ID

40434

Description

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

Keywords

Versions (3)
  1. 1/17/19 1/17/19 -
  2. 4/20/20 4/20/20 -
  3. 4/25/20 4/25/20 -
Copyright Holder

Novartis Pharmaceuticals

Uploaded on

April 20, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Non-Small Cell Lung Cancer NCT02468661

English

Eligibility Non-Small Cell Lung Cancer NCT02468661

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
locally advanced or metastatic nsclc
Description

NSCLC Locally advanced malignant neoplasm | NSCLC Neoplasm metastasis

Data type

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)
Description

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

Data type

boolean

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

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

Data type

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)
Description

Resistance Acquired EGFR TKI Generation

Data type

boolean

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

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

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

EGFR-TKI Generation Third Prior treatment

Data type

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:
Description

Phase II clinical trials | Prior treatment with following agents

Data type

boolean

Alias
UMLS CUI [1]
C0282460
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1514463
UMLS CUI [2,3]
C0332282
crizotinib, or any other cmet inhibitor or hgf-targeting inhibitor.
Description

Crizotinib | Inhibitor c-met | Inhibitor HGF targeted therapy

Data type

boolean

Alias
UMLS CUI [1]
C2974289
UMLS CUI [2,1]
C1999216
UMLS CUI [2,2]
C0072453
UMLS CUI [3,1]
C1999216
UMLS CUI [3,2]
C0062534
UMLS CUI [3,3]
C2985566
concomitant egfr tki and platinum based chemotherapy as first line regimen.
Description

Concomitant therapy EGFR-TKI | Concomitant therapy Platinum-based Chemotherapy regimen | First line treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C1443775
UMLS CUI [2,1]
C1707479
UMLS CUI [2,2]
C1514162
UMLS CUI [2,3]
C0392920
UMLS CUI [3]
C1708063
platinum-based chemotherapy as first line treatment
Description

First line Chemotherapy Platinum-Based

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1514162
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT02468661

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
C1443775 (UMLS CUI [1,1])
C0439661 (UMLS CUI [1,2])
C0079411 (UMLS CUI [1,3])
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])
Phase II clinical trials | Prior treatment with following agents
Item
phaseii : prior treatment with any of the following agents:
boolean
C0282460 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C0332282 (UMLS CUI [2,3])
Crizotinib | Inhibitor c-met | Inhibitor HGF targeted therapy
Item
crizotinib, or any other cmet inhibitor or hgf-targeting inhibitor.
boolean
C2974289 (UMLS CUI [1])
C1999216 (UMLS CUI [2,1])
C0072453 (UMLS CUI [2,2])
C1999216 (UMLS CUI [3,1])
C0062534 (UMLS CUI [3,2])
C2985566 (UMLS CUI [3,3])
Concomitant therapy EGFR-TKI | Concomitant therapy Platinum-based Chemotherapy regimen | First line treatment
Item
concomitant egfr tki and platinum based chemotherapy as first line regimen.
boolean
C1707479 (UMLS CUI [1,1])
C1443775 (UMLS CUI [1,2])
C1707479 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C1708063 (UMLS CUI [3])
First line Chemotherapy Platinum-Based
Item
platinum-based chemotherapy as first line treatment
boolean
C1708063 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1514162 (UMLS CUI [1,3])
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