Non Small Cell Lung Cancer

Ruxolitinib in Combination with Pemetrexed/Cisplatin in Non Small Cell Lung Cancer

Incyte Study ID:
INCB 18424-266
CT.gov ID:
NCT02119650
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1-855-463-3463
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Clinical Study Purpose

The purpose of this study was to determine if ruxolitinib, in combination with Pemetrexed/Cisplatin and Pemetrexed Maintenance, is safe and effective in the treatment of nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Non Small Cell Lung Cancer
    • PRODUCT
  • Drug: Ruxolitinib
  • Drug: Placebo
  • Drug: Pemetrexed
  • Drug: Cisplatin
    • COLLABORATORS
    N/A
    DATE
    Feb 2014 - Feb 2016
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Histologically or cytologically confirmed diagnosis of nonsquamous NSCLC that is Stage IIIB Stage IV, or recurrent after prior definitive intervention (radiation, surgery, or chemoradiation therapy, with or without adjuvant or neoadjuvant chemotherapy).
    • Radiographically measurable or evaluable disease.

    Exclusion Criteria

    • Squamous or mixed histology (eg, adenosquamous) NSCLC
    • Previous systemic therapy for advanced or metastatic disease.

    Clinical Study Locations

    Location
    Status
    Location
    Fayetteville, AR, US
    Status
    Recruiting
    Location
    Joilet, IL, US
    Status
    Recruiting
    Location
    Canton, OH, US
    Status
    Recruiting
    Location
    Lafayette, Indiana, US
    Status
    Recruiting
    Location
    Southington, CT, US
    Status
    Recruiting
    Location
    Winston-Salem, NC, US
    Status
    Recruiting

    Protocol Summary

    Incyte Study ID:
    INCB 18424-266
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Double (Participant, Investigator)
    Interventions:
    Drug
    Enrollment:
    76
    Primary Outcome
    Open
    Secondary Outcome
    Open