ID

40476

Descrição

A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification; ODM derived from: https://clinicaltrials.gov/show/NCT02468661

Link

https://clinicaltrials.gov/show/NCT02468661

Palavras-chave

  1. 17/01/2019 17/01/2019 -
  2. 20/04/2020 20/04/2020 -
  3. 25/04/2020 25/04/2020 -
Titular dos direitos

Novartis Pharmaceuticals

Transferido a

25 de abril de 2020

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 4.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Non-Small Cell Lung Cancer NCT02468661

Eligibility Non-Small Cell Lung Cancer NCT02468661

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
locally advanced or metastatic nsclc
Descrição

NSCLC Locally advanced malignant neoplasm | NSCLC Neoplasm metastasis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0677984
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0027627
egfr mutation (l858r and /or ex19del)
Descrição

EGFR mutation | EGFR Exon 19 Deletion Mutation | EGFR L858R mutation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3266992
UMLS CUI [2]
C3274204
UMLS CUI [3]
C4289657
cmet amplification by fish (gcn ≥ 6),
Descrição

C-MET gene amplification FISH | c-met gene Copy number

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1711106
UMLS CUI [1,2]
C0162789
UMLS CUI [2,1]
C0072453
UMLS CUI [2,2]
C1707513
acquired resistance to egfr tki (1st or 2nd génération)
Descrição

Resistance Acquired EGFR TKI Generation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013203
UMLS CUI [1,2]
C1443775
UMLS CUI [1,3]
C0439661
UMLS CUI [1,4]
C0079411
ecog performance status (ps) ≤ 1.
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with 3rd generation tki
Descrição

EGFR-TKI Generation Third Prior treatment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1443775
UMLS CUI [1,2]
C0079411
UMLS CUI [1,3]
C0205437
UMLS CUI [1,4]
C1514463
phaseii : prior treatment with any of the following agents: crizotinib, or any other cmet inhibitor or hgf-targeting inhibitor.
Descrição

Phase II of clinical trial only

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2974289
UMLS CUI [1,2]
C1514463
UMLS CUI [2,1]
C1999216
UMLS CUI [2,2]
C0072453
UMLS CUI [2,3]
C1514463
UMLS CUI [3,1]
C1999216
UMLS CUI [3,2]
C0062534
UMLS CUI [3,3]
C2985566
UMLS CUI [3,4]
C1514463
phaseii : prior treatment with any of the following agents: concomitant egfr tki and platinum based chemotherapy as first line regimen.
Descrição

Phase II of clinical trial only

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C1443775
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C1707479
UMLS CUI [2,2]
C1514162
UMLS CUI [2,3]
C0392920
UMLS CUI [2,4]
C1514463
UMLS CUI [3]
C1708063
phaseii : prior treatment with any of the following agents: platinum-based chemotherapy as first line treatment
Descrição

Phase II of clinical trial only

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1708063
UMLS CUI [1,3]
C0392920
UMLS CUI [1,4]
C1514162

Similar models

Eligibility Non-Small Cell Lung Cancer NCT02468661

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
NSCLC Locally advanced malignant neoplasm | NSCLC Neoplasm metastasis
Item
locally advanced or metastatic nsclc
boolean
C0007131 (UMLS CUI [1,1])
C0677984 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
EGFR mutation | EGFR Exon 19 Deletion Mutation | EGFR L858R mutation
Item
egfr mutation (l858r and /or ex19del)
boolean
C3266992 (UMLS CUI [1])
C3274204 (UMLS CUI [2])
C4289657 (UMLS CUI [3])
C-MET gene amplification FISH | c-met gene Copy number
Item
cmet amplification by fish (gcn ≥ 6),
boolean
C1711106 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C0072453 (UMLS CUI [2,1])
C1707513 (UMLS CUI [2,2])
Resistance Acquired EGFR TKI Generation
Item
acquired resistance to egfr tki (1st or 2nd génération)
boolean
C0013203 (UMLS CUI [1,1])
C1443775 (UMLS CUI [1,2])
C0439661 (UMLS CUI [1,3])
C0079411 (UMLS CUI [1,4])
ECOG performance status
Item
ecog performance status (ps) ≤ 1.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
EGFR-TKI Generation Third Prior treatment
Item
prior treatment with 3rd generation tki
boolean
C1443775 (UMLS CUI [1,1])
C0079411 (UMLS CUI [1,2])
C0205437 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,4])
Prior therapy with crizotinib, c-met inhibitors, HGF-targeting inhibitors
Item
phaseii : prior treatment with any of the following agents: crizotinib, or any other cmet inhibitor or hgf-targeting inhibitor.
boolean
C2974289 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C1999216 (UMLS CUI [2,1])
C0072453 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
C1999216 (UMLS CUI [3,1])
C0062534 (UMLS CUI [3,2])
C2985566 (UMLS CUI [3,3])
C1514463 (UMLS CUI [3,4])
Prior concomitant therapy with EGFR-TKI and Platinum-based Chemotherapy | First line treatment
Item
phaseii : prior treatment with any of the following agents: concomitant egfr tki and platinum based chemotherapy as first line regimen.
boolean
C1707479 (UMLS CUI [1,1])
C1443775 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1707479 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C1514463 (UMLS CUI [2,4])
C1708063 (UMLS CUI [3])
Prior first line Platinum-Based Chemotherapy
Item
phaseii : prior treatment with any of the following agents: platinum-based chemotherapy as first line treatment
boolean
C1514463 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C1514162 (UMLS CUI [1,4])

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial