An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer
NCT ID: NCT02917993
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
59 participants
INTERVENTIONAL
2016-12-20
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Itacitinib + osimertinib
Itacitinib
In Phase 1, itacitinib at a protocol-defined starting dose, with subsequent dose escalation based on protocol-specific criteria. In Phase 2, itacitinib at the recommended dose from Phase 1.
Osimertinib
Osimertinib 80 mg once daily (QD)
Interventions
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Itacitinib
In Phase 1, itacitinib at a protocol-defined starting dose, with subsequent dose escalation based on protocol-specific criteria. In Phase 2, itacitinib at the recommended dose from Phase 1.
Osimertinib
Osimertinib 80 mg once daily (QD)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Langmuir
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Texas Oncology - South Austin, 901 West 38th Street, Suite 200
Austin, Texas, United States
University of Texas -MD Anderson Cancer Center, 1515 Holcombe Blvd.
Houston, Texas, United States
Texas Oncology - San Antonio Medical, 5206 Research Drive
San Antonio, Texas, United States
Texas Oncology-Tyler, 910 E Houston Street, Suite 100
Tyler, Texas, United States
Huntsman Cancer Institute, 2000 Circle of Hope Drive
Salt Lake City, Utah, United States
University of California San Diego, 3855 Health Sciences Drive, Mc 0987
La Jolla, California, United States
University California San Francisco Thoracic Surgery and Oncology Clinic, 1600 Divisadero Street, Floor 4
San Francisco, California, United States
Innovative Clinical Research Institute, 15111 Whittier Blvd., Suite 216
Whittier, California, United States
Rocky Mountain Cancer Center, 1800 Williams Street, Suite 200
Denver, Colorado, United States
Georgetown University Hospital, 3800 Reservoir Rd, NW
Washington D.C., District of Columbia, United States
Lynn Cancer Center, 701 NW 13th Street, Floor 2
Boca Raton, Florida, United States
Dana-Farber Cancer Institute, 450 Brookline Avenue
Boston, Massachusetts, United States
Henry Ford Health System, 2799 W Grand Blvd.
Detroit, Michigan, United States
Karmanos Cancer Institute, 4100 John R. street mail Code HW04HO
Detroit, Michigan, United States
Valley Hospital, 223 N Van Dien Avenue
Ridgewood, New Jersey, United States
NYU Langone Medical Center, 160 East 34th Street, Floor 8
New York, New York, United States
Stony Brook University Medical Center, 3 Edmund D. Pellegrino Road
Stony Brook, New York, United States
Cleveland Clinic, 9500 Euclid Avenue, G Building
Cleveland, Ohio, United States
Earle A. Chiles Research Institute Providence Cancer Center, 4805 NE Glisan Street, 2N35
Portland, Oregon, United States
St. Luke's University Health Network, 701 Ostrum Street, Suite 403
Fountain Hill, Pennsylvania, United States
Thomas Jefferson University, 111 S. 11th Street
Philadelphia, Pennsylvania, United States
US Oncology-Virginia Cancer Specialists, PC, 8503 Arlington Blvd., Suite 400
Fairfax, Virginia, United States
West Virginia University Cancer Institute, 1 Medical Center Drive
Morgantown, West Virginia, United States
The catholic University of Korea, Seoul St. Mary's hospital, 222 Banpo-daero
Seoul, Seocho-gu, South Korea
Severance Hospital, Yonsei University Health System 50-1 Yonsei-ro
Seoul, Seodaemun-gu, South Korea
Asan Medical Center Department of Oncology, 88, Olympic-ro 43-gil
Seoul, Songpa-gu, South Korea
Antiga Guarderia-Servei d'Oncologia Hospital Vall d'Hebron. P.Vall Hebron 119-129
Barcelona, , Spain
Hospital Ramón y Cajal Ctra. Colmenar Viejo Km. 9,1 Planta (-)2 Dcha Oficina de Ensayos Clínicos Servicio de Oncología Médica
Madrid, , Spain
Hospital Clinico Universitario Valencia Avenida Blasco Ibáñez 17 -8º
Valencia, , Spain
Taipei Veterans General Hospital, No.201 Sec. 2 Shipai Rd l
Taipei, Beitou District, Taiwan
National Taiwan University Hospital, 7 Zhongshan South Road
Taipei, Zhongzheng District, Taiwan
Countries
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Related Links
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An Open-Label Phase 1/ 2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer
Other Identifiers
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2017-001750-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 39110-207
Identifier Type: -
Identifier Source: org_study_id
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