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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03322566




Registration number
NCT03322566
Ethics application status
Date submitted
24/10/2017
Date registered
26/10/2017
Date last updated
29/01/2020

Titles & IDs
Public 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)
Scientific 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
Secondary ID [1] 0 0
2017-001810-27
Secondary ID [2] 0 0
KEYNOTE-715-06/ECHO-306-06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Epacadostat
Treatment: Drugs - Platinum-based chemotherapy
Treatment: Drugs - Placebo

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).

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).

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.


Treatment: Drugs: Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.

Treatment: Drugs: Epacadostat
Epacadostat administered orally twice daily.

Treatment: Drugs: Platinum-based chemotherapy
Investigator selected one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin, depending on histology.

Treatment: Drugs: Placebo
Matching placebo administered orally twice daily.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
Assessed after a minimum of 12 weeks of follow-up ( Data Cut Off of 13-Dec 18).
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Assessed from the start of the study until death or PD, whichever was earlier until the Data Cut Off of 13-Dec 18.
Secondary outcome [2] 0 0
Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo - Defined as the time from randomization to death due to any cause.
Timepoint [2] 0 0
Assessed from the start of study until the Data Cut Off of 13-Dec 18.
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Assessed from the fist dose until the Data Cut Off of 13-Dec 18.
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Assessed from the fist dose until the Data Cut Off of 13-Dec 18.
Secondary outcome [5] 0 0
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 study treatment, whether or not considered related to the study treatment.
Timepoint [5] 0 0
Assessed from the fist dose until the Data Cut Off of 13-Dec 18.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW, (Australia)NSW,QLD
Recruitment hospital [1] 0 0
MNCCI Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [2] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [3] 0 0
Chris OBrien Lifehouse - Camperdown
Recruitment hospital [4] 0 0
The Crown Princess Mary Cancer Centre Westmead - Westmead
Recruitment hospital [5] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment hospital [6] 0 0
Cairns Base Hospital - Cairns
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
2500 - Wollongong
Recruitment postcode(s) [6] 0 0
4870 - Cairns
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Montana
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Hungary
State/province [18] 0 0
Zalaegerszeg
Country [19] 0 0
Hungary
State/province [19] 0 0
Budapest
Country [20] 0 0
Hungary
State/province [20] 0 0
Farkasgyepu
Country [21] 0 0
Hungary
State/province [21] 0 0
Gyula
Country [22] 0 0
Hungary
State/province [22] 0 0
Miskolc
Country [23] 0 0
Hungary
State/province [23] 0 0
Szolnok
Country [24] 0 0
Ireland
State/province [24] 0 0
Dublin
Country [25] 0 0
Israel
State/province [25] 0 0
Afula
Country [26] 0 0
Israel
State/province [26] 0 0
Be'er Sheva
Country [27] 0 0
Israel
State/province [27] 0 0
Haifa
Country [28] 0 0
Israel
State/province [28] 0 0
Kfar Saba
Country [29] 0 0
Israel
State/province [29] 0 0
Petah Tikva
Country [30] 0 0
Israel
State/province [30] 0 0
Ramat Gan
Country [31] 0 0
Italy
State/province [31] 0 0
Aviano
Country [32] 0 0
Italy
State/province [32] 0 0
Catania
Country [33] 0 0
Italy
State/province [33] 0 0
Milano
Country [34] 0 0
Italy
State/province [34] 0 0
Monza
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Goyang-si
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Seoul
Country [37] 0 0
Mexico
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Yucatan
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Mexico
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Oaxaca
Country [39] 0 0
Mexico
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Veracruz
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Belgorod
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Russian Federation
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Izhevsk
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Russian Federation
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Kazan
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Russian Federation
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Moscow
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Pyatigorsk
Country [45] 0 0
Russian Federation
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Saint Petersburg
Country [46] 0 0
Russian Federation
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Samara
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Sochi
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Tomsk
Country [49] 0 0
Spain
State/province [49] 0 0
Gran Canaria
Country [50] 0 0
Spain
State/province [50] 0 0
Huelva
Country [51] 0 0
Spain
State/province [51] 0 0
L'Hospitalet De Llobregat
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Spain
State/province [53] 0 0
Valencia
Country [54] 0 0
Spain
State/province [54] 0 0
Zaragoza
Country [55] 0 0
Taiwan
State/province [55] 0 0
Kaohsiung
Country [56] 0 0
Taiwan
State/province [56] 0 0
Taichung
Country [57] 0 0
Taiwan
State/province [57] 0 0
Tainan
Country [58] 0 0
Taiwan
State/province [58] 0 0
Taipei
Country [59] 0 0
Taiwan
State/province [59] 0 0
Taoyuan
Country [60] 0 0
Turkey
State/province [60] 0 0
Bornova
Country [61] 0 0
Turkey
State/province [61] 0 0
Adana
Country [62] 0 0
Turkey
State/province [62] 0 0
Ankara
Country [63] 0 0
Turkey
State/province [63] 0 0
Bursa
Country [64] 0 0
Turkey
State/province [64] 0 0
Denizli
Country [65] 0 0
Turkey
State/province [65] 0 0
Istanbul
Country [66] 0 0
Turkey
State/province [66] 0 0
Samsun
Country [67] 0 0
Turkey
State/province [67] 0 0
Tekirdag
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Middlesex
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Edinburgh
Country [70] 0 0
United Kingdom
State/province [70] 0 0
London
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Incyte Corporation
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT03322566
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lance Leopold, MD
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications