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Clinical Trials List

Protocol NumberMK-3475-715/ECHO-306
NCT Number(ClinicalTrials.gov Identfier)NCT03322566

2017-10-15 - 2021-06-11

Phase II

Terminated5

ICD-10C34

Malignant neoplasm of bronchus and lung

A Randomized Phase 2 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    Merck Sharp & Dohme Corp.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Wu-Chou Su Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Te-Chun Hsia 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Taiwan National PI

楊政達

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

4 Stop recruiting

Audit

None

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Condition/Disease

Metastatic Non-Small Cell Lung Cancer

Objectives

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).

Test Drug

Keytruda / Epacadostat

Active Ingredient

epacadostat
Pembrolizumab

Dosage Form

Injection
Tablet

Dosage

100 mg/ 4mL
100

Endpoints

Primary Outcome Measures :
Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo [ Time Frame: Assessed after a minimum of 12 weeks of follow-up ( Data Cut Off of 13-Dec 18). ]
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).

Inclution Criteria

1. Have a histologically or cytologically confirmed diagnosis of stage IV (AJCC
version 8 or current version as applicable) NSCLC.
2. Have confirmation that EGFR, ALK, or ROS1 directed therapy is not indicated
as primary therapy (documentation of absence of tumor activating EGFR
mutations AND absence of ALK and ROS1 gene rearrangements OR presence of a KRAS mutation).
a. If participant’s tumor is known to have a predominantly squamous histology,
molecular testing for EGFR mutation and ALK and ROS1 translocations will
not be required, as this is not part of current diagnostic guidelines.
3. Have measurable disease based on RECIST 1.1 as determined by the local site.
a. Lesions situated in a previously irradiated area are considered measurable if
progression has been demonstrated in such lesions.
4. Be ≥18 years of age on the day of signing informed consent.
5. Have a life expectancy of at least 3 months.
6. Have an ECOG performance status of 0 or 1 within 7 days prior to the first dose
of study treatment but before randomization.
7. A male participant must agree to use contraception as detailed in Appendix 2 of
this protocol during the treatment period and for at least 120 days after the last
dose of pembrolizumab and epacadostat/matching placebo and up to 180 days
after last dose of chemotherapeutic agents.
8. A female participant is eligible to participate if she is not pregnant (see Protocol
Appendix 2), not breastfeeding, and at least one of the following conditions
applies:
a. Not a woman of childbearing potential (WOCBP) as defined in Protocol
Appendix 2
OR
b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 2
during the treatment period and for at least 120 days after the last dose of
pembrolizumab and epacadostat/matching placebo and up to 180 days after
last dose of chemotherapeutic agents.
9. The participant (or legally acceptable representative if applicable) provides
written informed consent for the study.
10. Have adequate organ function as indicated by the laboratory values in protcol
Table 1. Specimens must be collected and reviewed within 10 days prior to the
start of study treatment.
Table 1 Adequate Organ Function Laboratory Values
11. Have provided an evaluable archival tumor tissue sample or newly obtained
core or excisional biopsy of a tumor lesion (that was not previously irradiated)
for central PD-L1 testing. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.

Exclusion Criteria

1. Has known active central nervous system (CNS) metastases and/or
carcinomatous meningitis. Participants with previously treated brain metastases
may participate provided they are radiologically stable (without evidence of
progression by imaging for at least 4 weeks prior to the first dose of study
treatment), clinically stable, and have not required steroids for at least 14 days
before first dose of study treatment.
2. Has a history of (non-infectious) pneumonitis that required systemic steroids or
current pneumonitis/interstitial lung disease.
3. Has symptomatic ascites or pleural effusion. A participant who is clinically
stable following treatment for these conditions (including therapeutic thoraco- or
paracentesis) is eligible.
4. Has a known history of an additional malignancy, except if the participant has
undergone potentially curative therapy with no evidence of that disease
recurrence for 5 years since initiation of that therapy.
a. Note: The time requirement for no evidence of disease for 5 years does
not apply to the NSCLC for which a participant is enrolled in the study.
The time requirement also does not apply to participants who underwent
successful definitive resection of basal cell carcinoma of the skin,
superficial bladder cancer, squamous cell carcinoma of the skin, in situ
cervical cancer, or other in situ cancers.
5. Has an active autoimmune disease that has required systemic treatment in past 2
years (ie, with use of disease modifying agents, corticosteroids, or
immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency, etc.) is allowed.
6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid
therapy (doses exceeding 10 mg daily of prednisone equivalent) or any other
form of immunosuppressive therapy within 7 days prior the first dose of study
treatment.
7. Has had an allogeneic tissue/solid organ transplant.
8. Has a known history of human immunodeficiency virus (HIV) infection. HIV
testing is not required unless mandated by the local health authority.
9. Has known history of or is positive for active Hepatitis B (HBsAg reactive) or
has active Hepatitis C (HCV RNA). Note: Testing must be performed to
determine eligibility.
a. HBV DNA must be undetectable and HBsAg negative at screening visit.
b. Hepatitis C antibody testing is allowed for screening purposes in
countries where HCV RNA is not part of SOC. In these cases, HCV
antibody positive participants will be excluded.
c. Participants who have had definitive treatment for HCV are permitted if
HCV RNA is undetectable at screening.
10. Has a history of a gastrointestinal condition or procedure that in the opinion of
the Investigator may affect oral drug absorption.
11. Has a history or presence of an abnormal electrocardiogram (ECG) that, in the
Investigator's opinion, is clinically meaningful. Screening QTc interval >480
msec is excluded. In the event that a single QTc is >480 msec, the participant
may enroll if the average QTc for 3 ECGs is <480 msec.
12. Has clinically significant cardiac disease, including unstable angina, acute
myocardial infarction within 6 months from Day 1 of study drug administration,
or New York Heart Association Class III or IV congestive heart failure.
Medically controlled arrhythmia stable on medication is permitted.
13. Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
14. Has an active infection requiring systemic therapy.
15. Has known psychiatric or substance abuse disorders that would interfere with the
participant’s cooperation for the requirements of the study.
16. Previously had a severe hypersensitivity reaction to treatment with a monoclonal
antibody or has a known sensitivity to any component of epacadostat,
pembrolizumab, or as applicable, carboplatin, cisplatin, paclitaxel, or
pemetrexed.
17. WOCBP who has a positive urine pregnancy test within 72 hours before the first
dose of study treatment. If the urine test is positive or cannot be confirmed as
negative, a serum pregnancy test will be required.
a. Note: In the event that 72 hours have elapsed between the screening
pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for
participant to start receiving study treatment.
18. Is pregnant or breastfeeding or expecting to conceive or father children within
the projected duration of the study, starting with the screening visit through 120
days after the last dose of pembrolizumab and epacadostat/matching placebo and
up to 180 days after last dose of chemotherapeutic agents.
19. Has received prior systemic chemotherapy or other targeted or biological
anti-neoplastic therapy for their metastatic NSCLC.
a. Note: Prior treatment with chemotherapy and/or radiation as part of
neoadjuvant/adjuvant therapy is allowed as long as therapy was
completed at least 6 months prior to the diagnosis of metastatic NSCLC.
20. Has received prior treatment with pembrolizumab or any other anti-PD-1,
anti-PD-L1, anti-PD-L2 agent, with epacadostat or any anti-IDO1 agent, or with
an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg,
CTLA-4, OX-40, CD137, GITR).
21. Has received radiotherapy within 14 days before the first dose of study treatment
or received lung radiation therapy of >30 Gy within 6 months before the first
dose of study treatment.
22. Is receiving systemic steroid therapy ≤7 days prior to the first dose of study
treatment or receiving any other form of immunosuppressive medication.
23. Has received a live vaccine within 30 days prior to the first dose of study
treatment.
24. Has any history of Serotonin Syndrome after receiving serotonergic drugs.
25. Has received therapy with an MAOI, melatonin supplement, or UGT1A9
inhibitor within 21 days prior to starting treatment, or anticipates requiring one
of these prohibited medications during the treatment phase.
26. Is currently participating and receiving study therapy or has participated in a
study of an investigational agent and received study therapy or used an
investigational device within 4 weeks of the first dose of study treatment.
27. Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the study, interfere with the
participant's ability to participate for the full duration of the study, or is not in the
best interest of the participant to participate, in the opinion of the treating
Investigator.

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    148 participants

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