An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02917993|
Recruitment Status : Active, not recruiting
First Posted : September 28, 2016
Last Update Posted : February 21, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Itacitinib Drug: Osimertinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||December 20, 2016|
|Estimated Primary Completion Date :||December 21, 2023|
|Estimated Study Completion Date :||December 21, 2023|
|Experimental: Itacitinib + osimertinib||
In Phase 1, itacitinib at a protocol-defined starting dose, with subsequent dose escalation based on protocol-specific criteria. In Phase 2, itacitinib at the recommended dose from Phase 1.
Other Name: INCB039110
Osimertinib 80 mg once daily (QD)
- Phase 1: Frequency, severity, and duration of adverse events (AEs) [ Time Frame: From screening through 30-35 days after end of treatment, approximately 2 years. ]
- Phase 1: Number of subjects with dose-limiting toxicities (DLTs) [ Time Frame: Day 1 through Day 28 ]
- Phase 2: Objective response rate (ORR) based on RECIST v1.1 [ Time Frame: Screening and 8-week intervals throughout the study, approximately 2 years. ]ORR defined as the percentage of subjects who have a confirmed best overall response of complete response (CR) or partial response (PR).
- Phase 1 and Phase 2: Maximum plasma concentration (Cmax) of itacitinib and osimertinib when administered in combination [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Screening and 8-week intervals throughout the study, approximately 2 years. ]Defined as the percentage of maximal tumor shrinkage observed at the lowest point (nadir) compared with baseline.
- Phase 2: Progression-free survival (PFS) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: From screening through 30-35 days after end of treatment, approximately 2 years. ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917993
|Study Director:||Peter Langmuir||Incyte Corporation|
|Responsible Party:||Incyte Corporation|
|Other Study ID Numbers:||
|First Posted:||September 28, 2016 Key Record Dates|
|Last Update Posted:||February 21, 2023|
|Last Verified:||February 2023|
non-small cell lung cancer
epidermal growth factor receptor (EGFR) inhibition
Janus kinase inhibition
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action