ID

36632

Descripción

ALEX Study: A Randomized, Phase III Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02075840

Link

https://clinicaltrials.gov/show/NCT02075840

Palabras clave

Versiones (1)
  1. 27/5/19 27/5/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

27 de mayo de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT02075840

Inglés

Eligibility Non-Small Cell Lung Cancer NCT02075840

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed diagnosis of advanced or recurrent (stage iiib not amenable for multimodality treatment) or metastatic (stage iv) nsclc that is alk-positive as assessed by the ventana ihc test
Descripción

Non-Small Cell Lung Carcinoma Advanced ALK Positive TNM clinical staging | Non-small cell lung cancer recurrent ALK Positive TNM clinical staging | Disease Inappropriate Multimodality cancer therapy | Non-small cell lung cancer metastatic ALK Positive TNM clinical staging | ALK Positive Immunohistochemistry

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C4290023
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0278517
UMLS CUI [2,2]
C4290023
UMLS CUI [2,3]
C3258246
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C0920596
UMLS CUI [4,1]
C0278987
UMLS CUI [4,2]
C4290023
UMLS CUI [4,3]
C3258246
UMLS CUI [5,1]
C4290023
UMLS CUI [5,2]
C0021044
age >/= 18 years old
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy of at least 12 weeks
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
ecog ps of 0-2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
patients had no prior systemic treatment for advanced or recurrent (stage iiib not amenable for multimodality treatment) or metastatic (stage iv) nsclc
Descripción

Systemic therapy Absent | Non-Small Cell Lung Carcinoma Advanced TNM clinical staging | Non-small cell lung cancer recurrent TNM clinical staging | Disease Inappropriate Multimodality cancer therapy | Non-small cell lung cancer metastatic TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C3258246
UMLS CUI [3,1]
C0278517
UMLS CUI [3,2]
C3258246
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C0920596
UMLS CUI [5,1]
C0278987
UMLS CUI [5,2]
C3258246
adequate renal, hematologic and liver function
Descripción

Renal function | Hematologic function | Liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0221130
UMLS CUI [3]
C0232741
patients must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
Descripción

Effect Due to Major surgery | Effect Due to Traumatic injury | Patient recovered

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1280500
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0679637
UMLS CUI [2,1]
C1280500
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C3263723
UMLS CUI [3]
C1115804
measurable disease (by recist v1.1) prior to the administration of study treatment
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
prior brain or leptomeningeal metastases allowed if asymptomatic (e.g., diagnosed incidentally at study baseline). asymptomatic cns lesions might be treated at the discretion of the investigator per local clinical practice. if patients have neurological symptoms or signs due to cns metastasis, patients need to complete whole brain radiation or gamma knife irradiation treatment. in all cases, radiation treatment must be completed at least 14 days before enrollment and patients must be clinically stable
Descripción

Metastatic malignant neoplasm to brain Asymptomatic | Metastatic Malignant Neoplasm to the Leptomeninges Asymptomatic | Central nervous system lesion Asymptomatic Treated | Neurologic Symptoms CNS metastases | Neurologic Signs CNS metastases | Patient need for Whole brain radiation therapy Complete | Patient need for Gamma knife radiotherapy | Therapeutic radiology procedure Complete | Patient Clinical status Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231221
UMLS CUI [2,1]
C1704231
UMLS CUI [2,2]
C0231221
UMLS CUI [3,1]
C0742468
UMLS CUI [3,2]
C0231221
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C0235031
UMLS CUI [4,2]
C0686377
UMLS CUI [5,1]
C0751378
UMLS CUI [5,2]
C0686377
UMLS CUI [6,1]
C0686904
UMLS CUI [6,2]
C1520143
UMLS CUI [6,3]
C0205197
UMLS CUI [7,1]
C0686904
UMLS CUI [7,2]
C2075822
UMLS CUI [8,1]
C1522449
UMLS CUI [8,2]
C0205197
UMLS CUI [9,1]
C0030705
UMLS CUI [9,2]
C0449440
UMLS CUI [9,3]
C0205360
use of highly effective contraception as defined by the study protocol
Descripción

Use of Contraceptive methods | Contraceptive methods Defined Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C1704788
UMLS CUI [2,3]
C2348563
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a previous malignancy within the past 3 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal (gi) cancer by endoscopic resection, in situ carcinoma of the cervix, or any cured cancer that is considered to have no impact on pfs and os for the current nsclc)
Descripción

Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Excision Endoscopic Gastrointestinal cancer | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasms Cured | Exception Impact Absent Progression-Free Survival | Exception Impact Absent Overall Survival

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0728940
UMLS CUI [3,3]
C0014245
UMLS CUI [3,4]
C0685938
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0006826
UMLS CUI [5,3]
C1880198
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C4049986
UMLS CUI [6,3]
C0332197
UMLS CUI [6,4]
C0242792
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C4049986
UMLS CUI [7,3]
C0332197
UMLS CUI [7,4]
C4086681
national cancer institute common terminology criteria for adverse events (nci ctcae) (version 4.0) grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
Descripción

Toxicity Due to Prior Therapy CTCAE Grades | Toxicity Due to Therapeutic radiology procedure | Exception Alopecia | Improvement Lacking | Toxicity Interferes with Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [1,4]
C1516728
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1522449
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0002170
UMLS CUI [4,1]
C2986411
UMLS CUI [4,2]
C0332268
UMLS CUI [5,1]
C0600688
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0013230
co-administration of anti-cancer therapies other than those administered in this study.
Descripción

Cancer treatment | Exception Study Protocol Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0087111
patients with baseline qtc > 470 ms or symptomatic bradycardia
Descripción

Prolonged QTc | BRADYCARDIA SYMPTOMATIC

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1969409
UMLS CUI [2]
C0741627
receipt of strong/potent cytochrome p4503a inhibitors or inducers within 14 days prior to the first dose until the end of study treatment except for oral corticosteroids up to 20 mg of prednisolone equivalent per day
Descripción

CYP3A Inhibitors Strong | CYP3A Inducers Strong | Exception Adrenal Cortex Hormones Oral U/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3850056
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3850044
UMLS CUI [2,2]
C0442821
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0001617
UMLS CUI [3,3]
C1527415
UMLS CUI [3,4]
C0456683
receipt of any drug with potential qt interval prolonging effects within 14 days prior to the first dose until the end of study treatment
Descripción

Pharmaceutical Preparations Effect Prolonged QT interval

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C0151878
pregnant or breast-feeding women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any clinically significant disease or condition (or history of) that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the principal investigator, pose an unacceptable risk to the patient in this study
Descripción

Disease Interferes with Completion of clinical trial | Condition Interferes with Completion of clinical trial | Disease Interferes with Absorption Oral medication | Condition Interferes with Absorption Oral medication | Disease At risk Patient | Condition At risk Patient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0237442
UMLS CUI [3,4]
C0175795
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0237442
UMLS CUI [4,4]
C0175795
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C1444641
UMLS CUI [5,3]
C0030705
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C1444641
UMLS CUI [6,3]
C0030705
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT02075840

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced ALK Positive TNM clinical staging | Non-small cell lung cancer recurrent ALK Positive TNM clinical staging | Disease Inappropriate Multimodality cancer therapy | Non-small cell lung cancer metastatic ALK Positive TNM clinical staging | ALK Positive Immunohistochemistry
Item
histologically or cytologically confirmed diagnosis of advanced or recurrent (stage iiib not amenable for multimodality treatment) or metastatic (stage iv) nsclc that is alk-positive as assessed by the ventana ihc test
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C4290023 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0278517 (UMLS CUI [2,1])
C4290023 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0920596 (UMLS CUI [3,3])
C0278987 (UMLS CUI [4,1])
C4290023 (UMLS CUI [4,2])
C3258246 (UMLS CUI [4,3])
C4290023 (UMLS CUI [5,1])
C0021044 (UMLS CUI [5,2])
Age
Item
age >/= 18 years old
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog ps of 0-2
boolean
C1520224 (UMLS CUI [1])
Systemic therapy Absent | Non-Small Cell Lung Carcinoma Advanced TNM clinical staging | Non-small cell lung cancer recurrent TNM clinical staging | Disease Inappropriate Multimodality cancer therapy | Non-small cell lung cancer metastatic TNM clinical staging
Item
patients had no prior systemic treatment for advanced or recurrent (stage iiib not amenable for multimodality treatment) or metastatic (stage iv) nsclc
boolean
C1515119 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0278517 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C0920596 (UMLS CUI [4,3])
C0278987 (UMLS CUI [5,1])
C3258246 (UMLS CUI [5,2])
Renal function | Hematologic function | Liver function
Item
adequate renal, hematologic and liver function
boolean
C0232804 (UMLS CUI [1])
C0221130 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Effect Due to Major surgery | Effect Due to Traumatic injury | Patient recovered
Item
patients must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
boolean
C1280500 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0679637 (UMLS CUI [1,3])
C1280500 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C3263723 (UMLS CUI [2,3])
C1115804 (UMLS CUI [3])
Measurable Disease
Item
measurable disease (by recist v1.1) prior to the administration of study treatment
boolean
C1513041 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Asymptomatic | Metastatic Malignant Neoplasm to the Leptomeninges Asymptomatic | Central nervous system lesion Asymptomatic Treated | Neurologic Symptoms CNS metastases | Neurologic Signs CNS metastases | Patient need for Whole brain radiation therapy Complete | Patient need for Gamma knife radiotherapy | Therapeutic radiology procedure Complete | Patient Clinical status Stable
Item
prior brain or leptomeningeal metastases allowed if asymptomatic (e.g., diagnosed incidentally at study baseline). asymptomatic cns lesions might be treated at the discretion of the investigator per local clinical practice. if patients have neurological symptoms or signs due to cns metastasis, patients need to complete whole brain radiation or gamma knife irradiation treatment. in all cases, radiation treatment must be completed at least 14 days before enrollment and patients must be clinically stable
boolean
C0220650 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C1704231 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C0742468 (UMLS CUI [3,1])
C0231221 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C0235031 (UMLS CUI [4,1])
C0686377 (UMLS CUI [4,2])
C0751378 (UMLS CUI [5,1])
C0686377 (UMLS CUI [5,2])
C0686904 (UMLS CUI [6,1])
C1520143 (UMLS CUI [6,2])
C0205197 (UMLS CUI [6,3])
C0686904 (UMLS CUI [7,1])
C2075822 (UMLS CUI [7,2])
C1522449 (UMLS CUI [8,1])
C0205197 (UMLS CUI [8,2])
C0030705 (UMLS CUI [9,1])
C0449440 (UMLS CUI [9,2])
C0205360 (UMLS CUI [9,3])
Use of Contraceptive methods | Contraceptive methods Defined Study Protocol
Item
use of highly effective contraception as defined by the study protocol
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C1704788 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Excision Endoscopic Gastrointestinal cancer | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasms Cured | Exception Impact Absent Progression-Free Survival | Exception Impact Absent Overall Survival
Item
patients with a previous malignancy within the past 3 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal (gi) cancer by endoscopic resection, in situ carcinoma of the cervix, or any cured cancer that is considered to have no impact on pfs and os for the current nsclc)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0728940 (UMLS CUI [3,2])
C0014245 (UMLS CUI [3,3])
C0685938 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C1880198 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C4049986 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
C0242792 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C4049986 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
C4086681 (UMLS CUI [7,4])
Toxicity Due to Prior Therapy CTCAE Grades | Toxicity Due to Therapeutic radiology procedure | Exception Alopecia | Improvement Lacking | Toxicity Interferes with Investigational New Drugs
Item
national cancer institute common terminology criteria for adverse events (nci ctcae) (version 4.0) grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0002170 (UMLS CUI [3,2])
C2986411 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
C0600688 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0013230 (UMLS CUI [5,3])
Cancer treatment | Exception Study Protocol Therapy
Item
co-administration of anti-cancer therapies other than those administered in this study.
boolean
C0920425 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Prolonged QTc | BRADYCARDIA SYMPTOMATIC
Item
patients with baseline qtc > 470 ms or symptomatic bradycardia
boolean
C1969409 (UMLS CUI [1])
C0741627 (UMLS CUI [2])
CYP3A Inhibitors Strong | CYP3A Inducers Strong | Exception Adrenal Cortex Hormones Oral U/day
Item
receipt of strong/potent cytochrome p4503a inhibitors or inducers within 14 days prior to the first dose until the end of study treatment except for oral corticosteroids up to 20 mg of prednisolone equivalent per day
boolean
C3850056 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850044 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
C1527415 (UMLS CUI [3,3])
C0456683 (UMLS CUI [3,4])
Pharmaceutical Preparations Effect Prolonged QT interval
Item
receipt of any drug with potential qt interval prolonging effects within 14 days prior to the first dose until the end of study treatment
boolean
C0013227 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Disease Interferes with Completion of clinical trial | Condition Interferes with Completion of clinical trial | Disease Interferes with Absorption Oral medication | Condition Interferes with Absorption Oral medication | Disease At risk Patient | Condition At risk Patient
Item
any clinically significant disease or condition (or history of) that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the principal investigator, pose an unacceptable risk to the patient in this study
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0237442 (UMLS CUI [3,3])
C0175795 (UMLS CUI [3,4])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0237442 (UMLS CUI [4,3])
C0175795 (UMLS CUI [4,4])
C0012634 (UMLS CUI [5,1])
C1444641 (UMLS CUI [5,2])
C0030705 (UMLS CUI [5,3])
C0348080 (UMLS CUI [6,1])
C1444641 (UMLS CUI [6,2])
C0030705 (UMLS CUI [6,3])
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