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Lung cancer combo trial halted early – too few patients to draw conclusions

NCT ID NCT02257619

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 study tested whether adding itacitinib to standard chemotherapy (docetaxel) could help people with advanced non-small cell lung cancer live longer. The trial was stopped early after enrolling only 9 participants, so we cannot tell if the combination is safe or effective. The main goal was to find the right dose and check for serious side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
itacitinib and docetaxel
What this could lead to
If it worked, this combination might have offered a new treatment option for advanced lung cancer patients who had already tried one prior chemotherapy.
What could go wrong
The trial was terminated early with only 9 participants, so we have very little data. It is unclear if itacitinib adds any benefit or causes more side effects than docetaxel alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

9 people

The number who actually took part.

Started

Sep 2014

Finished

Apr 2016

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of NSCLC that is Stage IIIb, IV, or recurrent. 2. 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.) 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. 4. Life expectancy of ≥12 weeks. Exclusion Criteria: 1. Received prior treatment with docetaxel. 2. 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: 1. No evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases. 2. 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. 3. Peripheral neuropathy ≥ Grade 3. 4. 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. 5. Significant, concurrent, uncontrolled medical condition including but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease. 6. Unwilling to be transfused with blood components.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NSCLC (non-small cell lung carcinoma)

Contacts and locations

Locations

  • 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

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