ID

44257

Descripción

A Study of Necitumumab and Abemaciclib in Participants With Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT02411591

Link

https://clinicaltrials.gov/show/NCT02411591

Palabras clave

Versiones (2)
  1. 19/2/19 19/2/19 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT02411591

Inglés

Eligibility Carcinoma, Non-Small-Cell Lung NCT02411591

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed nsclc stage iv:
Descripción

Non-Small Cell Lung Carcinoma TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
part a: nsclc stage iv (any type).
Descripción

Non-Small Cell Lung Carcinoma TNM clinical staging | Type Any

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0332307
UMLS CUI [2,2]
C1552551
part b: nsclc stage iv (squamous and nonsquamous).
Descripción

Squamous non-small cell lung cancer TNM clinical staging | Non-Squamous Non-Small Cell Lung Carcinoma TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4509816
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C4324656
UMLS CUI [2,2]
C3258246
measurable disease at the time of study entry as defined by response evaluation criteria in solid tumors version 1.1 (recist 1.1).
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
the participant must have progressed after platinum-based chemotherapy and have received a maximum of 1 other prior chemotherapy for advanced and/or metastatic disease or must be judged by the physician as ineligible for further standard second-line chemotherapy. prior treatment with epidermal growth factor receptor-tyrosine kinase inhibitor (egfr-tki) and anaplastic lymphoma kinase (alk) inhibitors is mandatory in participants whose tumor has egfr-activating mutations or alk translocations. prior targeting agents and neoadjuvant/adjuvant therapies are permitted with the exception of cyclin-dependent kinase (cdk)4/6-targeting agents or necitumumab.
Descripción

Disease Progression | Status post Chemotherapy Platinum-Based | Prior Chemotherapy Advanced disease | Prior Chemotherapy Neoplasm Metastasis | Ineligibility Second line treatment Chemotherapy | Epidermal growth factor receptor inhibitor | Anaplastic lymphoma kinase inhibitors | EGFR Activating Mutation | ALK Gene Translocation | Targeted Therapy | Neoadjuvant Therapy | Adjuvant therapy | Exception Pharmaceutical Preparations Targeting CDK4 | Exception Pharmaceutical Preparations Targeting CDK6 | Exception Necitumumab

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C1514162
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C0679246
UMLS CUI [4,1]
C1514457
UMLS CUI [4,2]
C0027627
UMLS CUI [5,1]
C1512714
UMLS CUI [5,2]
C1710038
UMLS CUI [5,3]
C0392920
UMLS CUI [6]
C1443775
UMLS CUI [7,1]
C0252409
UMLS CUI [7,2]
C0243077
UMLS CUI [8]
C2984891
UMLS CUI [9]
C4329227
UMLS CUI [10]
C2985566
UMLS CUI [11]
C0600558
UMLS CUI [12]
C0677850
UMLS CUI [13,1]
C1705847
UMLS CUI [13,2]
C0013227
UMLS CUI [13,3]
C1521840
UMLS CUI [13,4]
C0694873
UMLS CUI [14,1]
C1705847
UMLS CUI [14,2]
C0013227
UMLS CUI [14,3]
C1521840
UMLS CUI [14,4]
C1413287
UMLS CUI [15,1]
C1705847
UMLS CUI [15,2]
C2352806
the participant has tumor tissue available for biomarker analyses.
Descripción

Availability of Tumor tissue sample | Biomarker Analysis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [2,1]
C0005516
UMLS CUI [2,2]
C0002778
the participant has an eastern cooperative oncology group performance status score of 0-1.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
have adequate organ functions.
Descripción

Organ function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
the participant is currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device. prior treatment with cdk4/6-targeting agents or necitumumab is not permitted.
Descripción

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Pharmaceutical Preparations Targeting CDK4 | Pharmaceutical Preparations Targeting CDK6 | necitumumab

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C1521840
UMLS CUI [4,3]
C0694873
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C1521840
UMLS CUI [5,3]
C1413287
UMLS CUI [6]
C2352806
have a serious concomitant systemic disorder or significant cardiac disease.
Descripción

Comorbidity Systemic Serious | Heart Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0205404
UMLS CUI [2]
C0018799
the participant has undergone major surgery or received any investigational therapy in the 30-days prior to study enrollment.
Descripción

Major surgery | Therapy, Investigational

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0949266
the participant has undergone chest irradiation within 4 weeks prior to receiving study treatment.
Descripción

Radiotherapy to thorax

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4038705
the participant has brain metastases that are symptomatic.
Descripción

Metastatic malignant neoplasm to brain Symptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
history of arterial or venous thromboembolism within 3 months prior to study enrollment. participants with a history of venous thromboembolism beyond 3 months prior to study enrollment can be enrolled if they are appropriately treated with low molecular weight heparin.
Descripción

Arterial thromboembolism | Venous Thromboembolism

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3544094
UMLS CUI [2]
C1861172
the participant has any ongoing or active infection.
Descripción

Communicable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
the participant has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab or abemaciclib, or any other contraindication to one of the administered treatments.
Descripción

Hypersensitivity Therapeutic procedure Component | Allergic Reaction Therapeutic procedure Component | Hypersensitivity Necitumumab Ingredient | Allergic Reaction Necitumumab Ingredient | Hypersensitivity Abemaciclib Ingredient | Allergic Reaction Abemaciclib Ingredient | Medical contraindication Therapeutic procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C1705248
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2352806
UMLS CUI [3,3]
C1550600
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C2352806
UMLS CUI [4,3]
C1550600
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C3852841
UMLS CUI [5,3]
C1550600
UMLS CUI [6,1]
C1527304
UMLS CUI [6,2]
C3852841
UMLS CUI [6,3]
C1550600
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0087111
the participant is pregnant or breastfeeding.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
the participant has a concurrent active malignancy. previous history of malignancy is permitted, provided that the participant has been free of disease for ≥3 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, preinvasive carcinoma of the cervix, or any cancers that in the judgment of the investigator and sponsor may not affect the interpretation of results (for example, prostate, bladder).
Descripción

Cancer Other | Exception Disease Free Duration | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Prostate carcinoma | Exception Malignant neoplasm of urinary bladder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
UMLS CUI [2,4]
C0449238
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0600139
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0005684
history of interstitial lung disease.
Descripción

Lung Disease, Interstitial

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206062
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT02411591

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histologically or cytologically confirmed nsclc stage iv:
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma TNM clinical staging | Type Any
Item
part a: nsclc stage iv (any type).
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0332307 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
Squamous non-small cell lung cancer TNM clinical staging | Non-Squamous Non-Small Cell Lung Carcinoma TNM clinical staging
Item
part b: nsclc stage iv (squamous and nonsquamous).
boolean
C4509816 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C4324656 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Measurable Disease
Item
measurable disease at the time of study entry as defined by response evaluation criteria in solid tumors version 1.1 (recist 1.1).
boolean
C1513041 (UMLS CUI [1])
Disease Progression | Status post Chemotherapy Platinum-Based | Prior Chemotherapy Advanced disease | Prior Chemotherapy Neoplasm Metastasis | Ineligibility Second line treatment Chemotherapy | Epidermal growth factor receptor inhibitor | Anaplastic lymphoma kinase inhibitors | EGFR Activating Mutation | ALK Gene Translocation | Targeted Therapy | Neoadjuvant Therapy | Adjuvant therapy | Exception Pharmaceutical Preparations Targeting CDK4 | Exception Pharmaceutical Preparations Targeting CDK6 | Exception Necitumumab
Item
the participant must have progressed after platinum-based chemotherapy and have received a maximum of 1 other prior chemotherapy for advanced and/or metastatic disease or must be judged by the physician as ineligible for further standard second-line chemotherapy. prior treatment with epidermal growth factor receptor-tyrosine kinase inhibitor (egfr-tki) and anaplastic lymphoma kinase (alk) inhibitors is mandatory in participants whose tumor has egfr-activating mutations or alk translocations. prior targeting agents and neoadjuvant/adjuvant therapies are permitted with the exception of cyclin-dependent kinase (cdk)4/6-targeting agents or necitumumab.
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C1514162 (UMLS CUI [2,3])
C1514457 (UMLS CUI [3,1])
C0679246 (UMLS CUI [3,2])
C1514457 (UMLS CUI [4,1])
C0027627 (UMLS CUI [4,2])
C1512714 (UMLS CUI [5,1])
C1710038 (UMLS CUI [5,2])
C0392920 (UMLS CUI [5,3])
C1443775 (UMLS CUI [6])
C0252409 (UMLS CUI [7,1])
C0243077 (UMLS CUI [7,2])
C2984891 (UMLS CUI [8])
C4329227 (UMLS CUI [9])
C2985566 (UMLS CUI [10])
C0600558 (UMLS CUI [11])
C0677850 (UMLS CUI [12])
C1705847 (UMLS CUI [13,1])
C0013227 (UMLS CUI [13,2])
C1521840 (UMLS CUI [13,3])
C0694873 (UMLS CUI [13,4])
C1705847 (UMLS CUI [14,1])
C0013227 (UMLS CUI [14,2])
C1521840 (UMLS CUI [14,3])
C1413287 (UMLS CUI [14,4])
C1705847 (UMLS CUI [15,1])
C2352806 (UMLS CUI [15,2])
Availability of Tumor tissue sample | Biomarker Analysis
Item
the participant has tumor tissue available for biomarker analyses.
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0005516 (UMLS CUI [2,1])
C0002778 (UMLS CUI [2,2])
ECOG performance status
Item
the participant has an eastern cooperative oncology group performance status score of 0-1.
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
have adequate organ functions.
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Pharmaceutical Preparations Targeting CDK4 | Pharmaceutical Preparations Targeting CDK6 | necitumumab
Item
the participant is currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device. prior treatment with cdk4/6-targeting agents or necitumumab is not permitted.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C1521840 (UMLS CUI [4,2])
C0694873 (UMLS CUI [4,3])
C0013227 (UMLS CUI [5,1])
C1521840 (UMLS CUI [5,2])
C1413287 (UMLS CUI [5,3])
C2352806 (UMLS CUI [6])
Comorbidity Systemic Serious | Heart Disease
Item
have a serious concomitant systemic disorder or significant cardiac disease.
boolean
C0009488 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0018799 (UMLS CUI [2])
Major surgery | Therapy, Investigational
Item
the participant has undergone major surgery or received any investigational therapy in the 30-days prior to study enrollment.
boolean
C0679637 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Radiotherapy to thorax
Item
the participant has undergone chest irradiation within 4 weeks prior to receiving study treatment.
boolean
C4038705 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Symptomatic
Item
the participant has brain metastases that are symptomatic.
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Arterial thromboembolism | Venous Thromboembolism
Item
history of arterial or venous thromboembolism within 3 months prior to study enrollment. participants with a history of venous thromboembolism beyond 3 months prior to study enrollment can be enrolled if they are appropriately treated with low molecular weight heparin.
boolean
C3544094 (UMLS CUI [1])
C1861172 (UMLS CUI [2])
Communicable Disease
Item
the participant has any ongoing or active infection.
boolean
C0009450 (UMLS CUI [1])
Hypersensitivity Therapeutic procedure Component | Allergic Reaction Therapeutic procedure Component | Hypersensitivity Necitumumab Ingredient | Allergic Reaction Necitumumab Ingredient | Hypersensitivity Abemaciclib Ingredient | Allergic Reaction Abemaciclib Ingredient | Medical contraindication Therapeutic procedure
Item
the participant has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab or abemaciclib, or any other contraindication to one of the administered treatments.
boolean
C0020517 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C1527304 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C2352806 (UMLS CUI [3,2])
C1550600 (UMLS CUI [3,3])
C1527304 (UMLS CUI [4,1])
C2352806 (UMLS CUI [4,2])
C1550600 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C3852841 (UMLS CUI [5,2])
C1550600 (UMLS CUI [5,3])
C1527304 (UMLS CUI [6,1])
C3852841 (UMLS CUI [6,2])
C1550600 (UMLS CUI [6,3])
C1301624 (UMLS CUI [7,1])
C0087111 (UMLS CUI [7,2])
Pregnancy | Breast Feeding
Item
the participant is pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer Other | Exception Disease Free Duration | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Prostate carcinoma | Exception Malignant neoplasm of urinary bladder
Item
the participant has a concurrent active malignancy. previous history of malignancy is permitted, provided that the participant has been free of disease for ≥3 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, preinvasive carcinoma of the cervix, or any cancers that in the judgment of the investigator and sponsor may not affect the interpretation of results (for example, prostate, bladder).
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0600139 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0005684 (UMLS CUI [7,2])
Lung Disease, Interstitial
Item
history of interstitial lung disease.
boolean
C0206062 (UMLS CUI [1])
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