Osimertinib in Treating Patients With Stage IIIB-IV or Recurrent Non-small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:April 5, 2018
End Date:July 31, 2022

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Phase II Study of AZD9291 (Osimertinib) in Advanced NSCLC Patients With Exon 20 Insertion Mutations in EGFR

This phase II trial studies how well osimertinib works in treating patients with non-small
cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back.
Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for
cell growth.

PRIMARY OBJECTIVES:

I. To evaluate the best objective response rate of AZD9291 (osimertinib) among patients with
EGFR exon 20 insertions.

SECONDARY OBJECTIVES:

I. To determine the safety profile of 160 mg once daily (QD) dose of AZD9291 (osimertinib) in
patients with EGFR Exon 20 insertion mutations.

II. To determine the progression-free survival. III. To determine the overall survival.

TERTIARY OBJECTIVES:

I. To characterize molecular markers of response to treatment in circulating tumor
deoxyribonucleic acid (DNA).

II. To evaluate biomarkers of response to treatment through retrospective analyses of
pre-treatment tumor tissue.

III. To identify resistance mechanisms to AZD9291 (osimertinib) through post-progression
tumor biopsies and circulating tumor (ct)DNA.

OUTLINE:

Patients receive osimertinib orally (PO) once daily (QD) on days 1-21. Courses repeat every
21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 28 days and every 3 months
for up to 5 years.

Inclusion Criteria:

- Participants must have a pathologically-confirmed diagnosis of non-small cell lung
cancer (NSCLC)

- Participants must have advanced disease - either stage IV disease, stage IIIB disease
not amenable to definitive multi-modality therapy, or recurrent disease after a prior
diagnosis of stage I-III disease; all staging is via the American Joint Committee on
Cancer (AJCC)/International Association for the Study of Lung Cancer (IASLC) 7th
edition staging criteria

- An EGFR exon 20 insertion mutation must be detected in the tumor tissue; patients may
be enrolled in the study based on an exon 20 insertion EGFR mutation detected by any
Clinical Laboratory Improvement Act (CLIA)-certified tissue assay

- NOTE: Testing results are to be submitted via Medidata Rave and the study chair
or delegate will review the reports

- Patients must have measurable disease; baseline measurements and ALL sites of disease
must be obtained within 4 weeks to registration

- Patients must have previously received at least one line of therapy for their advanced
lung cancer; there are no restrictions on the maximum number of prior therapies
allowed

- Participants may not have received any prior treatment with therapies targeting PDL1,
PD1 or CTLA4

- Eastern Cooperative Oncology Group (ECOG) performance status =< 1

- Hemoglobin >= 9.0 g/L (within 4 weeks before registration)

- Leukocytes >= 3,000/mcL (within 4 weeks before registration)

- Absolute neutrophil count >= 1,500/mcL (within 4 weeks before registration)

- Platelets >= 100,000/mcL (within 4 weeks before registration)

- Total bilirubin < 1.5 x upper limit of normal (ULN) if no liver metastases or =< 3
times ULN in the presence of documented Gilbert's syndrome (unconjugated
hyperbilirubinemia) or liver metastases (within 4 weeks before registration)

- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 3 x institutional upper limit of normal; for patients with known hepatic metastases
AST and/or ALT =< 5 x ULN (within 4 weeks before registration)

- Creatinine =< 1.5 x institutional upper limit of normal (within 4 weeks before
registration)

- Participants may not have clinically active or symptomatic interstitial lung disease
or interstitial pneumonitis (i.e., affecting activities of daily living or requiring
therapeutic intervention), or a history of clinically significant interstitial lung
disease or radiation pneumonitis

- Participants may not have had radiation to the lung fields within four weeks (28 days)
of starting treatment; for patients receiving palliative radiation to thoracic
vertebrae, ribs or other sites where the radiation field includes the lungs, radiation
must be completed at least two weeks before starting treatment; for all palliative
radiation to all other sites, at least 7 days must have elapsed prior to starting to
treatment; at least six months (180 days) must have elapsed from radiation given with
curative intent

- Participants may not have clinically symptomatic brain metastases or leptomeningeal
disease; patients may be on a stable dose of corticosteroids to control brain
metastases if they have been on a stable dose for two weeks (14 days) prior to study
treatment and are clinically asymptomatic

- Patients must have an echocardiogram (ECHO) or a nuclear study (multi-gated
acquisition scan [MUGA] or first pass) within 4 weeks (28 days) prior to registration
to treatment and must not have a left ventricular ejection fraction (LVEF) <
institutional lower limit of normal (LLN); if the LLN is not defined at a site, the
LVEF must be >= 50% for the patient to be eligible

- Participants may not have any of the following cardiac criteria:

- Mean resting corrected QT interval (QTc) >= 470 msec obtained from 3
electrocardiograms (ECGs) using the screening clinic ECG machine-derived QTc
value

- No history of QT prolongation associated with other medications that required
discontinuation of that medication

- Patient must not be receiving any concomitant medications that are known to be
associated with Torsades de Pointes

- Any clinically important abnormalities in rhythm, conduction or morphology of
resting ECG e.g., complete left bundle branch block, third degree heart block,
second degree heart block, any factors that increase the risk of QTc prolongation
or risk of arrhythmic events such as heart failure, hypokalemia, congenital long
QT syndrome, family history of long QT syndrome or unexplained sudden death under
40 years of age in first degree relatives or any concomitant medication known to
prolong the QT interval

- Symptomatic heart failure - New York Heart Association (NYHA) grade II-IV

- Participants may not have a second, clinically active, cancer; patients with second
cancers which have been treated with curative intent and/or are currently inactive are
allowed

- Participants may not be receiving any other investigational agents; patients
previously treated with investigational agents must complete a washout period of at
least two weeks or five half-lives, whichever is longer, before starting treatment

- Participants may not have uncontrolled intercurrent illness including, but not limited
to, ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements

- No history of hypersensitivity active or inactive excipients of AZD9291 (osimertinib)
or drugs with a similar chemical structure or class to AZD9291 (osimertinib)

- Patients must not currently be receiving (or unable to stop use prior to receiving the
first dose of study treatment) medications or herbal supplements known to be potent
inducers of CYP3A4 (at least 3 week prior); all patients must try to avoid concomitant
use of any medications, herbal supplements and/or ingestion of foods with known
inducer effects on CYP3A4

- If medically feasible, patients taking regular medication, with the exception of
potent inducers of CYP3A4, should be maintained on it throughout the study period;
patients taking concomitant medications whose disposition is dependent upon breast
cancer resistance protein (BCRP) and which have a narrow therapeutic index should be
closely monitored for signs of changed tolerability as a result of increased exposure
of the concomitant medication whilst receiving AZD9291 (osimertinib) NOTE: Use of St
John's wort is a contra-indication for AZD9291 (osimertinib) use

- It is recommended that the starting and maintenance dose of rosuvastatin (due to BCRP
inhibition by AZD9291 [osimertinib]) should be as low as possible and should be guided
by the statin label; monitoring of low-density lipoprotein (LDL) cholesterol levels is
advised; if the subject experiences any potentially relevant adverse events suggestive
of muscle toxicity including unexplained muscle pain, tenderness, or weakness,
particularly if accompanied by malaise or fever, the statin should be stopped,
creatine kinase (CK) levels should be checked, and any appropriate further management
should be taken

- Subjects taking warfarin should be monitored regularly for changes in prothrombin time
or international normalized ratio (INR)

- No unresolved toxicities from prior therapy greater than Common Terminology Criteria
for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the
exception of alopecia and grade 2, prior platinum-therapy-related neuropathy

- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to
swallow the formulated product or previous significant bowel resection that would
preclude adequate absorption of AZD9291 (osimertinib)

- Women must not be pregnant or breast-feeding; all females of childbearing potential
must have a blood test or urine study within 2 weeks prior to registration to rule out
pregnancy; a female of childbearing potential is any woman, regardless of sexual
orientation or whether they have undergone tubal ligation, who meets the following
criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not
been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses
at any time in the preceding 24 consecutive months)

- Women of childbearing potential (WOCBP) and sexually active males must use an accepted
and effective method of contraception while receiving protocol treatment or abstain
from sexual intercourse for the duration of their participation in the study; WOCBP
must use birth control for two weeks prior to the start of the treatment and continue
for 6 weeks after the last dose of the study drug; sexually active male patients must
use effective contraception from day 1 of treatment and continue for 4 months after
the last dose of the study drug

- Other anticancer agents and investigational agents should not be given while the
subject is on study treatment

- Supportive care and other medications that are considered necessary for the subject's
wellbeing may be given at the discretion of the investigator

- A guidance regarding potential interactions with concomitant medications is provided
We found this trial at
297
sites
501 E Grant
Macomb, Illinois 61455
309-833-3503
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
(484) 884-2200
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Zofia Piotrowska
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Zofia Piotrowska
Phone: 617-667-9925
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Grace K. Dy
Phone: 800-767-9355
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
Principal Investigator: Richard D. Hall
Phone: 434-243-6303
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
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Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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100 Michigan Street Northeast
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524 South Park Street
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Phone: 616-391-1230
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
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(269) 382-2500
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4805 Northeast Glisan Street
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Seattle, Washington 98104
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Aberdeen, Washington 98520
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Allentown, Pennsylvania 18103
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Anaconda, Montana 59711
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Anchorage, Alaska 98508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 99504
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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Atlanta, Georgia 30322
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Phone: 404-778-1868
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Atlanta, Georgia 30342
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550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Principal Investigator: Suchita Pakkala
Phone: 888-946-7447
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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2000 Ogden Ave
Aurora, Illinois 60504
(630) 978-6200
Principal Investigator: Yujie Zhao
Phone: 630-978-6212
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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3325 Pocahontas Road
Baker City, Oregon 97814
Principal Investigator: Benjamin T. Marchello
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Ballwin, Missouri 63011
Principal Investigator: Jay W. Carlson
Phone: 314-251-7058
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Baltimore, Maryland 21237
Principal Investigator: Deepa S. Subramaniam
Phone: 443-777-7364
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Baton Rouge, Louisiana 70809
Principal Investigator: Suma P. Satti
Phone: 225-761-5346
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Baton Rouge, Louisiana 70816
Principal Investigator: Suma P. Satti
Phone: 225-761-5346
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Baton Rouge, Louisiana 70836
Principal Investigator: Suma P. Satti
Phone: 504-703-8712
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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3535 Pentagon Boulevard
Beavercreek, Ohio 45431
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Bellingham, Washington 98225
Principal Investigator: Alison K. Conlin
Phone: 360-715-4133
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Bend, Oregon 97701
Principal Investigator: Alison K. Conlin
Phone: 541-706-2909
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Boardman, Ohio 44512
Principal Investigator: Howard M. Gross
Phone: 330-629-7500
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Boise, Idaho 83706
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Alison K. Conlin
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Bonne Terre, Missouri 63628
Principal Investigator: Bryan A. Faller
Phone: 314-996-5569
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Principal Investigator: Zofia Piotrowska
Phone: 877-726-5130
Massachusetts General Hospital Cancer Center An integral part of one of the world
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Zofia Piotrowska
Phone: 877-442-3324
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
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Branson, Missouri 65616
Principal Investigator: Jay W. Carlson
Phone: 417-269-4520
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7575 Grand River Avenue
Brighton, Michigan 48114
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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7575 Grand River Avenue
Brighton, Michigan 48114
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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130 S Bryn Mawr Ave
Bryn Mawr, Pennsylvania 19010
(484) 337-3000
Principal Investigator: Albert S. DeNittis
Phone: 484-476-2649
Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
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Burbank, California
Principal Investigator: Alison K. Conlin
Phone: 818-847-4793
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Burlington, Wisconsin 53105
Principal Investigator: Shamsuddin Virani
Phone: 414-302-2304
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Principal Investigator: David M. King
Phone: 952-993-1517
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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3123 Medical Dr
Caldwell, Idaho 83605
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
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1600 South Canton Center Road
Canton, Michigan 48188
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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1600 South Canton Center Road
Canton, Michigan 48188
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
Principal Investigator: Bryan A. Faller
Phone: 573-334-2230
Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
(573) 519-4725
Principal Investigator: Bryan A. Faller
Phone: 573-651-5550
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Carbondale, Illinois 62902
Principal Investigator: Bryan A. Faller
Phone: 618-457-5200
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401 North Hooper Street
Caro, Michigan 48723
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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Carterville, Illinois 62918
Principal Investigator: Bryan A. Faller
Phone: 618-985-3333
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160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Centerville, Ohio 45459
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Centerville, Ohio 45459
Principal Investigator: Howard M. Gross
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Centralia, Illinois 62801
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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Centralia, Washington 98531
Principal Investigator: Alison K. Conlin
Phone: 360-412-8958
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14650 East Old US Highway 12
Chelsea, Michigan 48118
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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775 South Main Street
Chelsea, Michigan 48118
Principal Investigator: Philip J. Stella
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12961 27th Ave
Chippewa Falls, Wisconsin 54729
715-738-3700
Principal Investigator: Chady A. Leon
Phone: 800-782-8581
Marshfield Clinic - Chippewa Center The 15,000 square foot Lake Hallie Center provides urgent care...
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Cincinnati, Ohio 45236
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
(503) 513-3300
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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Clackamas, Oregon 97015
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
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5680 Bow Pointe Drive
Clarkston, Michigan 48346
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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31500 Telegraph Road
Clarkston, Michigan 48346
Principal Investigator: Philip J. Stella
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Bruce J. Averbook
Phone: 216-778-8526
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Cleveland, OH
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Cody, Wyoming 82414
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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Cody, WY
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Coeur d'Alene, Idaho 83814
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Coeur d'Alene, ID
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Collegeville, Pennsylvania 19426
Principal Investigator: Albert S. DeNittis
Phone: 484-476-2649
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Collegeville, PA
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Principal Investigator: David M. King
Phone: 952-993-1517
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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Coos Bay, Oregon 97420
Principal Investigator: Alison K. Conlin
Phone: 541-269-8392
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Coos Bay, OR
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Corvallis, Oregon 97330
Principal Investigator: David M. Hufnagel
Phone: 541-768-4352
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Corvallis, OR
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Danville, Illinois 61832
Principal Investigator: Yujie Zhao
Phone: 800-446-5532
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Danville, IL
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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Dayton, OH
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2222 Philadelphia Dr
Dayton, Ohio 45406
(937) 734-2612
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Good Samaritan Hospital - Dayton Good Samaritan Hospital (GSH) is passionate about providing the most...
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Dayton, OH
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Dayton, Ohio 45415
Principal Investigator: Howard M. Gross
Phone: 937-832-1093
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Dayton, OH
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Dayton, Ohio 45415
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Dayton, OH
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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Decatur, IL
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210 West McKinley Avenue
Decatur, Illinois 62526
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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Decatur, IL
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1200 Pleasant St
Des Moines, Iowa 50309
(515) 241-6212
Principal Investigator: Robert J. Behrens
Phone: 515-241-6727
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
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Des Moines, IA
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Des Moines, Iowa 50309
Principal Investigator: Robert J. Behrens
Phone: 515-282-2921
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Des Moines, IA
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Des Moines, Iowa 50314
Principal Investigator: Robert J. Behrens
Phone: 515-282-2200
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700 E University Ave
Des Moines, Iowa 50316
(515) 263-5612
Principal Investigator: Robert J. Behrens
Phone: 515-241-8704
Iowa Lutheran Hospital Iowa Lutheran Hospital has a long history of serving the Des Moines...
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Detroit, Michigan 48236
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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17900 23 Mile Road
East China Township, Michigan 48054
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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East China Township, MI
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East Stroudsburg, Pennsylvania 18301
Principal Investigator: Philip J. Stella
Phone: 570-422-1700
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Eau Claire, Wisconsin 54701
Principal Investigator: Chady A. Leon
Phone: 800-782-8581
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Principal Investigator: David M. King
Phone: 952-993-1517
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Edina, MN
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Edmonds, Washington 98026
Principal Investigator: Alison K. Conlin
Phone: 206-215-3086
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Effingham, Illinois 62401
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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