An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:November 2016
End Date:February 2020
Contact:Incyte Corporation Call Center
Phone:1.855.463.3463

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An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

The purpose of this study is to evaluate the safety and tolerability of itacitinib in
combination with osimertinib in subjects with locally advanced or metastatic non-small cell
lung cancer (NSCLC).


Inclusion Criteria:

- 18 years of age or older at screening; outside the U.S. and European Union, an older
limit could apply depending on local regulation (eg, 19 years and older for South
Korea and 20 years and older for Taiwan).

- Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB)
or metastatic (Stage IV) NSCLC.

- Documented evidence of somatic activating mutation in EGFR (eg, G719X, exon 19
deletion, L858R, L861Q) in a tumor tissue sample. If a tissue sample is not available,
then EGFR mutation status may be determined from circulating tumor DNA obtained from a
blood sample using a validated or approved test kit.

- Phase 1: Subjects must have previously received and progressed on or after
treatment with an EGFR tyrosine kinase inhibitor (TKI). Additional lines of
systemic therapy including investigational agents for locally advanced or
metastatic NSCLC are allowed.

- Phase 2: Subjects must not have received more than 1 prior line of therapy for
locally advanced or metastatic NSCLC. First-line treatment must include an EGFR
TKI, and subjects must have documented disease progression during or following
treatment. Subjects with disease that progressed more than 6 months after
completion of neoadjuvant/adjuvant chemotherapy or chemoradiation therapy are
eligible if they received an EGFR TKI as first-line treatment for advanced NSCLC.

- Subjects must have evidence of a T790M mutation in tumor tissue or plasma
obtained after disease progression during or after treatment with an EGFR
TKI. T790M mutation status from a local laboratory is acceptable; however, a
tumor tissue sample or plasma sample suitable for centralized T790M mutation
analysis must be available.

- Radiographically measurable or evaluable disease per RECIST v1.1.

Exclusion Criteria:

- Known CNS metastases, unless stable and asymptomatic. Subjects with CNS metastases may
be eligible for the study, provided:

- There is no evidence of new or enlarging CNS metastasis or new neurological
symptoms attributable to CNS metastases.

- Subjects who are receiving corticosteroids must be on a stable or decreasing dose
for at least 4 weeks before first dose of study treatment.

- Laboratory parameters outside the protocol-defined range.

- Clinically significant abnormalities found on an ECG.

- Clinically significant or uncontrolled cardiac disease.

- Past history of interstitial lung disease (ILD), drug induced ILD, radiation
pneumonitis that required steroid treatment, or any evidence of clinically active ILD.

- Current or previous other malignancy within 2 years of study entry, except cured basal
or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial
neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy.

- Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery,
immunotherapy, biologic therapy, or hormonal therapy).

- Any previous use of Janus kinase (JAK) inhibitor, osimertinib, or other EGFR-directed
therapy for T790M-mt NSCLC.
We found this trial at
24
sites
New York, New York 10016
Principal Investigator: Dr. Elaine Shum
Phone: 212-404-3796
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901 West 38th Street
Austin, Texas 78705
Principal Investigator: Dr. Jason Melear
Phone: 512-421-4143
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Austin, TX
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701 Northwest 13th Street
Boca Raton, Florida 33486
Principal Investigator: Dr. Edgardo S. Santos
Phone: 561-955-5630
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450 Brookline Avenue
Boston, Massachusetts 02215
Principal Investigator: Dr. Geffory Oxnard
Phone: 617-632-6485
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Boston, MA
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9500 Euclid Avenue
Cleveland, Ohio 44195
Principal Investigator: Dr. Nathan Pennell
Phone: 216-444-9649
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Cleveland, OH
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Denver, Colorado 80124
Principal Investigator: Dr. Robert Jotte
Phone: 303-285-5075
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2799 West Grand Boulevard
Detroit, Michigan 48202
Principal Investigator: Dr. Igor Rybkin
Phone: 313-916-4987
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Detroit, MI
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4100 John R Street
Detroit, Michigan 48202
Principal Investigator: Dr. Misako Nagasaka
Phone: 313-576-9810
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Detroit, MI
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8503 Arlington Boulevard
Fairfax, Virginia 22031
Principal Investigator: Dr. Alexander Spira
Phone: 703-208-9268
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701 Ostrum Street
Fountain Hill, Pennsylvania 18015
Principal Investigator: Dr. Neil Belman
Phone: 484-503-4151
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1515 Holcombe Boulevard
Houston, Texas 77030
Principal Investigator: Dr. Vassiliki Papadimitrakopoulou
Phone: 713-792-3279
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La Jolla, California 92093
Principal Investigator: Dr. Lyudmila Bazhenova
Phone: 858-246-0375
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1 Medical Center Drive
Morgantown, West Virginia 26506
Principal Investigator: Dr. Patrick Ma
Phone: 304-581-1158
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111 South 11th Street
Philadelphia, Pennsylvania 19107
Principal Investigator: Dr. Ralph G. Zinner
Phone: 215-955-1964
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4805 Northeast Glisan Street
Portland, Oregon 97213
Principal Investigator: Dr. Rachel Sanborn
Phone: 503-215-2613
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223 North Van Dien Avenue
Ridgewood, New Jersey 07450
Principal Investigator: Dr. Eli Kirshner
Phone: 201-634-5791
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2000 Circle of Hope Drive
Salt Lake City, Utah 84112
Principal Investigator: Dr. Wallace Akerley
Phone: 801-587-4746
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5206 Research Drive
San Antonio, Texas 78240
Principal Investigator: Dr. Sridhar Beeram
Phone: 309-236-2615
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San Francisco, California 94115
Principal Investigator: Dr. Collin Blakely
Phone: 415-353-1669
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Seoul, Seocho-gu 06591
Principal Investigator: Jin Hyoung Kang
Phone: +82-2-2258-6802
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3 Edmund D. Pellegrino Road
Stony Brook, New York 11794
Principal Investigator: Dr. Roger S. Keresztes
Phone: 631-638-0837
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910 East Houston Street
Tyler, Texas 75702
Principal Investigator: Dr. Donald Richards
Phone: 903-579-9800
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3800 Reservoir Road Northwest
Washington, District of Columbia 20007
Principal Investigator: Dr. Deepa Subramanian
Phone: 202-687-8961
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15111 Whittier Boulevard
Whittier, California 15111
Principal Investigator: Dr. Merrill Shum
Phone: 562-693-4477
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