ID

40476

Beschreibung

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

Stichworte

Versionen (3)
  1. 17.01.19 17.01.19 -
  2. 20.04.20 20.04.20 -
  3. 25.04.20 25.04.20 -
Rechteinhaber

Novartis Pharmaceuticals

Hochgeladen am

25. April 2020

DOI

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Lizenz

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

Englisch

Eligibility Non-Small Cell Lung Cancer NCT02468661

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
locally advanced or metastatic nsclc
Beschreibung

NSCLC Locally advanced malignant neoplasm | NSCLC Neoplasm metastasis

Datentyp

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)
Beschreibung

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

Datentyp

boolean

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

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

Datentyp

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)
Beschreibung

Resistance Acquired EGFR TKI Generation

Datentyp

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.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

EGFR-TKI Generation Third Prior treatment

Datentyp

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.
Beschreibung

Phase II of clinical trial only

Datentyp

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.
Beschreibung

Phase II of clinical trial only

Datentyp

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
Beschreibung

Phase II of clinical trial only

Datentyp

boolean

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

Eligibility Non-Small Cell Lung Cancer NCT02468661

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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