Study of Itacitinib in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer

Stopped early · Phase 2

Conditions studied: NSCLC (Non-small Cell Lung Carcinoma)

In brief

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).

Key facts

Study ID

NCT02257619

Run by

Incyte Corporation

People needed

9

Starts

2014-09-24

Expected to finish

2016-04-05

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Hot Springs, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Orlando, Florida, United States
• Study site — Detroit, Michigan, United States
• Study site — Pascagoula, Mississippi, United States
• Study site — Kansas City, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Goldsboro, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Gettysburg, Pennsylvania, United States
• Study site — Hershey, Pennsylvania, United States
• Study site — Pawtucket, Rhode Island, United States
• Study site — Spartanburg, South Carolina, United States
• Study site — Round Rock, Texas, United States

Full record on ClinicalTrials.gov

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