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

Completed · Phase 1/Phase 2

Conditions studied: Lung Cancer

In brief

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 facts

Study ID: NCT02917993
Run by: Incyte Corporation
People needed: 59
Starts: 2016-12-20
Expected to finish: 2025-12-24
Last updated by the study team: 2026-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

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
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
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

Full record on ClinicalTrials.gov

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