Age
Item
1. must be greater or equal to 20 years of age
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma
Item
2. must have cytologically or histologically confirmed nsclc with either:
boolean
C0007131 (UMLS CUI [1])
Neoplasm Metastasis TNM clinical staging
Item
metastatic disease (stage iv) or
boolean
C0027627 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Disease TNM clinical staging | Disease Inappropriate Operative Surgical Procedure | Disease Inappropriate Curative - procedure intent
Item
stage iiib disease not amenable to surgery or curative intent.
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C1276305 (UMLS CUI [3,3])
TNM clinical staging
Item
note: it is permissible to use either ajcc version 6.0 or the ajcc version 7.0 staging system. for sites that use ajcc version 7.0, t4m0 patients with other ipsilateral nodules and n0-n2 are still eligible.
boolean
C3258246 (UMLS CUI [1])
Adenocarcinoma | EGFR gene Wild Type | EGFR exon 19 deletion | EGFR Exon 21 Mutation
Item
3. if tumor histology is adenocarcinoma, must have wild-type egfr genotype as assessed by a validated assay that includes exon 19 deletion and exon 21 (l858r) substitution.
boolean
C0001418 (UMLS CUI [1])
C1414313 (UMLS CUI [2,1])
C1883559 (UMLS CUI [2,2])
C3889117 (UMLS CUI [3])
C4289654 (UMLS CUI [4])
Systemic Chemotherapy Quantity Advanced disease | Systemic Chemotherapy Quantity Neoplasm Metastasis | Platinum Doublet
Item
4. must have received one or two prior lines of systemic chemotherapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy.
boolean
C1883256 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
C1883256 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C5206469 (UMLS CUI [3])
Disease Progression | Disease recurrence | Status post Chemotherapy | Status post Chemoradiotherapy
Item
5. must have disease progression or recurrence documented by radiographic assessment following treatment after last chemotherapy or chemoradiation regimen (completed within the previous 12 months).
boolean
C0242656 (UMLS CUI [1])
C0679254 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0436307 (UMLS CUI [4,2])
Availability of Tumor tissue sample
Item
6. must have available recent (before treatment start) or archival tumor specimen.
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
Measurable Disease | Non-Measurable Lesion
Item
7. must have measurable disease for part a, measurable disease or non-measurable disease for part b
boolean
C1513041 (UMLS CUI [1])
C1334988 (UMLS CUI [2])
ECOG performance status
Item
8. must have eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Hematologic function
Item
9. must have adequate hematological function
boolean
C0221130 (UMLS CUI [1])
Renal function
Item
10. must have adequate renal function
boolean
C0232804 (UMLS CUI [1])
Liver function
Item
11. must have adequate hepatic function
boolean
C0232741 (UMLS CUI [1])
Agreement Contraceptive methods
Item
12. agreement to use effective contraception while on treatment and for at least 6 months after end of treatment
boolean
C0680240 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
13. must have provided informed consent for study participation.
boolean
C0021430 (UMLS CUI [1])
Adenocarcinoma of lung | ALK Gene Rearrangement
Item
1. lung adenocarcinoma with an anaplastic lymphoma kinase (alk) gene rearrangement
boolean
C0152013 (UMLS CUI [1])
C4068350 (UMLS CUI [2])
Left ventricular ejection fraction
Item
2. left ventricular ejection fraction (lvef) less than 45%
boolean
C0428772 (UMLS CUI [1])
EGFR targeted therapy | Targeted Therapy HER2 | Targeted Therapy HER3 | Targeted Therapy HER4
Item
3. prior egfr-targeted regimen, anti-her2, anti-her3, or anti-her4 therapy
boolean
C4733187 (UMLS CUI [1])
C2985566 (UMLS CUI [2,1])
C0069515 (UMLS CUI [2,2])
C2985566 (UMLS CUI [3,1])
C0812265 (UMLS CUI [3,2])
C2985566 (UMLS CUI [4,1])
C0812267 (UMLS CUI [4,2])
Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Curative treatment Disease In situ | Exception Curative treatment Solid Neoplasm | Exception Disease Free Duration
Item
4. history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for greater or equal to 5 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0012634 (UMLS CUI [3,3])
C0444498 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0280100 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
Corneal Disease
Item
5. history of corneal disease
boolean
C0010034 (UMLS CUI [1])
Lung Disease, Interstitial
Item
6. history of interstitial lung disease (ild)
boolean
C0206062 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
7. clinically active brain metastases
boolean
C0220650 (UMLS CUI [1])
Uncontrolled hypertension
Item
8. uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
ECG changes Clinical Significance
Item
9. clinically significant ecg changes
boolean
C0855329 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Ascites | Pleural effusion | Requirement Intervention chronic
Item
10. clinically significant (in the opinion of the investigator) ascites or pleural effusion requiring chronic medical intervention
boolean
C0003962 (UMLS CUI [1])
C0032227 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C0205191 (UMLS CUI [3,3])
Myocardial Infarction | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia Unstable | Requirement Pharmaceutical Preparations
Item
11. myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or unstable cardiac arrhythmia requiring medication
boolean
C0027051 (UMLS CUI [1])
C0742758 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C1514873 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
Cancer treatment | Antibody Therapy | Retinoid therapy of cancer | Hormone Therapy
Item
12. treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 4 weeks before study drug treatment
boolean
C0920425 (UMLS CUI [1])
C0281176 (UMLS CUI [2])
C0598926 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
Therapeutic radiology procedure | Major surgery | Palliative course of radiotherapy
Item
13. therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment; or palliative radiation within 2 weeks before study drug treatment
boolean
C1522449 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
C0475092 (UMLS CUI [3])
Study Subject Participation Status | Clinical Trial | Investigational New Drugs
Item
14. participation in clinical drug trials within 4 weeks
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Communicable Disease Uncontrolled | Requirement Antibiotics Intravenous | Requirement Antiviral Agents | Requirement Antifungal Agents | HIV Infection | Hepatitis B | Hepatitis C
Item
15. uncontrolled infection requiring iv antibiotics, antivirals, or antifungals, known human immunodeficiency virus (hiv) infection, or active hepatitis b or c infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0003232 (UMLS CUI [2,2])
C1522726 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0003451 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0003308 (UMLS CUI [4,2])
C0019693 (UMLS CUI [5])
C0019163 (UMLS CUI [6])
C0019196 (UMLS CUI [7])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient
Item
16. history of hypersensitivity to any of the study drugs or to any excipients.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])