Small Cell Lung Cancer

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

Incyte Study ID:
INCB 39110-207
CT.gov ID:
NCT02917993
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
AstraZeneca
Study Contact Information:
1.855.463.3463
Recruitment Complete
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Clinical Study Purpose

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).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Small Cell Lung Cancer
    • PRODUCT
  • Drug: Itacitinib
  • Drug: Osimertinib
    • COLLABORATORS
    AstraZeneca
    DATE
    Dec 2016 - Dec 2025
    TYPE
    Interventional
    PHASE
    Phase 1/Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    University of California San Diego, 3855 Health Sciences Drive, Mc 0987
    La Jolla, California, US, 92093
    Name
    University California San Francisco Thoracic Surgery and Oncology Clinic, 1600 Divisadero Street, Floor 4
    San Francisco, California, US, 94115
    Name
    Innovative Clinical Research Institute, 15111 Whittier Blvd., Suite 216
    Whittier, CA, US, 90603
    Name
    Rocky Mountain Cancer Center, 1800 Williams Street, Suite 200
    Denver, Colorado, US, 80124
    Name
    Georgetown University Hospital, 3800 Reservoir Rd, NW
    Washington, DC, US, 20007
    Name
    Lynn Cancer Center, 701 NW 13th Street, Floor 2
    Boca Raton, FL, US, 33486

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • 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.

    Exclusion Criteria

    • Known CNS metastases, unless stable and asymptomatic. Subjects with CNS metastases may be eligible for the study, provided:
    • o There is no evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.

    Protocol Summary

    Incyte Study ID:
    INCB 39110-207
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    59
    Primary Outcome
    Open

    Phase 1: Frequency, severity, and duration of adverse events (AEs)

    Timeframe: From screening through 30-35 days after end of treatment, approximately 2 years.

    Phase 1: Number of subjects with dose-limiting toxicities (DLTs)

    Timeframe: Day 1 through Day 28

    Phase 2: Objective response rate (ORR) based on RECIST v1.1

    Timeframe: Screening and 8-week intervals throughout the study, approximately 2 years.

    Secondary Outcome
    Open

    Phase 1 and Phase 2: Maximum plasma concentration (Cmax) of itacitinib and osimertinib when administered in combination

    Timeframe: Measured at protocol-defined study visits from Cycle 1 Day 1 through Cycle 1 Day 28.

    Phase 1 and Phase 2: Area under the plasma concentration-time curve (AUC) of Itacitinib and osimertinib when administered in combination

    Timeframe: Measured at protocol-defined study visits from Cycle 1 Day 1 through Cycle 1 Day 28.

    Phase 2: Depth of response (DpR) based on RECIST v1.1

    Timeframe: Screening and 8-week intervals throughout the study, approximately 2 years.

    Phase 2: Progression-free survival (PFS)

    Timeframe: Interval from the first day of study treatment until disease progression or death due to any cause, approximately 3 years.

    Phase 2: Overall survival (OS)

    Timeframe: Interval from the first day of study treatment until death due to any cause, approximately 3 years.

    Phase 2: Frequency, severity, and duration of AEs

    Timeframe: From screening through 30-35 days after end of treatment, approximately 2 years.