ID

31141

Description

A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Having Received Tarceva Monotherapy.; ODM derived from: https://clinicaltrials.gov/show/NCT00773383

Lien

https://clinicaltrials.gov/show/NCT00773383

Mots-clés

Versions (1)
  1. 23/07/2018 23/07/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

23 juillet 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

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Eligibility Non-Small Cell Lung Cancer NCT00773383

Anglais

Eligibility Non-Small Cell Lung Cancer NCT00773383

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients >=18 years with histologically documented inoperable, locally advanced or metastatic (stage iiib or iv) nsclc;
Description

Age | Non-Small Cell Lung Carcinoma Inoperable TNM clinical staging | Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205187
UMLS CUI [2,3]
C3258246
UMLS CUI [3,1]
C0007131
UMLS CUI [3,2]
C0205179
UMLS CUI [3,3]
C1517927
UMLS CUI [3,4]
C3258246
UMLS CUI [4,1]
C0278987
UMLS CUI [4,2]
C3258246
currently receiving tarceva monotherapy and having failed at least one standard chemotherapy regimens;
Description

Tarceva | Standard Chemotherapy Quantity failed

Type de données

boolean

Alias
UMLS CUI [1]
C1135136
UMLS CUI [2,1]
C1442989
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0231175
prior response or stable disease 12 weeks from start of tarceva;
Description

Tarceva | Response Previous | Stable Disease Previous

Type de données

boolean

Alias
UMLS CUI [1]
C1135136
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C0677946
UMLS CUI [3,2]
C0205156
documented progressive disease at enrollment;
Description

Progressive Disease

Type de données

boolean

Alias
UMLS CUI [1]
C1335499
measurable disease according to the recist criteria;
Description

Measurable Disease

Type de données

boolean

Alias
UMLS CUI [1]
C1513041
ecog performance status 0-2;
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy >12 weeks.
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with active cns lesions;
Description

Central nervous system lesion

Type de données

boolean

Alias
UMLS CUI [1]
C0742468
prior treatment with agents acting via igf-1r inhibition or egfr targeting;
Description

IGF-1R inhibitors | EGFR Targeted Therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C4044495
UMLS CUI [1,2]
C0243077
UMLS CUI [2,1]
C0034802
UMLS CUI [2,2]
C2985566
administration with high doses of systemic corticosteroids;
Description

CORTICOSTEROIDS FOR SYSTEMIC USE High dose

Type de données

boolean

Alias
UMLS CUI [1,1]
C3653708
UMLS CUI [1,2]
C0444956
radiotherapy in the 4 weeks prior to study start;
Description

Therapeutic radiology procedure

Type de données

boolean

Alias
UMLS CUI [1]
C1522449
surgery or significant traumatic injury with in the last 2 weeks prior to study start.
Description

Operative Surgical Procedures | Traumatic injury

Type de données

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C3263723
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00773383

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age | Non-Small Cell Lung Carcinoma Inoperable TNM clinical staging | Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging
Item
male or female patients >=18 years with histologically documented inoperable, locally advanced or metastatic (stage iiib or iv) nsclc;
boolean
C0001779 (UMLS CUI [1])
C0007131 (UMLS CUI [2,1])
C0205187 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0007131 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C1517927 (UMLS CUI [3,3])
C3258246 (UMLS CUI [3,4])
C0278987 (UMLS CUI [4,1])
C3258246 (UMLS CUI [4,2])
Tarceva | Standard Chemotherapy Quantity failed
Item
currently receiving tarceva monotherapy and having failed at least one standard chemotherapy regimens;
boolean
C1135136 (UMLS CUI [1])
C1442989 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0231175 (UMLS CUI [2,4])
Tarceva | Response Previous | Stable Disease Previous
Item
prior response or stable disease 12 weeks from start of tarceva;
boolean
C1135136 (UMLS CUI [1])
C1704632 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0677946 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
Progressive Disease
Item
documented progressive disease at enrollment;
boolean
C1335499 (UMLS CUI [1])
Measurable Disease
Item
measurable disease according to the recist criteria;
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2;
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy >12 weeks.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Central nervous system lesion
Item
patients with active cns lesions;
boolean
C0742468 (UMLS CUI [1])
IGF-1R inhibitors | EGFR Targeted Therapy
Item
prior treatment with agents acting via igf-1r inhibition or egfr targeting;
boolean
C4044495 (UMLS CUI [1,1])
C0243077 (UMLS CUI [1,2])
C0034802 (UMLS CUI [2,1])
C2985566 (UMLS CUI [2,2])
CORTICOSTEROIDS FOR SYSTEMIC USE High dose
Item
administration with high doses of systemic corticosteroids;
boolean
C3653708 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
Therapeutic radiology procedure
Item
radiotherapy in the 4 weeks prior to study start;
boolean
C1522449 (UMLS CUI [1])
Operative Surgical Procedures | Traumatic injury
Item
surgery or significant traumatic injury with in the last 2 weeks prior to study start.
boolean
C0543467 (UMLS CUI [1])
C3263723 (UMLS CUI [2])
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