Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | EGFR gene mutation EGFR exon 19 deletion | EGFR gene mutation EGFR NP_005219.2:p.L858R | Therapeutic procedure | Disease Progression
Item
evidence of histologically or cytologically confirmed diagnosis of locally advanced or metastatic egfrm (del19 or l858r) nsclc that has progressed after at least 1 prior line of therapy.
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0278987 (UMLS CUI [2])
C3266992 (UMLS CUI [3,1])
C3889117 (UMLS CUI [3,2])
C3266992 (UMLS CUI [4,1])
C3274204 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5])
C0242656 (UMLS CUI [6])
Therapeutic procedure Epidermal Growth Factor Receptor | Disease Progression
Item
patients must have had disease progression on treatment with an approved egfr tki.
boolean
C0087111 (UMLS CUI [1,1])
C0034802 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
Phase I | Therapeutic procedure Other | Epidermal Growth Factor Receptor
Item
in phase 1, patients may have also received other lines of therapy before or after the egfr tki.
boolean
C0282459 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0034802 (UMLS CUI [3])
Phase 2 | Therapeutic procedure Numerous | Epidermal Growth Factor Receptor
Item
in phase 2, while patients may have had multiple lines of therapy, the last therapy prior to study treatment must have been an approved egfr tki and received within 6 weeks prior to study registration.
boolean
C0282460 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
C0034802 (UMLS CUI [3])
Phase I Part
Item
in the phase 1 portion:
boolean
C0282459 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
Dose Escalation | Maximum Tolerated Dose Increase | EGFR NP_005219.2:p.T790M Positive | EGFR NP_005219.2:p.T790M Unknown
Item
in the dose escalation and mtd expansion portions patients must be t790m positive or unknown status.
boolean
C3816728 (UMLS CUI [1])
C0752079 (UMLS CUI [2,1])
C0442805 (UMLS CUI [2,2])
C3274192 (UMLS CUI [3,1])
C1446409 (UMLS CUI [3,2])
C3274192 (UMLS CUI [4,1])
C0439673 (UMLS CUI [4,2])
Pharmacokinetic study | EGFR gene mutation EGFR exon 19 deletion | EGFR gene mutation EGFR NP_005219.2:p.L858R | EGFR NP_005219.2:p.T790M Any status
Item
in the pk sub-studies, patients with egfrm (del 19 or l858r) with any t790m status are eligible to enroll.
boolean
C0201734 (UMLS CUI [1])
C3266992 (UMLS CUI [2,1])
C3889117 (UMLS CUI [2,2])
C3266992 (UMLS CUI [3,1])
C3274204 (UMLS CUI [3,2])
C3274192 (UMLS CUI [4,1])
C1549503 (UMLS CUI [4,2])
Phase 2 Part
Item
in the phase 2 portion:
boolean
C0282460 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma | EGFR gene mutation EGFR exon 19 deletion EGFR NP_005219.2:p.T790M | EGFR gene mutation EGFR NP_005219.2:p.L858R EGFR NP_005219.2:p.T790M
Item
• patients must have egfrm (del 19 and t790m or l858r and t790m) nsclc tumors
boolean
C0007131 (UMLS CUI [1])
C3266992 (UMLS CUI [2,1])
C3889117 (UMLS CUI [2,2])
C3274192 (UMLS CUI [2,3])
C3266992 (UMLS CUI [3,1])
C3274204 (UMLS CUI [3,2])
C3274192 (UMLS CUI [3,3])
Measurable Disease
Item
patients must have at least one measurable lesion as defined by recist version 1.1
boolean
C1513041 (UMLS CUI [1])
Tumor tissue sample Availability | Formalin-fixed paraffin-embedded tissue specimen | Unstained Specimen
Item
tumor tissue available (ie, formalin fixed paraffin embedded (ffpe) block or 10 unstained sections (5 micron). an archival specimen is acceptable for phase 1; a de novo specimen is required for phase 2.
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C2711483 (UMLS CUI [2])
C1883469 (UMLS CUI [3])
Bone Marrow physiological aspects | Liver function | Renal function
Item
patients must have adequate bone marrow, hepatic and renal functions
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Serum pregnancy test negative
Item
negative serum pregnancy test
boolean
C0430061 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion criteria (partial list)
boolean
C0680251 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Therapeutic radiology procedure | Operative Surgical Procedures | Steroid therapy Discontinued | Neurologic Stable status
Item
previously diagnosed brain metastases, unless the patient has completed their treatment and has recovered from the acute effects of radiation therapy or surgery prior to study registration, have discontinued corticosteroid treatment for these metastases for at least 2 weeks, and are neurologically stable.
boolean
C0220650 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C0149783 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C0205494 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
major surgery
Item
major surgery within 4 weeks prior to registration
boolean
C0679637 (UMLS CUI [1])
Therapeutic radiology procedure
Item
radiation therapy within 2 weeks prior to registration.
boolean
C1522449 (UMLS CUI [1])
cancer treatment Systemic | Epidermal Growth Factor Receptor
Item
systemic anti cancer therapy within 2 weeks or 5 half-lives (whichever is longer) of registration excluding egfr tkis. patients on egfr tkis must discontinue the agent for a minimum of 5 half-lives, or 5 days, whichever is longer, prior to registration
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0034802 (UMLS CUI [2])
P-glycoprotein Inhibitor | dronedarone | Erythromycin | Indinavir | Indinavir+Ritonavir | Itraconazole | Ketoconazole | lapatinib | lopinavir / Ritonavir | Quinidine | Rifampin | Ritonavir | valspodar | Verapamil | vorapaxar | EGFR NP_005219.2:p.T790M Pharmacologic Substance
Item
concurrent use of drugs that are strong p-glycoprotein (p-gp) inhibitors (such as but not limited to: dronedarone, erythromycin, indinavir, indinavir/ritonavir, itraconazole, ketoconazole, lapatinib, lopinavir/ritonavir, quinidine, rifampin, ritonavir, valspodar, verapamil, vorapaxar). patients must avoid the use of drugs that are known strong p-gp inhibitors for the duration of the study. therapy with a t790m directed agent
boolean
C3898062 (UMLS CUI [1])
C0766326 (UMLS CUI [2])
C0014806 (UMLS CUI [3])
C0376637 (UMLS CUI [4])
C1977393 (UMLS CUI [5])
C0064113 (UMLS CUI [6])
C0022625 (UMLS CUI [7])
C1506770 (UMLS CUI [8])
C0939237 (UMLS CUI [9])
C0034414 (UMLS CUI [10])
C0035608 (UMLS CUI [11])
C0292818 (UMLS CUI [12])
C0753474 (UMLS CUI [13])
C0042523 (UMLS CUI [14])
C2974521 (UMLS CUI [15])
C3274192 (UMLS CUI [16,1])
C1254351 (UMLS CUI [16,2])
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