Non-Small Cell Lung Carcinoma | No indication of multimodality cancer therapy | Non-Small Cell Lung Carcinoma ALK gene rearrangement positive
Item
1. histologically or cytologically confirmed diagnosis of stage iiib (and is not a candidate for definitive multimodality therapy) or iv alk-positive nsclc.
boolean
C0007131 (UMLS CUI [1])
C0521090 (UMLS CUI [2,1])
C0920596 (UMLS CUI [2,2])
C0007131 (UMLS CUI [3,1])
C3888914 (UMLS CUI [3,2])
Tumor tissue sample Availability | Non-Small Cell Lung Carcinoma | Biopsy New
Item
2. all patients must have a tumor tissue sample available as an archival sample (collected either at the time of diagnosis of nsclc or any time since) or as a new biopsy to send to the novartis designated central laboratory.
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2])
C0005558 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])
Prior Therapy crizotinib | anaplastic lymphoma kinase inhibitors
Item
3. patients may have received one prior treatment regimen with crizotinib (all other alk inhibitors are excluded).
boolean
C1514463 (UMLS CUI [1,1])
C2974289 (UMLS CUI [1,2])
C0252409 (UMLS CUI [2,1])
C0243077 (UMLS CUI [2,2])
Prior Chemotherapy | Biological Response Modifier Therapy | Investigational New Drugs | anaplastic lymphoma kinase inhibitors | crizotinib
Item
4. patients may have received prior chemotherapy, biologic therapy, or other investigational agents. alk inhibitors other than crizotinib are excluded.
boolean
C1514457 (UMLS CUI [1])
C0005527 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C0252409 (UMLS CUI [4,1])
C0243077 (UMLS CUI [4,2])
C2974289 (UMLS CUI [5])
WHO performance status scale
Item
5. patient has a world health organization (who) performance status 0-2.
boolean
C1298650 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion:
boolean
C0680251 (UMLS CUI [1])
Prior Therapy anaplastic lymphoma kinase inhibitors | crizotinib
Item
1. prior treatment with an alk inhibitor other than crizotinib.
boolean
C1514463 (UMLS CUI [1,1])
C0252409 (UMLS CUI [1,2])
C0243077 (UMLS CUI [1,3])
C2974289 (UMLS CUI [2])
Meningeal Carcinomatosis
Item
2. history of carcinomatous meningitis.
boolean
C0220654 (UMLS CUI [1])
Malignant Neoplasms | Malignant Neoplasms ALK gene rearrangement positive Advanced | Therapeutic procedure
Item
3. presence or history of a malignant disease other than an alk-positive advanced tumor that has been diagnosed and/or required therapy within the past 3 years.
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C3888914 (UMLS CUI [2,2])
C0205179 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3])
Heart Diseases Uncontrolled | cardiac event Recent | Lung Diseases, Interstitial | Pneumonia, Interstitial | Radiation Pneumonitis | Activities of Daily Living Affecting | Therapeutic procedure
Item
5. clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months) 6. patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0741923 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0206062 (UMLS CUI [3])
C0206061 (UMLS CUI [4])
C0206063 (UMLS CUI [5])
C0001288 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C0087111 (UMLS CUI [7])
medical condition Severe | medical condition acute | medical condition chronic | Therapeutic procedure Warfarin Sodium | Therapeutic procedure Coumadin | coumarin
Item
7. patient has other severe, acute, or chronic medical conditions 8. patient is currently receiving treatment with warfarin sodium (coumadin®) or any other coumarin-derivative anticoagulants.
boolean
C1699700 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1699700 (UMLS CUI [2,1])
C0205178 (UMLS CUI [2,2])
C1699700 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C0376218 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C0699129 (UMLS CUI [5,2])
C0010206 (UMLS CUI [6])