Study Stopped
Sponsor decision to not initiate part 2 due to slow enrollment and competing trials.
Study of Itacitinib in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer
A Randomized, Phase 2 Study of Itacitinib or Placebo in Combination With Docetaxel in Subjects With Previously Treated Stage IIIb, IV, or Recurrent Non-Small Cell Lung Cancer
1 other identifier
interventional
9
1 country
16
Brief Summary
The primary objectives of this study were to evaluate the safety and tolerability of itacitinib in combination with docetaxel and to select doses for further evaluation (Part 1, safety run-in portion), and to evaluate and compare the overall survival of subjects with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) when treated with itacitinib in combination with docetaxel versus docetaxel alone (Part 2, randomized portion).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2014
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 24, 2014
CompletedFirst Submitted
Initial submission to the registry
September 26, 2014
CompletedFirst Posted
Study publicly available on registry
October 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2016
CompletedApril 21, 2026
April 1, 2026
1.4 years
September 26, 2014
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Dose Limiting Toxicities (DLTs)
Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD).
Baseline through 21 days; the end of cycle 1.
Study Arms (1)
Itacitinib plus docetaxel
EXPERIMENTALItacitinib 400 mg QD administered orally in combination with docetaxel 75 mg/m\^2 once every 3 weeks (q3w) administered intravenously
Interventions
Itacitinib tablets administered orally at 400 mg QD for Part 1 of the study.
Administered as an intravenous infusion in the clinic at 75 mg/m\^2 Q3W for Part 1 of the study.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed diagnosis of NSCLC that is Stage IIIb, IV, or recurrent.
- Received only 1 prior systemic chemotherapy regimen for Stage IIIb, IV, or recurrent disease not including neoadjuvant and/or adjuvant therapy. (NOTE: Exceptions may be allowed based on prior treatment regimens and tumor types in agreement with protocol requirements.)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Life expectancy of ≥12 weeks.
You may not qualify if:
- Received prior treatment with docetaxel.
- Known active central nervous system (CNS) metastases. Subjects with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to study entry, defined as:
- 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 prior to first dose of study treatment and off all anticonvulsants for at least 4 weeks prior to study entry.
- Peripheral neuropathy ≥ Grade 3.
- 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.
- Significant, concurrent, uncontrolled medical condition including but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
- Unwilling to be transfused with blood components.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Unknown Facility
Hot Springs, Arizona, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Pascagoula, Mississippi, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Lebanon, New Hampshire, United States
Unknown Facility
Goldsboro, North Carolina, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Gettysburg, Pennsylvania, United States
Unknown Facility
Hershey, Pennsylvania, United States
Unknown Facility
Pawtucket, Rhode Island, United States
Unknown Facility
Spartanburg, South Carolina, United States
Unknown Facility
Round Rock, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Amit Pande, M.D.
Incyte Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2014
First Posted
October 6, 2014
Study Start
September 24, 2014
Primary Completion
February 1, 2016
Study Completion
April 5, 2016
Last Updated
April 21, 2026
Record last verified: 2026-04