NSCLC (Non-small Cell Lung Carcinoma)Phase 2NCT02257619
Study of Itacitinib in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer
A Phase 2 study testing Itacitinib and docetaxel in people with NSCLC (Non-small Cell Lung Carcinoma), run by Incyte Corporation at 16 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Non-small Cell Lung Carcinoma)
- What is being tested?
- Itacitinib and docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 16 sitesUnited States
- Study dates
- 24 Sep 2014to 5 Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Study site
Cleveland, Ohio
Study site
Detroit, Michigan
Study site
Gettysburg, Pennsylvania
Study site
Goldsboro, North Carolina
Study site
Hershey, Pennsylvania
Study site
Hot Springs, Arizona
Study site
Kansas City, Missouri
Study site
Lebanon, New Hampshire
Study site
Los Angeles, California
Study site
Omaha, Nebraska
Study site
Orlando, Florida
Study site
Pascagoula, Mississippi
Study site
Pawtucket, Rhode Island
Study site
Round Rock, Texas
Study site
Spartanburg, South Carolina
Study site
Washington D.C., District of Columbia
About this study
Official title: 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
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).
Read the detailed description
The secondary objectives of this study (Part 2) were to evaluate and compare the efficacy of the 2 treatment groups with respect to progression-free survival, overall tumor response, and duration of response, and to evaluate and compare disease control, safety, and tolerability of itacitinib in combination with docetaxel versus docetaxel alone.
Part 2 of the study was not conducted.
- Conditions
- NSCLC (Non-small Cell Lung Carcinoma)
- Being tested
- Itacitinib, docetaxel
- Keywords
- Stage IIIb, IV, or Recurrent Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItacitinibDrug
Also called INCB039110
Itacitinib tablets administered orally at 400 mg QD for Part 1 of the study.
docetaxelDrug
Administered as an intravenous infusion in the clinic at 75 mg/m^2 Q3W for Part 1 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Itacitinib plus docetaxel | Experimental | Itacitinib 400 mg QD administered orally in combination with docetaxel 75 mg/m^2 once every 3 weeks (q3w) administered intravenously Receives: Drug: Itacitinib; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities (DLTs)
Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD).
Measured: Baseline through 21 days; the end of cycle 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study start24 Sep 2014
- Primary completionFeb 2016
- Study completion5 Apr 2016
Why it stopped: Sponsor decision to not initiate part 2 due to slow enrollment and competing trials.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Carcinoma)Studies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amit Pande, M.D., Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257619
- Sponsor's protocol ID
- INCB 39110-203
- Status last verified
- Apr 2026
- First submitted
- 26 Sep 2014
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02257619
- Acronym / sponsor ID
- INCB 39110-203
- Conditions
- NSCLC (Non-small Cell Lung Carcinoma)
- Keywords
- Stage IIIb, IV, or Recurrent Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to not initiate part 2 due to slow enrollment and competing trials.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- 5 Apr 2016 (actual)
- First posted
- 6 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The secondary objectives of this study (Part 2) were to evaluate and compare the efficacy of the 2 treatment groups with respect to progression-free survival, overall tumor response, and duration of response, and to evaluate and compare disease control, safety, and tolerability of itacitinib in combination with docetaxel versus docetaxel alone.
Part 2 of the study was not conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Itacitinib plus docetaxel | Experimental | Drug: Itacitinib, Drug: docetaxelItacitinib 400 mg QD administered orally in combination with docetaxel 75 mg/m^2 once every 3 weeks (q3w) administered intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ItacitinibAlso: INCB039110Itacitinib tablets administered orally at 400 mg QD for Part 1 of the study. | Drug | Itacitinib plus docetaxel |
| docetaxelAdministered as an intravenous infusion in the clinic at 75 mg/m^2 Q3W for Part 1 of the study. | Drug | Itacitinib plus docetaxel |
Primary outcome
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Baseline through 21 days; the end of cycle 1.
Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD).
Results and safety
The study was stopped early (reason given: Sponsor decision to not initiate part 2 due to slow enrollment and competing trials.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Pande, M.D. study director
Incyte Corporation
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Itacitinib and docetaxel in people with NSCLC (Non-small Cell Lung Carcinoma), run by Incyte Corporation at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision to not initiate part 2 due to slow enrollment and competing trials.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Baseline through 21 days; the end of cycle 1.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.