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Lung CancerPhase 1/2NCT02917993

An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer

A Phase 1/2 study testing Itacitinib and Osimertinib in people with Lung Cancer, run by Incyte Corporation at 31 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and tolerability of itacitinib in combination with osimertinib in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Itacitinib and Osimertinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
31 sitesin 4 countries
Study dates
20 Dec 2016to 24 Dec 2025
Phase
Phase 1/2
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

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

31 sites in 4 countries.

31 sites in 4 countries

United States23 sites

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

    Austin, Texas, 78705

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

    Boca Raton, Florida, 33486

  • Dana-Farber Cancer Institute, 450 Brookline Avenue

    Boston, Massachusetts, 02215

  • Cleveland Clinic, 9500 Euclid Avenue, G Building

    Cleveland, Ohio, 44195

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

    Denver, Colorado, 80124

  • Henry Ford Health System, 2799 W Grand Blvd.

    Detroit, Michigan, 48202

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

    Detroit, Michigan, 48202

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

    Fairfax, Virginia, 22031

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

    Fountain Hill, Pennsylvania, 18015

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

    Houston, Texas, 77030

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

    La Jolla, California, 92093

  • West Virginia University Cancer Institute, 1 Medical Center Drive

    Morgantown, West Virginia, 26506

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

    New York, New York, 10016

  • Thomas Jefferson University, 111 S. 11th Street

    Philadelphia, Pennsylvania, 19107

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

    Portland, Oregon, 97213

  • Valley Hospital, 223 N Van Dien Avenue

    Ridgewood, New Jersey, 07450

  • Huntsman Cancer Institute, 2000 Circle of Hope Drive

    Salt Lake City, Utah, 84112

  • Texas Oncology - San Antonio Medical, 5206 Research Drive

    San Antonio, Texas, 78240

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

    San Francisco, California, 94115

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

    Stony Brook, New York, 11794

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

    Tyler, Texas, 75702

  • Georgetown University Hospital, 3800 Reservoir Rd, NW

    Washington D.C., District of Columbia, 20007

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

    Whittier, California, 90603

Other trials in United States

South Korea3 sites

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

    Seoul, Seocho-gu, 06591

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

    Seoul, Seodaemun-gu, 03722

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

    Seoul, Songpa-gu, 05505

Other trials in South Korea

Spain3 sites

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

    Barcelona, 08035

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

    Madrid, 28034

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

    Valencia, 46010

Other trials in Spain

Taiwan2 sites

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

    Taipei, Beitou District, 11217

  • National Taiwan University Hospital, 7 Zhongshan South Road

    Taipei, Zhongzheng District, 10002

Other trials in Taiwan

About this study

Official title: An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

The purpose of this study is to evaluate the safety and tolerability of itacitinib in combination with osimertinib in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Conditions
Lung Cancer
Being tested
Itacitinib, Osimertinib
Keywords
non-small cell lung cancer, locally advanced, metastatic, epidermal growth factor receptor (EGFR) inhibition, Janus kinase inhibition
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Inhibition, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ItacitinibDrug

    Also called INCB039110

    In Phase 1, itacitinib at a protocol-defined starting dose, with subsequent dose escalation based on protocol-specific criteria. In Phase 2, itacitinib at the recommended dose from Phase 1.

  • OsimertinibDrug

    Osimertinib 80 mg once daily (QD)

Study groups in NCT02917993
Study groupRoleWhat they receive
Itacitinib + osimertinibExperimentalNot described
Receives: Drug: Itacitinib; Drug: Osimertinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Frequency, severity, and duration of adverse events (AEs)

    Measured: From screening through 30-35 days after end of treatment, approximately 2 years.

  2. Phase 1: Number of subjects with dose-limiting toxicities (DLTs)

    Measured: Day 1 through Day 28

  3. Phase 2: Objective response rate (ORR) based on RECIST v1.1

    ORR defined as the percentage of subjects who have a confirmed best overall response of complete response (CR) or partial response (PR).

    Measured: Screening and 8-week intervals throughout the study, approximately 2 years.

Secondary outcomes (6)

  1. Phase 1 and Phase 2: Maximum plasma concentration (Cmax) of itacitinib and osimertinib when administered in combination

    Measured: Measured at protocol-defined study visits from Cycle 1 Day 1 through Cycle 1 Day 28.

  2. Phase 1 and Phase 2: Area under the plasma concentration-time curve (AUC) of Itacitinib and osimertinib when administered in combination

    Measured: Measured at protocol-defined study visits from Cycle 1 Day 1 through Cycle 1 Day 28.

  3. Phase 2: Depth of response (DpR) based on RECIST v1.1

    Defined as the percentage of maximal tumor shrinkage observed at the lowest point (nadir) compared with baseline.

    Measured: Screening and 8-week intervals throughout the study, approximately 2 years.

  4. Phase 2: Progression-free survival (PFS)

    Measured: Interval from the first day of study treatment until disease progression or death due to any cause, approximately 3 years.

  5. Phase 2: Overall survival (OS)

    Measured: Interval from the first day of study treatment until death due to any cause, approximately 3 years.

  6. Phase 2: Frequency, severity, and duration of AEs

    Measured: From screening through 30-35 days after end of treatment, approximately 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2016 (estimated)
  2. Study start20 Dec 2016
  3. Primary completion24 Dec 2025
  4. Study completion24 Dec 2025

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02917993
Sponsor's protocol ID
INCB 39110-207
Other IDs
2017-001750-34, 2017
Status last verified
Feb 2026
First submitted
26 Sep 2016
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Itacitinib and Osimertinib in people with Lung Cancer, run by Incyte Corporation at 31 sites in 4 countries.

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 7 inclusion and 10 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: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, South Korea, Spain, Taiwan. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Phase 1: Frequency, severity, and duration of adverse events (AEs) (time frame: From screening through 30-35 days after end of treatment, approximately 2 years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02917993.

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 9 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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