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New combo therapy targets tough lung cancer

NCT ID NCT02917993

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding itacitinib to the standard drug osimertinib is safe and effective for people with advanced non-small cell lung cancer that has a specific EGFR gene mutation. The trial involved 59 participants and was completed. The goal was to see if the combination could shrink tumors better than osimertinib alone, while also checking for 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 combined with osimertinib
What this could lead to
If successful, this combination could offer a new treatment option for people with a specific type of advanced lung cancer that has an EGFR mutation.
What could go wrong
This is an early-phase trial with only 59 participants, so results may not apply to everyone. Combining drugs can increase side effects, and the added benefit of itacitinib over osimertinib alone is not yet proven.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

59 people

The number who actually took part.

Started

Dec 2016

Finished

Dec 2025

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: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Inhibition, Psychological lung cancer lung neoplasm Neoplasm Metastasis non-small cell lung carcinoma

As listed by the trial registrant

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

Lung cancer

Contacts and locations

Locations

  • Antiga Guarderia-Servei d'Oncologia Hospital Vall d'Hebron. P.Vall Hebron 119-129

    Barcelona, 08035, Spain

  • Asan Medical Center Department of Oncology, 88, Olympic-ro 43-gil

    Seoul, Songpa-gu, 05505, South Korea

  • Cleveland Clinic, 9500 Euclid Avenue, G Building

    Cleveland, Ohio, 44195, United States

  • Dana-Farber Cancer Institute, 450 Brookline Avenue

    Boston, Massachusetts, 02215, United States

  • Earle A. Chiles Research Institute Providence Cancer Center, 4805 NE Glisan Street, 2N35

    Portland, Oregon, 97213, United States

  • Georgetown University Hospital, 3800 Reservoir Rd, NW

    Washington D.C., District of Columbia, 20007, United States

  • Henry Ford Health System, 2799 W Grand Blvd.

    Detroit, Michigan, 48202, United States

  • Hospital Clinico Universitario Valencia Avenida Blasco Ibáñez 17 -8º

    Valencia, 46010, Spain

  • Hospital Ramón y Cajal Ctra. Colmenar Viejo Km. 9,1 Planta (-)2 Dcha Oficina de Ensayos Clínicos Servicio de Oncología Médica

    Madrid, 28034, Spain

  • Huntsman Cancer Institute, 2000 Circle of Hope Drive

    Salt Lake City, Utah, 84112, United States

  • Innovative Clinical Research Institute, 15111 Whittier Blvd., Suite 216

    Whittier, California, 90603, United States

  • Karmanos Cancer Institute, 4100 John R. street mail Code HW04HO

    Detroit, Michigan, 48202, United States

  • Lynn Cancer Center, 701 NW 13th Street, Floor 2

    Boca Raton, Florida, 33486, United States

  • NYU Langone Medical Center, 160 East 34th Street, Floor 8

    New York, New York, 10016, United States

  • National Taiwan University Hospital, 7 Zhongshan South Road

    Taipei, Zhongzheng District, 10002, Taiwan

  • Rocky Mountain Cancer Center, 1800 Williams Street, Suite 200

    Denver, Colorado, 80124, United States

  • Severance Hospital, Yonsei University Health System 50-1 Yonsei-ro

    Seoul, Seodaemun-gu, 03722, South Korea

  • St. Luke's University Health Network, 701 Ostrum Street, Suite 403

    Fountain Hill, Pennsylvania, 18015, United States

  • Stony Brook University Medical Center, 3 Edmund D. Pellegrino Road

    Stony Brook, New York, 11794, United States

  • Taipei Veterans General Hospital, No.201 Sec. 2 Shipai Rd l

    Taipei, Beitou District, 11217, Taiwan

  • Texas Oncology - San Antonio Medical, 5206 Research Drive

    San Antonio, Texas, 78240, United States

  • Texas Oncology - South Austin, 901 West 38th Street, Suite 200

    Austin, Texas, 78705, United States

  • Texas Oncology-Tyler, 910 E Houston Street, Suite 100

    Tyler, Texas, 75702, United States

  • The catholic University of Korea, Seoul St. Mary's hospital, 222 Banpo-daero

    Seoul, Seocho-gu, 06591, South Korea

  • Thomas Jefferson University, 111 S. 11th Street

    Philadelphia, Pennsylvania, 19107, United States

  • US Oncology-Virginia Cancer Specialists, PC, 8503 Arlington Blvd., Suite 400

    Fairfax, Virginia, 22031, United States

  • University California San Francisco Thoracic Surgery and Oncology Clinic, 1600 Divisadero Street, Floor 4

    San Francisco, California, 94115, United States

  • University of California San Diego, 3855 Health Sciences Drive, Mc 0987

    La Jolla, California, 92093, United States

  • University of Texas -MD Anderson Cancer Center, 1515 Holcombe Blvd.

    Houston, Texas, 77030, United States

  • Valley Hospital, 223 N Van Dien Avenue

    Ridgewood, New Jersey, 07450, United States

  • West Virginia University Cancer Institute, 1 Medical Center Drive

    Morgantown, West Virginia, 26506, United States

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