A Phase 2 interventional study of Pembrolizumab and Epacadostat in Lung Cancer, sponsored by Incyte Corporation. Completed at 101 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Incyte Corporation · Phase 2, Interventional, and Treatment
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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.
Among the 30 studies in Carcinoma, Non-Small-Cell Lung by Incyte Corporation, this one is the 4th largest by enrollment, is one of 6 that started in 2017, is one of 9 in phase 2, and was the 14th registered.
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 →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:
Incyte Corporation · Sites in United States, Australia, Belgium and 5 more countries
Ages 18+
By country, each count listing its studies:
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.
30 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 18 · Phase 2 20 · Phase 3 3
First in 2014; this study’s year is marked. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 154 is above the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 53 across the 30 interventional studies. Of the 26 that completed or were terminated, 19 (73%) have results posted.
This tab as a report to print or save as PDF → With an account.
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.
1 of the studies in Carcinoma, Non-Small-Cell Lung by Incyte Corporation that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06179160Incyte CorporationA Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation | 2027-01-01 |
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Among the 30 studies in Carcinoma, Non-Small-Cell Lung by Incyte Corporation, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell death ligand 1 (PD-L1).
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 154 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 →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 →
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
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 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 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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
Drug: Pembrolizumab · Drug: Epacadostat
Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
Drug: Pembrolizumab · Drug: Placebo
Pembrolizumab administered intravenously every 3 weeks.
Also known as: MK-3475
Epacadostat administered orally twice daily.
Also known as: INCB024360
Matching placebo administered orally twice daily.
Objective Response Rate (ORR) of Pembrolizumab Plus Epacadostat Versus Pembrolizumab Plus Placebo
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 based on blinded independent central review (BICR).
Time frame: Up to approximately 6 months
Progression-free Survival (PFS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
PFS is defined as the time from randomization to the first documented progressive disease per RECIST v1.1 based on BICR or death due to any cause, whichever occurs first.
Time frame: Up to approximately 36 months
Overall Survival (OS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 36 months
Duration of Response (DOR) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
DOR is 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 approximately 36 months
Number of Participants With Adverse Events (AEs)
AE is defined as any untoward medical occurrence in a patient 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 37 months
Number of Participants Who Discontinued Study Drug Due to AEs
AE is defined as any untoward medical occurrence in a patient 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 37 months
A total of 154 participants were randomized in 1:1 to either combination (Pembrolizumab+Epacadostat) and control (Pembrolizumab+Placebo) groups. As of Amendment 05, study design was changed to unblinded, open-label, and single-arm (epacadostat and placebo were removed).
| Milestone | Pembrolizumab + Epacadostat | Pembrolizumab + Placebo |
|---|---|---|
| Started | 77 | 77 |
| Number of subjects received treatment (actual treatment) (asat) | 75 | 77 |
| Completed | 46 | 40 |
| Not completed | 31 | 37 |
| Withdrew: Death | 21 | 28 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Physician decision | 7 | 6 |
| Withdrew: Withdrawal by subject | 3 | 1 |
| Withdrew: Study terminated by sponsor | 0 | 1 |
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 based on blinded independent central review (BICR).
| percentage of participants | Pembrolizumab + Epacadostat | Pembrolizumab + Placebo |
|---|---|---|
| Objective Response Rate (ORR) of Pembrolizumab Plus Epacadostat Versus Pembrolizumab Plus Placebo | 32.5 (22.2 to 44.1) | 39.0 (28.0 to 50.8) |
PFS is defined as the time from randomization to the first documented progressive disease per RECIST v1.1 based on BICR or death due to any cause, whichever occurs first.
| months | Pembrolizumab + Epacadostat | Pembrolizumab + Placebo |
|---|---|---|
| Progression-free Survival (PFS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo | 6.7 (4.3 to 8.2) | 6.2 (4.3 to NA) |
OS is defined as the time from randomization to death due to any cause.
| Months | Pembrolizumab + Epacodostat | Pembrolizumab + Placebo |
|---|---|---|
| Overall Survival (OS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo | NA (NA to NA) | NA (NA to NA) |
DOR is 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.
| Months | Pembrolizumab + Epacodostat | Pembrolizumab + Placebo |
|---|---|---|
| Duration of Response (DOR) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo | 6.2 (1.9 to 6.5) | NA (1.9 to 8.6) |
AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
| Participants | Pembrolizumab + Epacodostat | Pembrolizumab + Placebo |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 72 | 72 |
AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
| Participants | Pembrolizumab + Epacodostat | Pembrolizumab + Placebo |
|---|---|---|
| Number of Participants Who Discontinued Study Drug Due to AEs | 15 | 12 |
Collected over Up to 37 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab + Epacadostat | 23/75 (30.7%) | 36/75 (48%) | 69/75 (92%) |
| Pembrolizumab + Placebo | 29/77 (37.7%) | 35/77 (45.5%) | 67/77 (87%) |
| Total | 52/152 (34.2%) | 71/152 (46.7%) | 136/152 (89.5%) |
| Event | Pembrolizumab + Epacadostat | Pembrolizumab + Placebo | Total |
|---|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 6/75 | 8/77 | 14/152 |
| PneumoniaInfections and infestations | 6/75 | 7/77 | 13/152 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 4/75 | 2/77 | 6/152 |
| AnaemiaBlood and lymphatic system disorders | 2/75 | 0/77 | 2/152 |
| AtelectasisRespiratory, thoracic and mediastinal disorders | 2/75 | 0/77 | 2/152 |
| HypokalaemiaMetabolism and nutrition disorders | 0/75 | 2/77 | 2/152 |
| HypotensionVascular disorders | 0/75 | 2/77 | 2/152 |
| Back painMusculoskeletal and connective tissue disorders | 1/75 | 0/77 | 1/152 |
| Cholangitis sclerosingHepatobiliary disorders | 1/75 | 0/77 | 1/152 |
| ColitisGastrointestinal disorders | 1/75 | 0/77 | 1/152 |
| Event | Pembrolizumab + Epacadostat | Pembrolizumab + Placebo | Total |
|---|---|---|---|
| ConstipationGastrointestinal disorders | 20/75 | 18/77 | 38/152 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 17/75 | 10/77 | 27/152 |
| Decreased appetiteMetabolism and nutrition disorders | 17/75 | 10/77 | 27/152 |
| DiarrhoeaGastrointestinal disorders | 16/75 | 17/77 | 33/152 |
| PruritusSkin and subcutaneous tissue disorders | 16/75 | 16/77 | 32/152 |
| FatigueGeneral disorders | 9/75 | 16/77 | 25/152 |
| RashSkin and subcutaneous tissue disorders | 15/75 | 11/77 | 26/152 |
| NauseaGastrointestinal disorders | 14/75 | 8/77 | 22/152 |
| HeadacheNervous system disorders | 13/75 | 4/77 | 17/152 |
| Back painMusculoskeletal and connective tissue disorders | 10/75 | 8/77 | 18/152 |
Intent-to-treat (ITT) population consisted of all randomized participants.
| Age, Continuous(years) | Pembrolizumab + Epacadostat | Pembrolizumab + Placebo | Total |
|---|---|---|---|
| Mean | 63.7 ± 9.5 | 66.9 ± 10.1 | 65.3 ± 9.9 |
| Sex: Female, Male(Participants) | Pembrolizumab + Epacadostat | Pembrolizumab + Placebo | Total |
|---|---|---|---|
| Female | 24 | 18 | 42 |
| Male | 53 | 59 | 112 |
| Race/Ethnicity, Customized(Participants) | Pembrolizumab + Epacadostat | Pembrolizumab + Placebo | Total |
|---|---|---|---|
| Asian | 25 | 23 | 48 |
| White | 52 | 54 | 106 |
| Race/Ethnicity, Customized(Participants) | Pembrolizumab + Epacadostat | Pembrolizumab + Placebo | Total |
|---|---|---|---|
| Not Hispanic Or Latino — Hispanic Or Latino | 7 | 4 | 11 |
| Not Hispanic Or Latino — Not Hispanic Or Latino | 66 | 73 | 139 |
| Not Hispanic Or Latino — Not Reported | 3 | 0 | 3 |
| Not Hispanic Or Latino — Unknown | 1 | 0 | 1 |
Showing the first 100 of 101 sites across 18 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Jan 2019, 12 months.
Results were first posted in Feb 2020, 1 year 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 12 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.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Epacadostat
Carcinoma, Non-Small-Cell Lung →