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

Who is this study for? Patients with locally advanced or metastatic non-small cell lung cancer
What treatments are being studied? Itacitinib+Osimertinib
Status: Active_not_recruiting
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California San Diego, 3855 Health Sciences Drive, Mc 0987
La Jolla
University California San Francisco Thoracic Surgery and Oncology Clinic, 1600 Divisadero Street, Floor 4
San Francisco
Innovative Clinical Research Institute, 15111 Whittier Blvd., Suite 216
Whittier
Colorado
Rocky Mountain Cancer Center, 1800 Williams Street, Suite 200
Denver
Washington, D.c.
Georgetown University Hospital, 3800 Reservoir Rd, NW
Washington
Florida
Lynn Cancer Center, 701 NW 13th Street, Floor 2
Boca Raton
Massachusetts
Dana-Farber Cancer Institute, 450 Brookline Avenue
Boston
Michigan
Henry Ford Health System, 2799 W Grand Blvd.
Detroit
Karmanos Cancer Institute, 4100 John R. street mail Code HW04HO
Detroit
New Jersey
Valley Hospital, 223 N Van Dien Avenue
Ridgewood
New York
NYU Langone Medical Center, 160 East 34th Street, Floor 8
New York
Stony Brook University Medical Center, 3 Edmund D. Pellegrino Road
Stony Brook
Ohio
Cleveland Clinic, 9500 Euclid Avenue, G Building
Cleveland
Oregon
Earle A. Chiles Research Institute Providence Cancer Center, 4805 NE Glisan Street, 2N35
Portland
Pennsylvania
St. Luke's University Health Network, 701 Ostrum Street, Suite 403
Fountain Hill
Thomas Jefferson University, 111 S. 11th Street
Philadelphia
Texas
Texas Oncology - South Austin, 901 West 38th Street, Suite 200
Austin
University of Texas -MD Anderson Cancer Center, 1515 Holcombe Blvd.
Houston
Texas Oncology - San Antonio Medical, 5206 Research Drive
San Antonio
Texas Oncology-Tyler, 910 E Houston Street, Suite 100
Tyler
Utah
Huntsman Cancer Institute, 2000 Circle of Hope Drive
Salt Lake City
Virginia
US Oncology-Virginia Cancer Specialists, PC, 8503 Arlington Blvd., Suite 400
Fairfax
West Virginia
West Virginia University Cancer Institute, 1 Medical Center Drive
Morgantown
Other Locations
Republic of Korea
Asan Medical Center Department of Oncology, 88, Olympic-ro 43-gil
Seoul
Severance Hospital, Yonsei University Health System 50-1 Yonsei-ro
Seoul
The catholic University of Korea, Seoul St. Mary's hospital, 222 Banpo-daero
Seoul
Spain
Antiga Guarderia-Servei d'Oncologia Hospital Vall d'Hebron. P.Vall Hebron 119-129
Barcelona
Hospital Ramón y Cajal Ctra. Colmenar Viejo Km. 9,1 Planta (-)2 Dcha Oficina de Ensayos Clínicos Servicio de Oncología Médica
Madrid
Hospital Clinico Universitario Valencia Avenida Blasco Ibáñez 17 -8º
Valencia
Taiwan
National Taiwan University Hospital, 7 Zhongshan South Road
Taipei
Taipei Veterans General Hospital, No.201 Sec. 2 Shipai Rd l
Taipei City
Time Frame
Start Date: 2016-12-20
Completion Date: 2025-12-31
Participants
Target number of participants: 59
Treatments
Experimental: Itacitinib + osimertinib
Sponsors
Collaborators: AstraZeneca
Leads: Incyte Corporation

This content was sourced from clinicaltrials.gov