,1]
C2985566
UMLS CUI [4,2]
C0812267
4. history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for greater or equal to 5 years
Beschreibung

Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Curative treatment Disease In situ | Exception Curative treatment Solid Neoplasm | Exception Disease Free Duration

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0012634
UMLS CUI [3,4]
C0444498
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0280100
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
5. history of corneal disease
Beschreibung

Corneal Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0010034
6. history of interstitial lung disease (ild)
Beschreibung

Lung Disease, Interstitial

Datentyp

boolean

Alias
UMLS CUI [1]
C0206062
7. clinically active brain metastases
Beschreibung

Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
8. uncontrolled hypertension
Beschreibung

Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
9. clinically significant ecg changes
Beschreibung

ECG changes Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0855329
UMLS CUI [1,2]
C2826293
10. clinically significant (in the opinion of the investigator) ascites or pleural effusion requiring chronic medical intervention
Beschreibung

Ascites | Pleural effusion | Requirement Intervention chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0003962
UMLS CUI [2]
C0032227
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0184661
UMLS CUI [3,3]
C0205191
11. myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or unstable cardiac arrhythmia requiring medication
Beschreibung

Myocardial Infarction | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia Unstable | Requirement Pharmaceutical Preparations

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0742758
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C0013227
12. treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 4 weeks before study drug treatment
Beschreibung

Cancer treatment | Antibody Therapy | Retinoid therapy of cancer | Hormone Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0281176
UMLS CUI [3]
C0598926
UMLS CUI [4]
C0279025
13. therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment; or palliative radiation within 2 weeks before study drug treatment
Beschreibung

Therapeutic radiology procedure | Major surgery | Palliative course of radiotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0679637
UMLS CUI [3]
C0475092
14. participation in clinical drug trials within 4 weeks
Beschreibung

Study Subject Participation Status | Clinical Trial | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3]
C0013230
15. uncontrolled infection requiring iv antibiotics, antivirals, or antifungals, known human immunodeficiency virus (hiv) infection, or active hepatitis b or c infection.
Beschreibung

Communicable Disease Uncontrolled | Requirement Antibiotics Intravenous | Requirement Antiviral Agents | Requirement Antifungal Agents | HIV Infection | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0003232
UMLS CUI [2,3]
C1522726
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0003451
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0003308
UMLS CUI [5]
C0019693
UMLS CUI [6]
C0019163
UMLS CUI [7]
C0019196
16. history of hypersensitivity to any of the study drugs or to any excipients.
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
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Ähnliche Modelle

Eligibility Lung Cancer NCT02134015

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. must be greater or equal to 20 years of age
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma
Item
2. must have cytologically or histologically confirmed nsclc with either:
boolean
C0007131 (UMLS CUI [1])
Neoplasm Metastasis TNM clinical staging
Item
metastatic disease (stage iv) or
boolean
C0027627 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Disease TNM clinical staging | Disease Inappropriate Operative Surgical Procedure | Disease Inappropriate Curative - procedure intent
Item
stage iiib disease not amenable to surgery or curative intent.
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C1276305 (UMLS CUI [3,3])
TNM clinical staging
Item
note: it is permissible to use either ajcc version 6.0 or the ajcc version 7.0 staging system. for sites that use ajcc version 7.0, t4m0 patients with other ipsilateral nodules and n0-n2 are still eligible.
boolean
C3258246 (UMLS CUI [1])
Adenocarcinoma | EGFR gene Wild Type | EGFR exon 19 deletion | EGFR Exon 21 Mutation
Item
3. if tumor histology is adenocarcinoma, must have wild-type egfr genotype as assessed by a validated assay that includes exon 19 deletion and exon 21 (l858r) substitution.
boolean
C0001418 (UMLS CUI [1])
C1414313 (UMLS CUI [2,1])
C1883559 (UMLS CUI [2,2])
C3889117 (UMLS CUI [3])
C4289654 (UMLS CUI [4])
Systemic Chemotherapy Quantity Advanced disease | Systemic Chemotherapy Quantity Neoplasm Metastasis | Platinum Doublet
Item
4. must have received one or two prior lines of systemic chemotherapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy.
boolean
C1883256 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
C1883256 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C5206469 (UMLS CUI [3])
Disease Progression | Disease recurrence | Status post Chemotherapy | Status post Chemoradiotherapy
Item
5. must have disease progression or recurrence documented by radiographic assessment following treatment after last chemotherapy or chemoradiation regimen (completed within the previous 12 months).
boolean
C0242656 (UMLS CUI [1])
C0679254 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0436307 (UMLS CUI [4,2])
Availability of Tumor tissue sample
Item
6. must have available recent (before treatment start) or archival tumor specimen.
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
Measurable Disease | Non-Measurable Lesion
Item
7. must have measurable disease for part a, measurable disease or non-measurable disease for part b
boolean
C1513041 (UMLS CUI [1])
C1334988 (UMLS CUI [2])
ECOG performance status
Item
8. must have eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Hematologic function
Item
9. must have adequate hematological function
boolean
C0221130 (UMLS CUI [1])
Renal function
Item
10. must have adequate renal function
boolean
C0232804 (UMLS CUI [1])
Liver function
Item
11. must have adequate hepatic function
boolean
C0232741 (UMLS CUI [1])
Agreement Contraceptive methods
Item
12. agreement to use effective contraception while on treatment and for at least 6 months after end of treatment
boolean
C0680240 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
13. must have provided informed consent for study participation.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Adenocarcinoma of lung | ALK Gene Rearrangement
Item
1. lung adenocarcinoma with an anaplastic lymphoma kinase (alk) gene rearrangement
boolean
C0152013 (UMLS CUI [1])
C4068350 (UMLS CUI [2])
Left ventricular ejection fraction
Item
2. left ventricular ejection fraction (lvef) less than 45%
boolean
C0428772 (UMLS CUI [1])
EGFR targeted therapy | Targeted Therapy HER2 | Targeted Therapy HER3 | Targeted Therapy HER4
Item
3. prior egfr-targeted regimen, anti-her2, anti-her3, or anti-her4 therapy
boolean
C4733187 (UMLS CUI [1])
C2985566 (UMLS CUI [2,1])
C0069515 (UMLS CUI [2,2])
C2985566 (UMLS CUI [3,1])
C0812265 (UMLS CUI [3,2])
C2985566 (UMLS CUI [4,1])
C0812267 (UMLS CUI [4,2])
Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Curative treatment Disease In situ | Exception Curative treatment Solid Neoplasm | Exception Disease Free Duration
Item
4. history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for greater or equal to 5 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0012634 (UMLS CUI [3,3])
C0444498 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0280100 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
Corneal Disease
Item
5. history of corneal disease
boolean
C0010034 (UMLS CUI [1])
Lung Disease, Interstitial
Item
6. history of interstitial lung disease (ild)
boolean
C0206062 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
7. clinically active brain metastases
boolean
C0220650 (UMLS CUI [1])
Uncontrolled hypertension
Item
8. uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
ECG changes Clinical Significance
Item
9. clinically significant ecg changes
boolean
C0855329 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Ascites | Pleural effusion | Requirement Intervention chronic
Item
10. clinically significant (in the opinion of the investigator) ascites or pleural effusion requiring chronic medical intervention
boolean
C0003962 (UMLS CUI [1])
C0032227 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C0205191 (UMLS CUI [3,3])
Myocardial Infarction | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia Unstable | Requirement Pharmaceutical Preparations
Item
11. myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or unstable cardiac arrhythmia requiring medication
boolean
C0027051 (UMLS CUI [1])
C0742758 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C1514873 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
Cancer treatment | Antibody Therapy | Retinoid therapy of cancer | Hormone Therapy
Item
12. treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 4 weeks before study drug treatment
boolean
C0920425 (UMLS CUI [1])
C0281176 (UMLS CUI [2])
C0598926 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
Therapeutic radiology procedure | Major surgery | Palliative course of radiotherapy
Item
13. therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment; or palliative radiation within 2 weeks before study drug treatment
boolean
C1522449 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
C0475092 (UMLS CUI [3])
Study Subject Participation Status | Clinical Trial | Investigational New Drugs
Item
14. participation in clinical drug trials within 4 weeks
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Communicable Disease Uncontrolled | Requirement Antibiotics Intravenous | Requirement Antiviral Agents | Requirement Antifungal Agents | HIV Infection | Hepatitis B | Hepatitis C
Item
15. uncontrolled infection requiring iv antibiotics, antivirals, or antifungals, known human immunodeficiency virus (hiv) infection, or active hepatitis b or c infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0003232 (UMLS CUI [2,2])
C1522726 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0003451 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0003308 (UMLS CUI [4,2])
C0019693 (UMLS CUI [5])
C0019163 (UMLS CUI [6])
C0019196 (UMLS CUI [7])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient
Item
16. history of hypersensitivity to any of the study drugs or to any excipients.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
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