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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)

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Epacadostat
Platinum-based chemotherapy
Placebo
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Non-small cell lung cancer, programmed cell death 1 (PD-1) inhibitor, indoleamine 2, 3-dioxygenase 1 (IDO1) inhibitor, chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Known untreated central nervous system metastases and/or carcinomatous meningitis
  • History of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
  • Symptomatic ascites or pleural effusion.
  • 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.
  • Active autoimmune disease that has required systemic treatment in past 2 years.
  • Has had an allogeneic tissue/solid organ transplant.
  • Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
  • 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.
  • History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
  • Use of protocol-defined prior/concomitant therapy.

Sites / Locations

  • Southern Cancer Center, PC
  • Western Regional Medical Center, Inc.
  • Arizona Oncology Associates PC- HOPE
  • Lynn Cancer Institute
  • Florida Cancer Specialists (South Region)
  • Florida Cancer Specialists (North Region)
  • PPG-Oncology
  • University of Michigan
  • MMCORC
  • St. Vincent Healthcare Frontier Cancer Center
  • New York Oncology Hematology P.C
  • Oncology Hematology Care, Inc.
  • Southwestern Regional Medical Center, Inc.
  • St. Luke's Hospital - Anderson Campus
  • Allegheny General Hospital
  • Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
  • Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
  • Texas Oncology-Denton South
  • Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care
  • Emily Couric Clinical Cancer Center
  • Seattle Cancer Care Alliance
  • MNCCI Port Macquarie Base Hospital
  • Blacktown Hospital
  • Chris OBrien Lifehouse
  • The Crown Princess Mary Cancer Centre Westmead
  • Southern Medical Day Care Centre
  • Cairns Base Hospital
  • BCCA-Cancer Centre of the Southern Interior
  • Lions Gate Hospital
  • CISSS de la Monteregie-Centre
  • CSSS de Laval- Hopital de la Cite de la Sante
  • CIUSSS Ouest de l'Ile - St-Mary's Hospital
  • CIUSSS du Nord-de-l'ILe-de-Montreal Hopital du Sacre-Coeur de Montreal
  • CIUSSS de la Mauricie-et-du-Centre-du-Quebec
  • CHU de Quebec - Hotel-Dieu de Quebec
  • Zala Megyei Korhaz Pozvai Telephely
  • Orszagos Koranyi TBC es Pulmonologiai Intezet
  • Veszprem Megyei Tudogyogyintezet
  • Bekes Megyei Pandy Kalman Korhaz
  • CRU Hungary Kft.
  • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
  • St Vincents University Hospital
  • Ha Emek Medical Center
  • Soroka Medical Center
  • Rambam Medical Center
  • Meir Medical Center
  • Rabin Medical Center
  • Chaim Sheba Medcal Center
  • Centro Di Riferimento Oncologico
  • A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Istituto Europeo di Oncologia
  • Ospedale San Gerardo - ASST Monza
  • National Cancer Center
  • Severance Hospital Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Medical Care Research S.A. de C.V.
  • Oaxaca Site Management Organization S.C.
  • FAICIC Clinical Research
  • Belgorod Regional Oncology Dispensary
  • Udmurtia Republic Regional Clinical Oncology Dispensary
  • Republican Clinical Oncology Dispensary of Tatarstan MoH
  • Central Clinical Hospital with polyclinic
  • Moscow Research Oncology Institute
  • SBI of Stavropol region Pyatigorskiy Oncologic dispensary
  • SBHI Leningrad Regional Clinical Hospital
  • SBHI Samara Regional Clinical Oncology Dispensary
  • Oncological Dispensary #2 of Ministry of Health of Krasnodar region
  • Tomsk Scientific Research Institute of Oncology
  • Hospital Universitario Insular de Gran Canaria
  • Hospital Juan Ramón Jimenez
  • Institut Catala Oncologia de Bellvitge - ICO
  • Hospital Universitario La Paz
  • Hospital Universitario La Fe
  • Hospital Clinico Universitario Lozano Blesa
  • Chang Gung Medical Foundation, Kaohsiung Branch
  • China Medical University Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Chang Gung Medical Foundation, Linkou Branch
  • Ege Universitesi Tip Fakultesi Hastanesi
  • Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi
  • Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi
  • Hacettepe Universitesi Tip Fakultesi Hastanesi
  • Uludag Universitesi Tip Fakultesi
  • Pamukkale Unv. Tip Fak
  • Istanbul Universitesi Cerrahpasa Tip Fakultesi
  • Samsun Medical Park Hastanesi
  • Namık Kemal University Medical Faculty
  • Mount Vernon Cancer Centre
  • Western General Hospital
  • North Middlesex Hospital
  • Freeman Hospital Newcastle upon Tyne Foundation NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Pembrolizumab + Chemotherapy + Epacadostat

Pembrolizumab + Chemotherapy + Placebo

Pembrolizumab + Epacadostat

Arm Description

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).

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).

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Defined as the time from randomization to death due to any cause.
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.
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.
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.

Full Information

First Posted
October 24, 2017
Last Updated
January 19, 2022
Sponsor
Incyte Corporation
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03322566
Brief Title
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)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
December 13, 2018 (Actual)
Study Completion Date
October 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Non-small cell lung cancer, programmed cell death 1 (PD-1) inhibitor, indoleamine 2, 3-dioxygenase 1 (IDO1) inhibitor, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
233 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab + Chemotherapy + Epacadostat
Arm Type
Experimental
Arm Description
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).
Arm Title
Pembrolizumab + Chemotherapy + Placebo
Arm Type
Experimental
Arm Description
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).
Arm Title
Pembrolizumab + Epacadostat
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475
Intervention Description
Pembrolizumab administered intravenously every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Epacadostat
Other Intervention Name(s)
INCB024360
Intervention Description
Epacadostat administered orally twice daily.
Intervention Type
Drug
Intervention Name(s)
Platinum-based chemotherapy
Intervention Description
Investigator selected one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin, depending on histology.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo administered orally twice daily.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Description
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 Outcome Measure Information:
Title
Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Description
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
Title
Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Description
Defined as the time from randomization to death due to any cause.
Time Frame
Up to 24 months
Title
Duration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Description
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
Title
Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Experiencing Adverse Events (AEs)
Description
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
Title
Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Discontinuing Study Drug Due to AEs
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation Measurable disease based on RECIST 1.1 Life expectancy of at least 3 months. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Adequate organ function per protocol-defined criteria. Provide tumor tissue sample. Exclusion Criteria: Known untreated central nervous system metastases and/or carcinomatous meningitis History of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease. Symptomatic ascites or pleural effusion. 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. Active autoimmune disease that has required systemic treatment in past 2 years. Has had an allogeneic tissue/solid organ transplant. Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority. 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. History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful. Use of protocol-defined prior/concomitant therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lance Leopold, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Southern Cancer Center, PC
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Facility Name
Western Regional Medical Center, Inc.
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Facility Name
Arizona Oncology Associates PC- HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Lynn Cancer Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Florida Cancer Specialists (South Region)
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901-8101
Country
United States
Facility Name
Florida Cancer Specialists (North Region)
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
PPG-Oncology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
MMCORC
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
St. Vincent Healthcare Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
New York Oncology Hematology P.C
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Southwestern Regional Medical Center, Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
St. Luke's Hospital - Anderson Campus
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology-Denton South
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
Facility Name
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
Facility Name
Emily Couric Clinical Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
MNCCI Port Macquarie Base Hospital
City
Port Macquarie
State/Province
New South Wales (Australia)
ZIP/Postal Code
2444
Country
Australia
Facility Name
Blacktown Hospital
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Chris OBrien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
The Crown Princess Mary Cancer Centre Westmead
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Southern Medical Day Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Cairns Base Hospital
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
BCCA-Cancer Centre of the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
Lions Gate Hospital
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7L 2L7
Country
Canada
Facility Name
CISSS de la Monteregie-Centre
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
CSSS de Laval- Hopital de la Cite de la Sante
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
CIUSSS Ouest de l'Ile - St-Mary's Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada
Facility Name
CIUSSS du Nord-de-l'ILe-de-Montreal Hopital du Sacre-Coeur de Montreal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
CIUSSS de la Mauricie-et-du-Centre-du-Quebec
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
CHU de Quebec - Hotel-Dieu de Quebec
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Zala Megyei Korhaz Pozvai Telephely
City
Pozva
State/Province
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Orszagos Koranyi TBC es Pulmonologiai Intezet
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Veszprem Megyei Tudogyogyintezet
City
Farkasgyepű
ZIP/Postal Code
8582
Country
Hungary
Facility Name
Bekes Megyei Pandy Kalman Korhaz
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
CRU Hungary Kft.
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
St Vincents University Hospital
City
Dublin
ZIP/Postal Code
Dublin 4
Country
Ireland
Facility Name
Ha Emek Medical Center
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Soroka Medical Center
City
Be'er Sheva
ZIP/Postal Code
8457108
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3525408
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Chaim Sheba Medcal Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Centro Di Riferimento Oncologico
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Ospedale San Gerardo - ASST Monza
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Medical Care Research S.A. de C.V.
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Oaxaca Site Management Organization S.C.
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
FAICIC Clinical Research
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Belgorod Regional Oncology Dispensary
City
Belgorod
ZIP/Postal Code
308010
Country
Russian Federation
Facility Name
Udmurtia Republic Regional Clinical Oncology Dispensary
City
Izhevsk
ZIP/Postal Code
426067
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Tatarstan MoH
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Central Clinical Hospital with polyclinic
City
Moscow
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Moscow Research Oncology Institute
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
SBI of Stavropol region Pyatigorskiy Oncologic dispensary
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
SBHI Leningrad Regional Clinical Hospital
City
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
SBHI Samara Regional Clinical Oncology Dispensary
City
Samara
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
Oncological Dispensary #2 of Ministry of Health of Krasnodar region
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Tomsk Scientific Research Institute of Oncology
City
Tomsk
ZIP/Postal Code
634028
Country
Russian Federation
Facility Name
Hospital Universitario Insular de Gran Canaria
City
Las Palmas De Gran Canaria
State/Province
Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Hospital Juan Ramón Jimenez
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Facility Name
Institut Catala Oncologia de Bellvitge - ICO
City
L'Hospitalet De Llobregat
ZIP/Postal Code
08980
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Chang Gung Medical Foundation, Kaohsiung Branch
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70457
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Chang Gung Medical Foundation, Linkou Branch
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Ege Universitesi Tip Fakultesi Hastanesi
City
İzmir
State/Province
Bornova
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi
City
Adana
ZIP/Postal Code
01120
Country
Turkey
Facility Name
Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Hacettepe Universitesi Tip Fakultesi Hastanesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Uludag Universitesi Tip Fakultesi
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Pamukkale Unv. Tip Fak
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
Facility Name
Istanbul Universitesi Cerrahpasa Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Samsun Medical Park Hastanesi
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Facility Name
Namık Kemal University Medical Faculty
City
Tekirdağ
ZIP/Postal Code
59030
Country
Turkey
Facility Name
Mount Vernon Cancer Centre
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH42XU
Country
United Kingdom
Facility Name
North Middlesex Hospital
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Freeman Hospital Newcastle upon Tyne Foundation NHS Trust
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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)

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