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

Part of paid clinical trials in La Jolla, California.

Sponsor
Incyte Corporation
Study ID
NCT02917993
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Itacitinib — DRUG
    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 — DRUG
    Osimertinib 80 mg once daily (QD)

Study Details

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).

Key Dates

Start date
Dec 20, 2016
Status verified
Feb 2026
Primary completion
Dec 24, 2025
Completion
Dec 24, 2025

Study Design

Enrollment
59 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Itacitinib + osimertinib

Primary Outcome Measure

Phase 1: Frequency, severity, and duration of adverse events (AEs) [ Time Frame: From screening through 30-35 days after end of treatment, approximately 2 years. ]

Locations (23)

FacilityCityStateZIPSite coordinators
University of California San Diego, 3855 Health Sciences Drive, Mc 0987La JollaCalifornia92093-
University California San Francisco Thoracic Surgery and Oncology Clinic, 1600 Divisadero Street, Floor 4San FranciscoCalifornia94115-
Innovative Clinical Research Institute, 15111 Whittier Blvd., Suite 216WhittierCalifornia90603-
Rocky Mountain Cancer Center, 1800 Williams Street, Suite 200DenverColorado80124-
Georgetown University Hospital, 3800 Reservoir Rd, NWWashington D.C.District of Columbia20007-
Lynn Cancer Center, 701 NW 13th Street, Floor 2Boca RatonFlorida33486-
Dana-Farber Cancer Institute, 450 Brookline AvenueBostonMassachusetts02215-
Henry Ford Health System, 2799 W Grand Blvd.DetroitMichigan48202-
Karmanos Cancer Institute, 4100 John R. street mail Code HW04HODetroitMichigan48202-
Valley Hospital, 223 N Van Dien AvenueRidgewoodNew Jersey07450-
NYU Langone Medical Center, 160 East 34th Street, Floor 8New YorkNew York10016-
Stony Brook University Medical Center, 3 Edmund D. Pellegrino RoadStony BrookNew York11794-
Cleveland Clinic, 9500 Euclid Avenue, G BuildingClevelandOhio44195-
Earle A. Chiles Research Institute Providence Cancer Center, 4805 NE Glisan Street, 2N35PortlandOregon97213-
St. Luke's University Health Network, 701 Ostrum Street, Suite 403Fountain HillPennsylvania18015-
Thomas Jefferson University, 111 S. 11th StreetPhiladelphiaPennsylvania19107-
Texas Oncology - South Austin, 901 West 38th Street, Suite 200AustinTexas78705-
University of Texas -MD Anderson Cancer Center, 1515 Holcombe Blvd.HoustonTexas77030-
Texas Oncology - San Antonio Medical, 5206 Research DriveSan AntonioTexas78240-
Texas Oncology-Tyler, 910 E Houston Street, Suite 100TylerTexas75702-
Huntsman Cancer Institute, 2000 Circle of Hope DriveSalt Lake CityUtah84112-
US Oncology-Virginia Cancer Specialists, PC, 8503 Arlington Blvd., Suite 400FairfaxVirginia22031-
West Virginia University Cancer Institute, 1 Medical Center DriveMorgantownWest Virginia26506-

Find similar trials in La Jolla, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of California San Diego, 3855 Health Sciences Drive, Mc 0987· La Jolla, CAUniversity California San Francisco Thoracic Surgery and Oncology Clinic, 1600 Divisadero Street, Floor 4· San Francisco, CAInnovative Clinical Research Institute, 15111 Whittier Blvd., Suite 216· Whittier, CARocky Mountain Cancer Center, 1800 Williams Street, Suite 200· Denver, COGeorgetown University Hospital, 3800 Reservoir Rd, NW· Washington D.C., DCLynn Cancer Center, 701 NW 13th Street, Floor 2· Boca Raton, FL

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