ID

40476

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 25, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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]
C0013203
UMLS CUI [1,2]
C1443775
UMLS CUI [1,3]
C0439661
UMLS CUI [1,4]
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: crizotinib, or any other cmet inhibitor or hgf-targeting inhibitor.
Description

Phase II of clinical trial only

Data type

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.
Description

Phase II of clinical trial only

Data type

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
Description

Phase II of clinical trial only

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1708063
UMLS CUI [1,3]
C0392920
UMLS CUI [1,4]
C1514162
Back to the top of the page

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
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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