ClinicalTrials.gg
CompletedNCT03322566Updated Jan 24, 2022Results posted

A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)

A Phase 2 interventional study of Pembrolizumab and Epacadostat in Lung Cancer, sponsored by Incyte Corporation. Completed at 94 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-24.

Primary conditionCarcinoma, Non-Small-Cell LungRegistry: Lung NeoplasmsReclassifiedWhy we changed it
Registry
Lung Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Carcinoma, Non-Small-Cell Lung
Why
  1. The study's title name Carcinoma, Non-Small-Cell Lung, a narrower term within Lung Neoplasms.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Incyte Corporation · Phase 2, Interventional, and Treatment

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 2
Study type
Interventional
Enrollment
233
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

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

Among 30 studies in Carcinoma, Non-Small-Cell Lung by Incyte Corporation — 1 open to participants now, 1 under way, none of them phase 3. Carcinoma, Non-Small-Cell Lung · Incyte Corporation.

Enrollment
3rd of 30
233 · median 53
Started
2018
with 4 others
Phase 2
9 of 30
none open now
Registered
14th of 30
by date

Among the 30 studies in Carcinoma, Non-Small-Cell Lung by Incyte Corporation, this one is the 3rd largest by enrollment, is one of 5 that started in 2018, is one of 9 in phase 2, and was the 14th 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

1 of the 30 studies in Carcinoma, Non-Small-Cell Lung by Incyte Corporation is open now, in 8 countries. Recruiting first, the newest first:

By country, each count listing its studies:

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.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 30 studies in Carcinoma, Non-Small-Cell Lung by Incyte Corporation, or all of them as a file.
02

Study summary

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC).

03

Conditions studied

  • Lung Cancer

Browse trials for

Keywords

  • Non-small cell lung cancer
  • programmed cell death 1 (PD-1) inhibitor
  • indoleamine 2
  • 3-dioxygenase 1 (IDO1) inhibitor
  • chemotherapy
04

In context

Carcinoma, Non-Small-Cell Lung Reclassified

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

This study's enrollment of 233 is above the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Incyte Corporation is the lead sponsor of 288 studies on the registry; 34 are open to participants now.

Of its 149 completed or terminated interventional studies of FDA-regulated products, 95 (64%) have results posted.

Compared within Carcinoma, Non-Small-Cell Lung, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lung Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

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

  • or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation
  • based on 1.1
  • of at least 3 months.
  • (ECOG) performance status of 0 or 1.
  • Adequate organ function per protocol-defined criteria.
  • Provide tumor tissue sample.

Exclusion criteria

Exclusion Criteria:

  • Known untreated central nervous system and/or carcinomatous meningitis
  • History of (non-infectious) pneumonitis that required systemic or current pneumonitis/interstitial lung disease.
  • Symptomatic ascites or pleural effusion.
  • Known history of an additional , except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
  • Active disease that has required systemic treatment in past 2 years.
  • Has had an allogeneic tissue/solid organ transplant.
  • Has a known history of (HIV) infection. HIV testing is not required unless mandated by the local health authority.
  • Has known history of or is positive for active (HBsAg reactive) or has active (HCV RNA). Note: Testing must be performed to determine eligibility.
  • History or presence of an abnormal (ECG) that, in the Investigator's opinion, is .
  • Use of protocol-defined prior/concomitant therapy.
Terms in these criteria, in plain language(14)

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.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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.

Metastases

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

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.

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.

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.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

06

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
233 participants (actual)

Study arms

  • Experimental
    Pembrolizumab + Chemotherapy + Epacadostat

    Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).

    Drug: Pembrolizumab · Drug: Epacadostat · Drug: Platinum-based chemotherapy

  • Experimental
    Pembrolizumab + Chemotherapy + Placebo

    Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).

    Drug: Pembrolizumab · Drug: Platinum-based chemotherapy · Drug: Placebo

  • Experimental
    Pembrolizumab + Epacadostat

    Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.

    Drug: Pembrolizumab · Drug: Epacadostat

Interventions

  • Pembrolizumab administered intravenously every 3 weeks.

    Also known as: MK-3475

  • Epacadostat administered orally twice daily.

    Also known as: INCB024360

  • DrugPlatinum-based chemotherapy

    Investigator selected one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin, depending on histology.

  • DrugPlacebo

    Matching placebo administered orally twice daily.

07

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

    ORR is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) based on blinded independent central review (BICR).

    Time frame: Assessed every 12 weeks up to 24 months

Secondary outcomes

  1. Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

    Defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.

    Time frame: Up to 24 months

  2. Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

    Defined as the time from randomization to death due to any cause.

    Time frame: Up to 24 months

  3. Duration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

    Defined as the time from the earliest date of qualifying response until earliest date of disease progression, per RECIST v1.1, or death from any cause, whichever comes first.

    Time frame: Up to 24 months

  4. Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Experiencing Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

    Time frame: Up to 25 months

  5. Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Discontinuing Study Drug Due to AEs

    An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of any study drug, whether or not considered related to the study drug.

    Time frame: Up to 25 months

08

Results

Posted Jan 29, 2020
Limitations and caveats
Data from the final analysis of KEYNOTE-715/ECHO-306 (data cutoff: 13-DEC-2018) indicated that the study did not meet the pre-specified endpoint of improvement in objective response rate (ORR).

Participant flow

Participants took part in the study at 65 investigative sites in 14 countries from 09 January 2018 to 13 December 2018.

Participant flow — Overall Study
MilestonePembrolizumab + Chemotherapy + EpacadostatPembrolizumab + Chemotherapy + PlaceboPembrolizumab + Epacadostat
Started918755
Completed464222
Not completed454533
Withdrew: Death343523
Withdrew: Physician decision672
Withdrew: Withdrawal by subject436
Withdrew: Lost to follow-up001
Withdrew: Study terminated by sponsor101

Outcome measures

PrimaryObjective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

ORR is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) based on blinded independent central review (BICR).

Time frame:
Assessed every 12 weeks up to 24 months
Reported as:
Number · percentage of participants
Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
percentage of participantsPembrolizumab + Chemotherapy + EpacadostatPembrolizumab + Chemotherapy + Placebo
Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo26.4 (17.7 to 36.7)44.8 (34.1 to 55.9)
Statistical analysis
  • Pembrolizumab + Chemotherapy + Epacadostat vs Pembrolizumab + Chemotherapy + Placebo · Stratified Miettinen and Nurminen method · p = 0.9948 (One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.) · Difference in percentages: -18.5 · 95% CI -32.0 to -4.3Stratified by PD-L1 TPS ( \<50% vs. \>=50% ) and predominant tumor histology (squamous vs non-squamous);because of small sample size, the strata 'TPS \>= 50 percent Non-squamous' and 'TPS \>= 50% Squamous' were combined into one stratum.
SecondaryProgression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

Defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.

Time frame:
Up to 24 months
Reported as:
Median · months
Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
monthsPembrolizumab + Chemotherapy + EpacadostatPembrolizumab + Chemotherapy + Placebo
Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo8.0 (4.2 to 10.2)8.2 (6.0 to NA)
Statistical analysis
  • Pembrolizumab + Chemotherapy + Epacadostat vs Pembrolizumab + Chemotherapy + Placebo · Regression, Cox · p = 0.94305 (One-sided p-value based on log-rank test stratified by TPS (\<50% vs \>=50%) and predominant histology (squamous vs non-squamous), because of small sample size, the strata 'TPS \>= 50% Non-squamous' and 'TPS \>= 50% Squamous' were combined into one.) · Hazard ratio (hr): 1.47 · 95% CI 0.91 to 2.36Efron's method of tie handling
SecondaryOverall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

Defined as the time from randomization to death due to any cause.

Time frame:
Up to 24 months
Reported as:
Median · months
Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
monthsPembrolizumab + Chemotherapy + EpacadostatPembrolizumab + Chemotherapy + Placebo
Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + PlaceboNA (NA to NA)NA (NA to NA)
Statistical analysis
  • Pembrolizumab + Chemotherapy + Epacadostat vs Pembrolizumab + Chemotherapy + Placebo · Regression, Cox · p = 0.96272 (One-sided p-value based on log-rank test stratified by PD-L1 TPS (\<50% vs \>=50%) and predominant tumor histology (squamous vs non-squamous), because of small sample size, the strata (\<50% vs \>=50%) were combined into one stratum.) · Hazard ratio (hr): 1.90 · 95% CI 0.93 to 3.90
SecondaryDuration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

Defined as the time from the earliest date of qualifying response until earliest date of disease progression, per RECIST v1.1, or death from any cause, whichever comes first.

Time frame:
Up to 24 months
Reported as:
Median · months
Duration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
monthsPembrolizumab + Chemotherapy + EpacadostatPembrolizumab + Chemotherapy + Placebo
Duration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + PlaceboNA (1.1 to 7.0)7.0 (1.2 to 8.0)
SecondarySafety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Experiencing Adverse Events (AEs)

An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Time frame:
Up to 25 months
Reported as:
Count of participants · Participants
Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Experiencing Adverse Events (AEs)
ParticipantsPembrolizumab + Chemotherapy + EpacadostatPembrolizumab + Chemotherapy + Placebo
Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Experiencing Adverse Events (AEs)8982
SecondarySafety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Discontinuing Study Drug Due to AEs

An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of any study drug, whether or not considered related to the study drug.

Time frame:
Up to 25 months
Reported as:
Count of participants · Participants
Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Discontinuing Study Drug Due to AEs
ParticipantsPembrolizumab + Chemotherapy + EpacadostatPembrolizumab + Chemotherapy + Placebo
Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Discontinuing Study Drug Due to AEs3735

Adverse events

Collected over Up to 25 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pembrolizumab + Chemotherapy + Epacadostat38/90 (42.2%)47/90 (52.2%)87/90 (96.7%)
Pembrolizumab + Chemotherapy + Placebo35/86 (40.7%)41/86 (47.7%)81/86 (94.2%)
Pembrolizumab + Epacadostat26/52 (50%)20/52 (38.5%)51/52 (98.1%)
Total99/228 (43.4%)108/228 (47.4%)219/228 (96.1%)
Most frequent serious events
Showing 10 of 113
Most frequent serious events
EventPembrolizumab + Chemotherapy + EpacadostatPembrolizumab + Chemotherapy + PlaceboPembrolizumab + EpacadostatTotal
Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)5/902/868/5215/228
PneumoniaInfections and infestations5/9012/864/5221/228
Febrile neutropeniaBlood and lymphatic system disorders5/900/860/525/228
DeathGeneral disorders0/900/862/522/228
Pleural effusionRespiratory, thoracic and mediastinal disorders2/901/862/525/228
PneumonitisRespiratory, thoracic and mediastinal disorders1/903/860/524/228
BronchitisInfections and infestations3/901/860/524/228
Lower respiratory tract infectionInfections and infestations3/901/860/524/228
SepsisInfections and infestations3/900/861/524/228
Atrial fibrillationCardiac disorders1/902/860/523/228
Most frequent other events
Showing 10 of 76
Most frequent other events
EventPembrolizumab + Chemotherapy + EpacadostatPembrolizumab + Chemotherapy + PlaceboPembrolizumab + EpacadostatTotal
AnaemiaBlood and lymphatic system disorders24/9037/868/5269/228
NauseaGastrointestinal disorders38/9037/8610/5285/228
FatigueGeneral disorders28/9025/8614/5267/228
ConstipationGastrointestinal disorders26/9023/868/5257/228
DiarrhoeaGastrointestinal disorders23/9023/8614/5260/228
RashSkin and subcutaneous tissue disorders22/9018/8610/5250/228
Decreased appetiteMetabolism and nutrition disorders19/9020/868/5247/228
CoughRespiratory, thoracic and mediastinal disorders10/9011/8612/5233/228
VomitingGastrointestinal disorders19/9011/866/5236/228
AstheniaGeneral disorders12/9018/866/5236/228

Baseline characteristics

Intent-to-treat (ITT) population included all participants who were randomized to study intervention.

Age, Continuous
Age, Continuous(years)Pembrolizumab + Chemotherapy + EpacadostatPembrolizumab + Chemotherapy + PlaceboPembrolizumab + EpacadostatTotal
Mean63.0 ± 11.763.6 ± 8.862.8 ± 8.463.2 ± 9.9
Sex: Female, Male
Sex: Female, Male(Participants)Pembrolizumab + Chemotherapy + EpacadostatPembrolizumab + Chemotherapy + PlaceboPembrolizumab + EpacadostatTotal
Female33301679
Male585739154
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Pembrolizumab + Chemotherapy + EpacadostatPembrolizumab + Chemotherapy + PlaceboPembrolizumab + EpacadostatTotal
Race — American Indian Or Alaska Native1001
Race — Asian1110223
Race — Black Or African American1102
Race — White787553206
Race — Missing0101
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Pembrolizumab + Chemotherapy + EpacadostatPembrolizumab + Chemotherapy + PlaceboPembrolizumab + EpacadostatTotal
Ethnicity — Hispanic or Latino3115
Ethnicity — Not Hispanic or Latino868552223
Ethnicity — Unknown2114
Ethnicity — Not Reported0011
09

Study locations

94 sites
  • Southern Cancer Center, PC
    Daphne, Alabama 36526, United States
  • Western Regional Medical Center, Inc.
    Goodyear, Arizona 85338, United States
  • Arizona Oncology Associates PC- HOPE
    Tucson, Arizona 85704, United States
  • Lynn Cancer Institute
    Boca Raton, Florida 33486, United States
  • Florida Cancer Specialists (South Region)
    Fort Myers, Florida 33901-8101, United States
  • Florida Cancer Specialists (North Region)
    Saint Petersburg, Florida 33705, United States
  • PPG-Oncology
    Fort Wayne, Indiana 46845, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • MMCORC
    Saint Louis Park, Minnesota 55416, United States
  • St. Vincent Healthcare Frontier Cancer Center
    Billings, Montana 59102, United States
  • New York Oncology Hematology P.C
    Albany, New York 12208, United States
  • Oncology Hematology Care, Inc.
    Cincinnati, Ohio 45242, United States
  • Southwestern Regional Medical Center, Inc.
    Tulsa, Oklahoma 74133, United States
  • St. Luke's Hospital - Anderson Campus
    Easton, Pennsylvania 18045, United States
  • Allegheny General Hospital
    Pittsburgh, Pennsylvania 15224, United States
  • Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
    Chattanooga, Tennessee 37404, United States
  • Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
    Nashville, Tennessee 37203, United States
  • Texas Oncology-Denton South
    Denton, Texas 76210, United States
  • Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care
    Blacksburg, Virginia 24060, United States
  • Emily Couric Clinical Cancer Center
    Charlottesville, Virginia 22908, United States
  • Seattle Cancer Care Alliance
    Seattle, Washington 98109, United States
  • MNCCI Port Macquarie Base Hospital
    Port Macquarie, New South Wales (Australia) 2444, Australia
  • Blacktown Hospital
    Blacktown, New South Wales 2148, Australia
  • Chris OBrien Lifehouse
    Camperdown, New South Wales 2050, Australia
  • The Crown Princess Mary Cancer Centre Westmead
    Westmead, New South Wales 2145, Australia
  • Southern Medical Day Care Centre
    Wollongong, New South Wales 2500, Australia
  • Cairns Base Hospital
    Cairns, Queensland 4870, Australia
  • BCCA-Cancer Centre of the Southern Interior
    Kelowna, British Columbia V1Y 5L3, Canada
  • Lions Gate Hospital
    North Vancouver, British Columbia V7L 2L7, Canada
  • CISSS de la Monteregie-Centre
    Greenfield Park, Quebec J4V 2H1, Canada
  • CSSS de Laval- Hopital de la Cite de la Sante
    Laval, Quebec H7M 3L9, Canada
  • CIUSSS Ouest de l'Ile - St-Mary's Hospital
    Montréal, Quebec H3T 1M5, Canada
  • CIUSSS du Nord-de-l'ILe-de-Montreal Hopital du Sacre-Coeur de Montreal
    Montréal, Quebec H4J 1C5, Canada
  • CIUSSS de la Mauricie-et-du-Centre-du-Quebec
    Trois-Rivières, Quebec G8Z 3R9, Canada
  • CHU de Quebec - Hotel-Dieu de Quebec
    Quebec, G1R 2J6, Canada
  • Zala Megyei Korhaz Pozvai Telephely
    Pozva, Zalaegerszeg 8900, Hungary
  • Orszagos Koranyi TBC es Pulmonologiai Intezet
    Budapest, 1121, Hungary
  • Veszprem Megyei Tudogyogyintezet
    Farkasgyepű, 8582, Hungary
  • Bekes Megyei Pandy Kalman Korhaz
    Gyula, 5700, Hungary
  • CRU Hungary Kft.
    Miskolc, 3529, Hungary
  • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
    Szolnok, 5004, Hungary
  • St Vincents University Hospital
    Dublin, Dublin 4, Ireland
  • Ha Emek Medical Center
    Afula, 1834111, Israel
  • Soroka Medical Center
    Be'er Sheva, 8457108, Israel
  • Rambam Medical Center
    Haifa, 3525408, Israel
  • Meir Medical Center
    Kfar Saba, 4428164, Israel
  • Rabin Medical Center
    Petah Tikva, 5262000, Israel
  • Chaim Sheba Medcal Center
    Ramat Gan, 52621, Israel
  • Centro Di Riferimento Oncologico
    Aviano, 33081, Italy
  • A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico
    Catania, 95123, Italy
  • Fondazione IRCCS Istituto Nazionale dei Tumori
    Milano, 20133, Italy
  • Istituto Europeo di Oncologia
    Milano, 20141, Italy
  • Ospedale San Gerardo - ASST Monza
    Monza, 20900, Italy
  • National Cancer Center
    Goyang-si, 10408, Korea, Republic of
  • Severance Hospital Yonsei University Health System
    Seoul, 03722, Korea, Republic of
  • Asan Medical Center
    Seoul, 05505, Korea, Republic of
  • Samsung Medical Center
    Seoul, 06351, Korea, Republic of
  • Medical Care Research S.A. de C.V.
    Mérida, Yucatan 97070, Mexico
  • Oaxaca Site Management Organization S.C.
    Oaxaca, 68000, Mexico
  • FAICIC Clinical Research
    Veracruz, 91900, Mexico
  • Belgorod Regional Oncology Dispensary
    Belgorod, 308010, Russian Federation
  • Udmurtia Republic Regional Clinical Oncology Dispensary
    Izhevsk, 426067, Russian Federation
  • Republican Clinical Oncology Dispensary of Tatarstan MoH
    Kazan, 420029, Russian Federation
  • Central Clinical Hospital with polyclinic
    Moscow, 121359, Russian Federation
  • Moscow Research Oncology Institute
    Moscow, 125284, Russian Federation
  • SBI of Stavropol region Pyatigorskiy Oncologic dispensary
    Pyatigorsk, 357502, Russian Federation
  • SBHI Leningrad Regional Clinical Hospital
    Saint Petersburg, 194291, Russian Federation
  • SBHI Samara Regional Clinical Oncology Dispensary
    Samara, 443031, Russian Federation
  • Oncological Dispensary #2 of Ministry of Health of Krasnodar region
    Sochi, 354057, Russian Federation
  • Tomsk Scientific Research Institute of Oncology
    Tomsk, 634028, Russian Federation
  • Hospital Universitario Insular de Gran Canaria
    Las Palmas De Gran Canaria, Gran Canaria 35016, Spain
  • Hospital Juan Ramón Jimenez
    Huelva, 21005, Spain
  • Institut Catala Oncologia de Bellvitge - ICO
    L'Hospitalet De Llobregat, 08980, Spain
  • Hospital Universitario La Paz
    Madrid, 28046, Spain
  • Hospital Universitario La Fe
    Valencia, 46026, Spain
  • Hospital Clinico Universitario Lozano Blesa
    Zaragoza, 50009, Spain
  • Chang Gung Medical Foundation, Kaohsiung Branch
    Kaohsiung, 833, Taiwan
  • China Medical University Hospital
    Taichung, 40447, Taiwan
  • National Cheng Kung University Hospital
    Tainan, 70457, Taiwan
  • National Taiwan University Hospital
    Taipei, 10048, Taiwan
  • Chang Gung Medical Foundation, Linkou Branch
    Taoyuan, 33305, Taiwan
  • Ege Universitesi Tip Fakultesi Hastanesi
    İzmir, Bornova 35100, Turkey
  • Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi
    Adana, 01120, Turkey
  • Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi
    Adana, 01330, Turkey
  • Hacettepe Universitesi Tip Fakultesi Hastanesi
    Ankara, 06100, Turkey
  • Uludag Universitesi Tip Fakultesi
    Bursa, 16059, Turkey
  • Pamukkale Unv. Tip Fak
    Denizli, 20070, Turkey
  • Istanbul Universitesi Cerrahpasa Tip Fakultesi
    Istanbul, 34098, Turkey
  • Samsun Medical Park Hastanesi
    Samsun, 55200, Turkey
  • Namık Kemal University Medical Faculty
    Tekirdağ, 59030, Turkey
  • Mount Vernon Cancer Centre
    Northwood, Middlesex HA6 2RN, United Kingdom
  • Western General Hospital
    Edinburgh, EH42XU, United Kingdom
  • North Middlesex Hospital
    London, N18 1QX, United Kingdom
  • Freeman Hospital Newcastle upon Tyne Foundation NHS Trust
    Newcastle Upon Tyne, NE7 7DN, United Kingdom
10

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

11

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Dec 2018, 11 months.

Results were first posted in Jan 2020, 1 year 1 month after primary completion.

Of 317 industry-sponsored phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 59. This study's 11 months is below that.

Counting every sponsor, half of 1,047 studies reached it within 48 months; a quarter within 30 and three quarters within 76.

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

Registered
Oct 24, 2017
First posted
Oct 26, 2017
StartActual
Jan 9, 2018
Primary completionActual
Dec 13, 2018
CompletionActual
Oct 16, 2020
Results first posted
Jan 29, 2020
Last update
Jan 24, 2022
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 Jan 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
12

Registry details

Key details

Study ID
NCT03322566
Lead sponsor
Incyte Corporation
Responsible party
Sponsor
First posted
Oct 26, 2017
Start date
Jan 9, 2018
Primary completion
Dec 13, 2018
Completion
Oct 16, 2020
Results posted
Jan 29, 2020
Last update
Jan 24, 2022

Study contacts

Lance Leopold, MD
study director · Incyte Corporation

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Epacadostat

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