Inclusion criteria All Fulfill
Item
all patients must meet all of the following inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Non-small cell lung cancer metastatic Advanced Locally | Non-Small Cell Lung Carcinoma unresectable Advanced Locally | Therapeutic procedure | Disease Progression Radiologic
Item
1. histologically or cytologically confirmed metastatic or unresectable locally advanced nsclc with radiological progression on the most recent therapy received
boolean
C0278987 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0007131 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C0205179 (UMLS CUI [2,3])
C1517927 (UMLS CUI [2,4])
C0087111 (UMLS CUI [3])
C0242656 (UMLS CUI [4,1])
C0205483 (UMLS CUI [4,2])
Malignant Neoplasms | EGFR Activating Mutation | EGFR gene exon 20 insertion
Item
2. documented evidence of a tumor with 1 or more egfr activating mutations excluding exon 20 insertion
boolean
C0006826 (UMLS CUI [1])
C2984891 (UMLS CUI [2])
C2733661 (UMLS CUI [3])
Disease Progression | Therapeutic procedure | Epidermal Growth Factor Receptor Pharmacologic Substance Single | erlotinib | gefitinib | Afatinib | dacomitinib
Item
3. disease progression confirmed by radiological assessment while receiving treatment with single agent egfr-tki (e.g., erlotinib, gefitinib, afatinib, or dacomitinib).
boolean
C0242656 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0034802 (UMLS CUI [3,1])
C1254351 (UMLS CUI [3,2])
C0205171 (UMLS CUI [3,3])
C1135135 (UMLS CUI [4])
C1122962 (UMLS CUI [5])
C2987648 (UMLS CUI [6])
C2987430 (UMLS CUI [7])
Prior Therapy | Disease Progression
Item
4. multiple lines of prior treatment are permitted and there is no specified order of treatment, but in the course of their treatment history, patients must have received and have radiologically documented disease progression following:
boolean
C1514463 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
Prior Therapy | Epidermal Growth Factor Receptor Pharmacologic Substance Single | erlotinib | gefitinib | Afatinib | dacomitinib
Item
at least 1 line of prior treatment with a single-agent egfr tki (e.g., erlotinib, gefitinib, afatinib, or dacomitinib)
boolean
C1514463 (UMLS CUI [1])
C0034802 (UMLS CUI [2,1])
C1254351 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C1135135 (UMLS CUI [3])
C1122962 (UMLS CUI [4])
C2987648 (UMLS CUI [5])
C2987430 (UMLS CUI [6])
Therapeutic procedure Epidermal Growth Factor Receptor | Washout Period | Therapeutic procedure rociletinib
Item
if egfr-tki is a component of the most recent treatment line, the washout period for the egfr-tki is a minimum of 3 days before the start of rociletinib treatment
boolean
C0087111 (UMLS CUI [1,1])
C0034802 (UMLS CUI [1,2])
C1710661 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C4045493 (UMLS CUI [3,2])
Chemotherapy Platinum-Based Double | Disease Progression | treatment and maintenance
Item
a platinum-containing doublet chemotherapy (either progressed during therapy or completed at least 4 cycles without progression with subsequent progression after a treatment-free interval or after a maintenance treatment).
boolean
C0392920 (UMLS CUI [1,1])
C1514162 (UMLS CUI [1,2])
C0205173 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2])
C0814469 (UMLS CUI [3])
Cytotoxic Chemotherapy | Epidermal Growth Factor Receptor | Chemotherapy Platinum-Based Double
Item
if cytotoxic chemotherapy is a component of the most recent treatment line, treatment with chemotherapy should have been completed at least 14 days prior to start of study treatment. when an egfr-tki is given in combination with platinum-containing doublet chemotherapy, treatment with the egfr-tki may continue until at least 3 days before start of treatment.
boolean
C0677881 (UMLS CUI [1])
C0034802 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C1514162 (UMLS CUI [3,2])
C0205173 (UMLS CUI [3,3])
Biopsy | Tissue specimen primary tumor | Tissue specimen Metastatic Neoplasm | Tissue specimen Availability
Item
5. have undergone a biopsy of either primary or metastatic tumor tissue within 60 days prior to start of treatment and have tissue available to send to sponsor laboratory or are able to undergo a biopsy during screening and provide tissue to sponsor laboratory
boolean
C0005558 (UMLS CUI [1])
C1292533 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
C1292533 (UMLS CUI [3,1])
C2939420 (UMLS CUI [3,2])
C1292533 (UMLS CUI [4,1])
C0470187 (UMLS CUI [4,2])
Measurable Disease
Item
6. measureable disease according to recist version 1.1
boolean
C1513041 (UMLS CUI [1])
Life Expectancy
Item
7. life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
8. ecog performance status of 0 to 1
boolean
C1520224 (UMLS CUI [1])
Age | Age Japan | Age Taiwan | Age Singapore
Item
9. age ≥ 18 years (in certain territories, the minimum age requirement may be higher e.g., age ≥ 20 years in japan and taiwan, age ≥ 21 years in singapore)
boolean
C0001779 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C0022341 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3,1])
C0039260 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4,1])
C0037173 (UMLS CUI [4,2])
Toxic effect Due to Chemotherapy | Patient recovered
Item
10. patients should have recovered to national cancer institute (nci) common terminology criteria for adverse events (ctcae) grade ≤ 1 from any significant chemotherapy-related toxicities
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C1115804 (UMLS CUI [2])
Hematologic function | Biological function
Item
11. adequate hematological and biological function
boolean
C0221130 (UMLS CUI [1])
C3714634 (UMLS CUI [2])
Informed consent
Item
12. written consent on an institutional review board (irb)/independent ethics committee (iec)-approved icf before any study specific evaluation
boolean
C0021430 (UMLS CUI [1])
Study Subject Participation Status
Item
any of the following criteria will exclude patients from study participation:
boolean
C2348568 (UMLS CUI [1])
Malignant Neoplasms | mortality High risk | Therapeutic procedure
Item
1. any other malignancy associated with a high mortality risk within the next 5 years and for which the patients may be (but not necessarily) currently receiving treatment
boolean
C0006826 (UMLS CUI [1])
C0681679 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3])
Malignant Neoplasms Treatment completed | Chemotherapy Completed | Bone Marrow Transplantation
Item
patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enroll in the trial provided all chemotherapy was completed > 6 months prior and/or bone marrow transplant > 2 years prior
boolean
C0006826 (UMLS CUI [1,1])
C0580352 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0005961 (UMLS CUI [3])
Lung Diseases, Interstitial Pre-existing
Item
2. known pre-existing interstitial lung disease
boolean
C0206062 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Small cell carcinoma of lung Cell transformation | EGFR NP_005219.2:p.T790M
Item
3. tumor small cell transformation by local assessment, irrespective of presence of t790m+ component
boolean
C0149925 (UMLS CUI [1,1])
C0040682 (UMLS CUI [1,2])
C3274192 (UMLS CUI [2])
Meningeal Carcinomatosis | CNS metastases | Steroids | Metastatic malignant neoplasm to brain
Item
4. patients with leptomeningeal carcinomatosis are excluded. other central nervous system (cns) metastases are only permitted if treated, asymptomatic, and stable (not requiring steroids for at least 2 weeks prior to randomization and the patient is neurologically stable i.e. free from new symptoms of brain metastases).
boolean
C0220654 (UMLS CUI [1])
C0686377 (UMLS CUI [2])
C0038317 (UMLS CUI [3])
C0220650 (UMLS CUI [4])
Therapeutic procedure | Pharmaceutical Preparations Causing Prolonged QT interval
Item
5. patients who are currently receiving treatment with any medications that have the potential to prolong the qt interval and that treatment cannot be either discontinued or switched to a different medication (known to have no effect on qt) before starting protocol-specified treatment (see http://crediblemeds.org/ for a list of qt-prolonging medications)
boolean
C0087111 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0151878 (UMLS CUI [2,3])
Prior Therapy rociletinib | Pharmaceutical Preparations EGFR NP_005219.2:p.T790M | EGFR wt Allele | AZD9291 | EGFR Inhibitor HM61713
Item
6. prior treatment with rociletinib, or other drugs that target t790m+ mutant egfr with sparing of wt-egfr including but not limited to azd9291, hm61713, and tas-121
boolean
C1514463 (UMLS CUI [1,1])
C4045493 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C3274192 (UMLS CUI [2,2])
C1706111 (UMLS CUI [3])
C3896906 (UMLS CUI [4])
C3640220 (UMLS CUI [5])
Medical contraindication Therapeutic procedure pemetrexed | Medical contraindication Therapeutic procedure Paclitaxel | Medical contraindication Therapeutic procedure gemcitabine | Medical contraindication Therapeutic procedure docetaxel | rociletinib
Item
7. any contraindications for therapy with pemetrexed, paclitaxel, gemcitabine or docetaxel unless a contraindication with respect to one of these drugs will not affect the use of any of the others as a comparator to rociletinib
boolean
C1301624 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0210657 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0144576 (UMLS CUI [2,3])
C1301624 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0045093 (UMLS CUI [3,3])
C1301624 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0246415 (UMLS CUI [4,3])
C4045493 (UMLS CUI [5])
Congenital Heart Defects
Item
8. any of the following cardiac abnormalities or history:
boolean
C0018798 (UMLS CUI [1])
12 lead ECG Abnormal | QTcF - Fridericia's Correction Formula
Item
1. clinically significant abnormal 12-lead ecg, qt interval corrected using fridericia's method (qtcf) > 450 msec
boolean
C0430456 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C1882513 (UMLS CUI [2])
QT interval Measurement Unable
Item
2. inability to measure qt interval on ecg
boolean
C0429028 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Long QT Syndrome
Item
3. personal or family history of long qt syndrome
boolean
C0023976 (UMLS CUI [1])
Pacemakers, Cardiac, Implantable | Implantable defibrillator
Item
4. implantable pacemaker or implantable cardioverter defibrillator
boolean
C0182148 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
Bradycardia, relative resting
Item
5. resting bradycardia < 55 beats/min
boolean
C3278174 (UMLS CUI [1])
Operative Surgical Procedures Other | Patient recovered | Stable status
Item
9. non-study related surgical procedures ≤ 7 days prior to randomization. in all cases, the patient must be sufficiently recovered and stable before treatment administration
boolean
C0543467 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1115804 (UMLS CUI [2])
C0205360 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
10. females who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Patients Fertile | Contraceptive methods Refused | Therapeutic procedure | rociletinib | Chemotherapy | Cytotoxic agent
Item
11. refusal to use adequate contraception for fertile patients (females and males) while on treatment and for 6 months after the last dose of study treatment (rociletinib and chemotherapy irrespective of single cytotoxic agent used)
boolean
C0030705 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3])
C4045493 (UMLS CUI [4])
C0392920 (UMLS CUI [5])
C0304497 (UMLS CUI [6])
Comorbidity Affecting Study Protocol | Substance Use Disorders | Significant Intercurrent Illness Uncontrolled | DIABETES MELLITUS NOS UNCONTROLLED | Communicable Diseases | Arterial thrombosis | Pulmonary Embolism Symptomatic
Item
12. presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including uncontrolled diabetes, active infection, arterial thrombosis, and symptomatic pulmonary embolism)
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0038586 (UMLS CUI [2])
C3640977 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0743131 (UMLS CUI [4])
C0009450 (UMLS CUI [5])
C0151942 (UMLS CUI [6])
C0034065 (UMLS CUI [7,1])
C0231220 (UMLS CUI [7,2])
Study Subject Participation Status Limited | Judgment clinical research investigator
Item
13. any other reason the investigator considers the patient should not participate in the study
boolean
C2348568 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0022423 (UMLS CUI [2,1])
C1552025 (UMLS CUI [2,2])