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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

December 20, 2016

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Lung Cancer
Interventions
DRUG

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.

DRUG

Osimertinib

Osimertinib 80 mg once daily (QD)

Trial Locations (31)

10002

National Taiwan University Hospital, 7 Zhongshan South Road, Taipei

10016

NYU Langone Medical Center, 160 East 34th Street, Floor 8, New York

11217

Taipei Veterans General Hospital, No.201 Sec. 2 Shipai Rd l, Taipei

11794

Stony Brook University Medical Center, 3 Edmund D. Pellegrino Road, Stony Brook

18015

St. Luke's University Health Network, 701 Ostrum Street, Suite 403, Fountain Hill

19107

Thomas Jefferson University, 111 S. 11th Street, Philadelphia

20007

Georgetown University Hospital, 3800 Reservoir Rd, NW, Washington D.C.

22031

US Oncology-Virginia Cancer Specialists, PC, 8503 Arlington Blvd., Suite 400, Fairfax

26506

West Virginia University Cancer Institute, 1 Medical Center Drive, Morgantown

28034

Hospital Ramón y Cajal Ctra. Colmenar Viejo Km. 9,1 Planta (-)2 Dcha Oficina de Ensayos Clínicos Servicio de Oncología Médica, Madrid

33486

Lynn Cancer Center, 701 NW 13th Street, Floor 2, Boca Raton

44195

Cleveland Clinic, 9500 Euclid Avenue, G Building, Cleveland

46010

Hospital Clinico Universitario Valencia Avenida Blasco Ibáñez 17 -8º, Valencia

48202

Henry Ford Health System, 2799 W Grand Blvd., Detroit

Karmanos Cancer Institute, 4100 John R. street mail Code HW04HO, Detroit

75702

Texas Oncology-Tyler, 910 E Houston Street, Suite 100, Tyler

77030

University of Texas -MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston

78240

Texas Oncology - San Antonio Medical, 5206 Research Drive, San Antonio

78705

Texas Oncology - South Austin, 901 West 38th Street, Suite 200, Austin

80124

Rocky Mountain Cancer Center, 1800 Williams Street, Suite 200, Denver

84112

Huntsman Cancer Institute, 2000 Circle of Hope Drive, Salt Lake City

90603

Innovative Clinical Research Institute, 15111 Whittier Blvd., Suite 216, Whittier

92093

University of California San Diego, 3855 Health Sciences Drive, Mc 0987, La Jolla

94115

University California San Francisco Thoracic Surgery and Oncology Clinic, 1600 Divisadero Street, Floor 4, San Francisco

97213

Earle A. Chiles Research Institute Providence Cancer Center, 4805 NE Glisan Street, 2N35, Portland

02215

Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston

07450

Valley Hospital, 223 N Van Dien Avenue, Ridgewood

06591

The catholic University of Korea, Seoul St. Mary's hospital, 222 Banpo-daero, Seoul

03722

Severance Hospital, Yonsei University Health System 50-1 Yonsei-ro, Seoul

05505

Asan Medical Center Department of Oncology, 88, Olympic-ro 43-gil, Seoul

08035

Antiga Guarderia-Servei d'Oncologia Hospital Vall d'Hebron. P.Vall Hebron 119-129, Barcelona

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Incyte Corporation

INDUSTRY