ID

15695

Description

TIGER-3: Open Label, Multicenter Study of Rociletinib (CO-1686) Mono Therapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR NSCLC Who Have Failed at Least One Previous EGFR-Directed TKI and Platinum-doublet Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT02322281

Link

https://clinicaltrials.gov/show/NCT02322281

Keywords

Versions (1)
  1. 6/8/16 6/8/16 -
Uploaded on

June 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT02322281

English

Eligibility Non-small Cell Lung Cancer NCT02322281

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients must meet all of the following inclusion criteria:
Description

Inclusion criteria All Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0444868
UMLS CUI [1,3]
C1550543
1. histologically or cytologically confirmed metastatic or unresectable locally advanced nsclc with radiological progression on the most recent therapy received
Description

Non-small cell lung cancer metastatic Advanced Locally | Non-Small Cell Lung Carcinoma unresectable Advanced Locally | Therapeutic procedure | Disease Progression Radiologic

Data type

boolean

Alias
UMLS CUI [1,1]
C0278987
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C1519810
UMLS CUI [2,3]
C0205179
UMLS CUI [2,4]
C1517927
UMLS CUI [3]
C0087111
UMLS CUI [4,1]
C0242656
UMLS CUI [4,2]
C0205483
2. documented evidence of a tumor with 1 or more egfr activating mutations excluding exon 20 insertion
Description

Malignant Neoplasms | EGFR Activating Mutation | EGFR gene exon 20 insertion

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C2984891
UMLS CUI [3]
C2733661
3. disease progression confirmed by radiological assessment while receiving treatment with single agent egfr-tki (e.g., erlotinib, gefitinib, afatinib, or dacomitinib).
Description

Disease Progression | Therapeutic procedure | Epidermal Growth Factor Receptor Pharmacologic Substance Single | erlotinib | gefitinib | Afatinib | dacomitinib

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0087111
UMLS CUI [3,1]
C0034802
UMLS CUI [3,2]
C1254351
UMLS CUI [3,3]
C0205171
UMLS CUI [4]
C1135135
UMLS CUI [5]
C1122962
UMLS CUI [6]
C2987648
UMLS CUI [7]
C2987430
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:
Description

Prior Therapy | Disease Progression

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0242656
at least 1 line of prior treatment with a single-agent egfr tki (e.g., erlotinib, gefitinib, afatinib, or dacomitinib)
Description

Prior Therapy | Epidermal Growth Factor Receptor Pharmacologic Substance Single | erlotinib | gefitinib | Afatinib | dacomitinib

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0034802
UMLS CUI [2,2]
C1254351
UMLS CUI [2,3]
C0205171
UMLS CUI [3]
C1135135
UMLS CUI [4]
C1122962
UMLS CUI [5]
C2987648
UMLS CUI [6]
C2987430
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
Description

Therapeutic procedure Epidermal Growth Factor Receptor | Washout Period | Therapeutic procedure rociletinib

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0034802
UMLS CUI [2]
C1710661
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C4045493
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).
Description

Chemotherapy Platinum-Based Double | Disease Progression | treatment and maintenance

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1514162
UMLS CUI [1,3]
C0205173
UMLS CUI [2]
C0242656
UMLS CUI [3]
C0814469
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.
Description

Cytotoxic Chemotherapy | Epidermal Growth Factor Receptor | Chemotherapy Platinum-Based Double

Data type

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C0034802
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1514162
UMLS CUI [3,3]
C0205173
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
Description

Biopsy | Tissue specimen primary tumor | Tissue specimen Metastatic Neoplasm | Tissue specimen Availability

Data type

boolean

Alias
UMLS CUI [1]
C0005558
UMLS CUI [2,1]
C1292533
UMLS CUI [2,2]
C0677930
UMLS CUI [3,1]
C1292533
UMLS CUI [3,2]
C2939420
UMLS CUI [4,1]
C1292533
UMLS CUI [4,2]
C0470187
6. measureable disease according to recist version 1.1
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
7. life expectancy of at least 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
8. ecog performance status of 0 to 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
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)
Description

Age | Age Japan | Age Taiwan | Age Singapore

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C0022341
UMLS CUI [3,1]
C0001779
UMLS CUI [3,2]
C0039260
UMLS CUI [4,1]
C0001779
UMLS CUI [4,2]
C0037173
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
Description

Toxic effect Due to Chemotherapy | Patient recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0392920
UMLS CUI [2]
C1115804
11. adequate hematological and biological function
Description

Hematologic function | Biological function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C3714634
12. written consent on an institutional review board (irb)/independent ethics committee (iec)-approved icf before any study specific evaluation
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any of the following criteria will exclude patients from study participation:
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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
Description

Malignant Neoplasms | mortality High risk | Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0681679
UMLS CUI [2,2]
C0332167
UMLS CUI [3]
C0087111
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
Description

Malignant Neoplasms Treatment completed | Chemotherapy Completed | Bone Marrow Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0580352
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0205197
UMLS CUI [3]
C0005961
2. known pre-existing interstitial lung disease
Description

Lung Diseases, Interstitial Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0206062
UMLS CUI [1,2]
C2347662
3. tumor small cell transformation by local assessment, irrespective of presence of t790m+ component
Description

Small cell carcinoma of lung Cell transformation | EGFR NP_005219.2:p.T790M

Data type

boolean

Alias
UMLS CUI [1,1]
C0149925
UMLS CUI [1,2]
C0040682
UMLS CUI [2]
C3274192
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).
Description

Meningeal Carcinomatosis | CNS metastases | Steroids | Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220654
UMLS CUI [2]
C0686377
UMLS CUI [3]
C0038317
UMLS CUI [4]
C0220650
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)
Description

Therapeutic procedure | Pharmaceutical Preparations Causing Prolonged QT interval

Data type

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0151878
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
Description

Prior Therapy rociletinib | Pharmaceutical Preparations EGFR NP_005219.2:p.T790M | EGFR wt Allele | AZD9291 | EGFR Inhibitor HM61713

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C4045493
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C3274192
UMLS CUI [3]
C1706111
UMLS CUI [4]
C3896906
UMLS CUI [5]
C3640220
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
Description

Medical contraindication Therapeutic procedure pemetrexed | Medical contraindication Therapeutic procedure Paclitaxel | Medical contraindication Therapeutic procedure gemcitabine | Medical contraindication Therapeutic procedure docetaxel | rociletinib

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0210657
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0144576
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0045093
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0246415
UMLS CUI [5]
C4045493
8. any of the following cardiac abnormalities or history:
Description

Congenital Heart Defects

Data type

boolean

Alias
UMLS CUI [1]
C0018798
1. clinically significant abnormal 12-lead ecg, qt interval corrected using fridericia's method (qtcf) > 450 msec
Description

12 lead ECG Abnormal | QTcF - Fridericia's Correction Formula

Data type

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C1882513
2. inability to measure qt interval on ecg
Description

QT interval Measurement Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0429028
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C1299582
3. personal or family history of long qt syndrome
Description

Long QT Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0023976
4. implantable pacemaker or implantable cardioverter defibrillator
Description

Pacemakers, Cardiac, Implantable | Implantable defibrillator

Data type

boolean

Alias
UMLS CUI [1]
C0182148
UMLS CUI [2]
C0162589
5. resting bradycardia < 55 beats/min
Description

Bradycardia, relative resting

Data type

boolean

Alias
UMLS CUI [1]
C3278174
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
Description

Operative Surgical Procedures Other | Patient recovered | Stable status

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C1115804
UMLS CUI [3]
C0205360
10. females who are pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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)
Description

Patients Fertile | Contraceptive methods Refused | Therapeutic procedure | rociletinib | Chemotherapy | Cytotoxic agent

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0015895
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C1705116
UMLS CUI [3]
C0087111
UMLS CUI [4]
C4045493
UMLS CUI [5]
C0392920
UMLS CUI [6]
C0304497
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)
Description

Comorbidity Affecting Study Protocol | Substance Use Disorders | Significant Intercurrent Illness Uncontrolled | DIABETES MELLITUS NOS UNCONTROLLED | Communicable Diseases | Arterial thrombosis | Pulmonary Embolism Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2348563
UMLS CUI [2]
C0038586
UMLS CUI [3,1]
C3640977
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0743131
UMLS CUI [5]
C0009450
UMLS CUI [6]
C0151942
UMLS CUI [7,1]
C0034065
UMLS CUI [7,2]
C0231220
13. any other reason the investigator considers the patient should not participate in the study
Description

Study Subject Participation Status Limited | Judgment clinical research investigator

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0439801
UMLS CUI [2,1]
C0022423
UMLS CUI [2,2]
C1552025
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Similar models

Eligibility Non-small Cell Lung Cancer NCT02322281

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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