An Open-Label Phase 1/2 Study of INCB039110 in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

  • STATUS
    Recruiting
  • sponsor
    Incyte
Updated on 8 December 2020
cancer
tyrosine
systemic therapy
lung cancer
kinase inhibitor
KIT
EGFR
cancer chemotherapy
adjuvant chemotherapy
advanced lung cancer
osimertinib
lung carcinoma

Summary

An Open-Label Phase 1/2 Study of INCB039110 in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Description

The purpose of this study is to evaluate the safety and tolerability of INCB039110 in combination with osimertinib in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).

For more information, please contact Incyte Corporation at 1.855.463.3463

Details
Condition Non-Small Cell Lung Cancer, Lung Cancer
Clinical Study IdentifierTX146448
SponsorIncyte
Last Modified on8 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 0 yrs?
Gender: Male or Female
Do you have Non-Small Cell Lung Cancer?
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
Radiographically measurable or evaluable disease per RECIST v1.1

Exclusion Criteria

Known active central nervous system (CNS) metastases. Subjects with CNS metastases who have completed a course of therapy would be eligible provided that they are clinically stable for at least 4 weeks before study entry, defined as follows
No evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases
Subjects who are receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 4 weeks before first dose of study treatment and off anticonvulsants for at least 4 weeks before study entry
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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