ClinicalTrials.gg
TerminatedNCT03425006Updated Sep 13, 2023Results posted

Pembrolizumab and Itacitinib (INCB039110) for Non-Small Cell Lung Cancer

A Phase 2 interventional study of Itacitinib and Pembrolizumab in Non Small Cell Lung Cancer, sponsored by University of Pennsylvania. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by University of Pennsylvania · Phase 2, Interventional, and Treatment

Why this study was terminated
Administrative reasons

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Phase
Phase 2
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 3,366 studies in Carcinoma, Non-Small-Cell Lung with a site in United States — 518 open to participants now, 892 under way, 142 of them phase 3. Carcinoma, Non-Small-Cell Lung · United States.

Enrollment
2,218th of 2,993
23 · median 56
Started
2018
with 160 others
Phase 2
1,078 of 3,366
119 open now
Registered
1,980th of 3,366
by date

Among the 3,366 studies in Carcinoma, Non-Small-Cell Lung with a site in United States, this one is the 2,218th largest by enrollment of the 2,993 interventional ones that give a count, is one of 161 that started in 2018, is one of 1,078 in phase 2, and was the 1,980th registered.

Carcinoma, Non-Small-Cell Lung

7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

518 of the 3,366 studies in Carcinoma, Non-Small-Cell Lung with a site in United States are open now. Recruiting first, the newest first:

513 more — sign in →

All 518 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

This is a single center, single arm phase 2 study to establish the safety and efficacy of itacitinib (also known as INCB039110) administered in combination with pembrolizumab in patients with metastatic PD-L1 positive non-small cell lung cancer (NSCLC).

03

Conditions studied

  • Non Small Cell Lung Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. Stage IV or non-small cell lung cancer (NSCLC)
    1. Provide written for the trial.
    1. Patients ≥ 18 years of age
    1. Tumor ≥ 50% as assessed by the PD-L1 IHC 22C3 pharmDx assay (Dako North America).
    1. Subject must have adequate tumor burden at a safely accessible site for . NOTE: If sites chosen for biopsy were previously irradiated, there must be evidence of tumor growth/viable tumor as assessed by the investigator.
    1. At least one according to (RECIST) v1.1
    1. performance status 0 or 1
    1. Adequate Organ Function Laboratory Values: (ANC) ≥1,250/mcL; ≥100,000/mcL; ≥9 g/dL or ≥5.6 mmol/L; Serum creatinine ≤1.5 X (ULN) OR Measured or calculated ( can also be used in place of creatinine or CrCl) ≥50 mL/min for subject with creatinine levels > 1.5 X institutional ULN; Serum total ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN; (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
    1. Subjects of must agree to use acceptable methods.

Exclusion criteria

Exclusion Criteria:

    1. Sensitizing mutations in Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) or ROS1 proto-oncogene receptor tyrosine kinase (ROS1) translocations
    1. Currently participating in or has participated in a study of an agent or anticipated use of an investigational device within 4 weeks of the first dose of study treatment.
    1. Untreated symptomatic central nervous system (CNS) and/or carcinomatous meningitis.
    1. Received prior systemic cytotoxic chemotherapy, biologic therapy, targeted therapy or immunotherapy for incurable (metastatic) NSCLC.
    1. Diagnosis of immunodeficiencywithin 7 days prior to eligibility confirmation by the physician-investigator.
    1. Prior monoclonal antibodies used for the treatment of NSCLC within 4 weeks prior to eligibility confirmation by the physician-investigator, or individuals who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
    1. Known additional that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-invasive bladder tumors, or in situ cervical cancer
      1. Active disease requiring systemic treatment within the past 3 months prior to eligibility confirmation by the physician-investigator. Subjects that require intermittent use of -containing bronchodilators or local steroid injections or topical steroid medications are not excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome are not excluded from the study.
    1. Interstitial lung disease or history of pneumonitis that has required oral or IV steroids
    1. Active infection requiring systemic therapy with IV antibiotics
    1. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
    1. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    1. Pregnant or breastfeeding women
    1. Prior therapy with an , anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4).
    1. Known history of (HIV) (HIV 1/2 antibodies).
    1. Known active (e.g., HBsAg positive or HBV DNA detectable) or (e.g., HCV RNA [qualitative] is detected).
    1. Anticipated receipt of any within 30 days prior to the first dose of trial treatment.

Note: For the purposes of determining eligibility above, enrollment is defined as the date of subject consent.

Terms in these criteria, in plain language(26)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Itacitinib and Pembrolizumab

    Drug: Itacitinib · Biological: Pembrolizumab

Interventions

  • a JAK 1 selective small molecule inhibitor

    Also known as: INCB039110

  • BiologicalPembrolizumab

    a highly selective humanized monoclonal antibody (mAb)

06

What researchers measure

Primary outcomes

  1. Number of Subjects With a Response at 12 Weeks According to RECIST 1.1 for the Combination of Pembrolizumab and Itacitinib Among Patients With Previously Untreated, PD-L1 Positive Metastatic NSCLC.

    Responses will be compared subject's baseline assessment and historical controls using pembrolizumab monotherapy.

    Time frame: 12 weeks

  2. Number of Subjects With Toxicities (CTCAE v5.0 Scoring) of Pembrolizumab and Itacitinib in Patients With Previously Untreated, PD-L1 Positive Metastatic NSCLC

    Number of subjects treated with the combination.

    Time frame: 16 weeks

Secondary outcomes

  1. Number of Participants Who Had a Progression Free Survival (PFS) Treated With Pembrolizumab and Itacitinib.

    Number of participants who remained progression free at week 12

    Time frame: 12 weeks

  2. Number of Participants Treated With Pembrolizumab and Itacitinib, Who Had a Minimum Duration of Response (DOR) of 12 Weeks.

    Time frame: 12 weeks

  3. Overall Survival (OS) for Subjects Treated With Pembrolizumab and Itacitinib.

    Number of subjects treated with pembrolizumab and itacitinib that survived to week 16.

    Time frame: 16 weeks

07

Results

Posted Sep 13, 2023

Participant flow

Participant flow — Overall Study
MilestoneItacitinib and Pembrolizumab
Started23
Completed20
Not completed3
Withdrew: Withdrawal by subject1
Withdrew: Physician decision1
Withdrew: Death1

Outcome measures

PrimaryNumber of Subjects With a Response at 12 Weeks According to RECIST 1.1 for the Combination of Pembrolizumab and Itacitinib Among Patients With Previously Untreated, PD-L1 Positive Metastatic NSCLC.

Responses will be compared subject's baseline assessment and historical controls using pembrolizumab monotherapy.

Time frame:
12 weeks
Reported as:
Count of participants · Participants
Number of Subjects With a Response at 12 Weeks According to RECIST 1.1 for the Combination of Pembrolizumab and Itacitinib Among Patients With Previously Untreated, PD-L1 Positive Metastatic NSCLC.
ParticipantsItacitinib and Pembrolizumab
Number of Subjects With a Response at 12 Weeks According to RECIST 1.1 for the Combination of Pembrolizumab and Itacitinib Among Patients With Previously Untreated, PD-L1 Positive Metastatic NSCLC.13
PrimaryNumber of Subjects With Toxicities (CTCAE v5.0 Scoring) of Pembrolizumab and Itacitinib in Patients With Previously Untreated, PD-L1 Positive Metastatic NSCLC

Number of subjects treated with the combination.

Time frame:
16 weeks
Reported as:
Count of participants · Participants
Number of Subjects With Toxicities (CTCAE v5.0 Scoring) of Pembrolizumab and Itacitinib in Patients With Previously Untreated, PD-L1 Positive Metastatic NSCLC
ParticipantsItacitinib and Pembrolizumab
Number of Subjects With Toxicities (CTCAE v5.0 Scoring) of Pembrolizumab and Itacitinib in Patients With Previously Untreated, PD-L1 Positive Metastatic NSCLC20
SecondaryNumber of Participants Who Had a Progression Free Survival (PFS) Treated With Pembrolizumab and Itacitinib.

Number of participants who remained progression free at week 12

Time frame:
12 weeks
Reported as:
Count of participants · Participants
Number of Participants Who Had a Progression Free Survival (PFS) Treated With Pembrolizumab and Itacitinib.
ParticipantsItacitinib and Pembrolizumab
Number of Participants Who Had a Progression Free Survival (PFS) Treated With Pembrolizumab and Itacitinib.20
SecondaryNumber of Participants Treated With Pembrolizumab and Itacitinib, Who Had a Minimum Duration of Response (DOR) of 12 Weeks.
Time frame:
12 weeks
Reported as:
Count of participants · Participants
Number of Participants Treated With Pembrolizumab and Itacitinib, Who Had a Minimum Duration of Response (DOR) of 12 Weeks.
ParticipantsItacitinib and Pembrolizumab
Number of Participants Treated With Pembrolizumab and Itacitinib, Who Had a Minimum Duration of Response (DOR) of 12 Weeks.13
SecondaryOverall Survival (OS) for Subjects Treated With Pembrolizumab and Itacitinib.

Number of subjects treated with pembrolizumab and itacitinib that survived to week 16.

Time frame:
16 weeks
Reported as:
Count of participants · Participants
Overall Survival (OS) for Subjects Treated With Pembrolizumab and Itacitinib.
ParticipantsItacitinib and Pembrolizumab
Overall Survival (OS) for Subjects Treated With Pembrolizumab and Itacitinib.23

Adverse events

Collected over 16 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Itacitinib and Pembrolizumab1/23 (4.3%)6/23 (26.1%)22/23 (95.7%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventItacitinib and Pembrolizumab
Myocardial infarctionCardiac disorders1/23
NauseaGastrointestinal disorders1/23
Stomach painGastrointestinal disorders1/23
Lung infectionInfections and infestations1/23
FractureInjury, poisoning and procedural complications1/23
AnorexiaMetabolism and nutrition disorders1/23
HypoglycemiaMetabolism and nutrition disorders1/23
Myasthenia gravisNervous system disorders1/23
Nervous system disorders - OtherNervous system disorders1/23
SeizureNervous system disorders1/23
Most frequent other events
Showing 10 of 38
Most frequent other events
EventItacitinib and Pembrolizumab
FatigueGeneral disorders8/23
DiarrheaGastrointestinal disorders7/23
CoughRespiratory, thoracic and mediastinal disorders7/23
NauseaGastrointestinal disorders6/23
Creatinine increasedInvestigations5/23
HeadacheNervous system disorders5/23
Weight gainInvestigations4/23
HyponatremiaMetabolism and nutrition disorders4/23
Back painMusculoskeletal and connective tissue disorders4/23
MyalgiaMusculoskeletal and connective tissue disorders4/23

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Itacitinib and Pembrolizumab
<=18 years0
Between 18 and 65 years14
>=65 years9
Sex: Female, Male
Sex: Female, Male(Participants)Itacitinib and Pembrolizumab
Female13
Male10
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Itacitinib and Pembrolizumab
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American3
White18
More than one race0
Unknown or Not Reported2
08

Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2018 to primary completion in Jun 2021, 35 months.

Results were first posted in Sep 2023, 2 years 2 months after primary completion. A results delay was requested in May 2022.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2018
First posted
Feb 7, 2018
StartActual
Jun 18, 2018
Primary completionActual
Jun 17, 2021
CompletionActual
Oct 11, 2021
Results delay requested
May 24, 2022
Results first posted
Sep 13, 2023
Last update
Sep 13, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03425006
Responsible party
Sponsor
First posted
Feb 7, 2018
Start date
Jun 18, 2018
Primary completion
Jun 17, 2021
Completion
Oct 11, 2021
Results posted
Sep 13, 2023
Last update
Sep 13, 2023

Study contacts

Corey Langer, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Itacitinib

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