ID

36680

Beschreibung

A Study Evaluating RO5479599 in Combination With Carboplatin and Paclitaxel in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) of Squamous Histology; ODM derived from: https://clinicaltrials.gov/show/NCT02204345

Link

https://clinicaltrials.gov/show/NCT02204345

Stichworte

Versionen (1)
  1. 31.05.19 31.05.19 -
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See clinicaltrials.gov

Hochgeladen am

31. Mai 2019

DOI

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Creative Commons BY 4.0
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Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02204345

Englisch

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02204345

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >/= 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status (ps) 0 - 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
histologically confirmed squamous nsclc patients
Beschreibung

Squamous non-small cell lung cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C4509816
locally advanced or metastatic (stage iiib or iv) squamous nsclc
Beschreibung

Squamous non-small cell lung cancer Advanced Locally TNM clinical staging | Squamous non-small cell lung cancer metastatic TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4509816
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C4509816
UMLS CUI [2,2]
C1522484
UMLS CUI [2,3]
C3258246
no prior systemic chemotherapy, targeted therapy for metastatic nsclc
Beschreibung

Systemic Chemotherapy Absent Non-small cell lung cancer metastatic | Targeted Therapy Absent Non-small cell lung cancer metastatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0278987
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0278987
evidence of at least one radiologically measurable lesion as per response evaluation criteria in solid tumors (recist) version 1.1
Beschreibung

Measurable lesion Quantity Radiology

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0043299
adequate hematological, liver and renal function
Beschreibung

Hematologic function | Liver function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
use of highly effective contraception
Beschreibung

Use of Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent therapy with any other investigational drug
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
history or clinical evidence of central nervous system (cns) primary tumors or metastases
Beschreibung

Central Nervous System Neoplasms, Primary | CNS metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0751620
UMLS CUI [2]
C0686377
evidence of significant, uncontrolled concomitant diseases, which could affect compliance with the protocol or interpretation of results, including uncontrolled diabetes mellitus and/or significant cardiovascular disease or uncontrolled infection
Beschreibung

Comorbidity Uncontrolled Affecting Protocol Compliance | Comorbidity Uncontrolled Affecting Research results | Diabetic - poor control | Cardiovascular Disease | Communicable Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0525058
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0683954
UMLS CUI [3]
C0421258
UMLS CUI [4]
C0007222
UMLS CUI [5,1]
C0009450
UMLS CUI [5,2]
C0205318
any other diseases, metabolic dysfunction, a physical examination finding or a clinical laboratory finding, giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
Beschreibung

Medical contraindication Investigational New Drugs | Etiology Comorbidity | Etiology Dysfunction Metabolic | Etiology Physical Examination | Etiology Laboratory test finding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0009488
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C3887504
UMLS CUI [3,3]
C0311400
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0031809
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C0587081
major surgery or significant traumatic injury < 28 days prior to the first study treatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
Beschreibung

Major surgery | Traumatic injury | Patient need for Major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C3263723
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0679637
pregnant or breast-feeding women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of other malignancies that could affect compliance with protocol or interpretation of results. patients with malignancies diagnosed more than five years prior to study day one, adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer are generally eligible
Beschreibung

Cancer Other Affecting Protocol Compliance | Cancer Other Affecting Interpretation Research results | Exception Malignant Neoplasms Previous | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0459471
UMLS CUI [2,4]
C0683954
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0006826
UMLS CUI [3,3]
C0205156
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007117
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0553723
UMLS CUI [6,3]
C1522326
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Ähnliche Modelle

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02204345

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age >/= 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status (ps) 0 - 1
boolean
C1520224 (UMLS CUI [1])
Squamous non-small cell lung cancer
Item
histologically confirmed squamous nsclc patients
boolean
C4509816 (UMLS CUI [1])
Squamous non-small cell lung cancer Advanced Locally TNM clinical staging | Squamous non-small cell lung cancer metastatic TNM clinical staging
Item
locally advanced or metastatic (stage iiib or iv) squamous nsclc
boolean
C4509816 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C4509816 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
Systemic Chemotherapy Absent Non-small cell lung cancer metastatic | Targeted Therapy Absent Non-small cell lung cancer metastatic
Item
no prior systemic chemotherapy, targeted therapy for metastatic nsclc
boolean
C1883256 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0278987 (UMLS CUI [1,3])
C2985566 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0278987 (UMLS CUI [2,3])
Measurable lesion Quantity Radiology
Item
evidence of at least one radiologically measurable lesion as per response evaluation criteria in solid tumors (recist) version 1.1
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0043299 (UMLS CUI [1,3])
Hematologic function | Liver function | Renal function
Item
adequate hematological, liver and renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Use of Contraceptive methods
Item
use of highly effective contraception
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
concurrent therapy with any other investigational drug
boolean
C0013230 (UMLS CUI [1])
Central Nervous System Neoplasms, Primary | CNS metastases
Item
history or clinical evidence of central nervous system (cns) primary tumors or metastases
boolean
C0751620 (UMLS CUI [1])
C0686377 (UMLS CUI [2])
Comorbidity Uncontrolled Affecting Protocol Compliance | Comorbidity Uncontrolled Affecting Research results | Diabetic - poor control | Cardiovascular Disease | Communicable Disease Uncontrolled
Item
evidence of significant, uncontrolled concomitant diseases, which could affect compliance with the protocol or interpretation of results, including uncontrolled diabetes mellitus and/or significant cardiovascular disease or uncontrolled infection
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C0421258 (UMLS CUI [3])
C0007222 (UMLS CUI [4])
C0009450 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
Medical contraindication Investigational New Drugs | Etiology Comorbidity | Etiology Dysfunction Metabolic | Etiology Physical Examination | Etiology Laboratory test finding
Item
any other diseases, metabolic dysfunction, a physical examination finding or a clinical laboratory finding, giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0009488 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C3887504 (UMLS CUI [3,2])
C0311400 (UMLS CUI [3,3])
C0015127 (UMLS CUI [4,1])
C0031809 (UMLS CUI [4,2])
C0015127 (UMLS CUI [5,1])
C0587081 (UMLS CUI [5,2])
Major surgery | Traumatic injury | Patient need for Major surgery
Item
major surgery or significant traumatic injury < 28 days prior to the first study treatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
boolean
C0679637 (UMLS CUI [1])
C3263723 (UMLS CUI [2])
C0686904 (UMLS CUI [3,1])
C0679637 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer Other Affecting Protocol Compliance | Cancer Other Affecting Interpretation Research results | Exception Malignant Neoplasms Previous | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
history of other malignancies that could affect compliance with protocol or interpretation of results. patients with malignancies diagnosed more than five years prior to study day one, adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer are generally eligible
boolean
C1707251 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C1707251 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0205156 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0007117 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0553723 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
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