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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03322566
Ethics application status
Date submitted
24/10/2017
Date registered
26/10/2017

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
Timepoint [1] 0 0
Assessed every 12 weeks up to 24 months
Secondary outcome [1] 0 0
Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Duration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Timepoint [3] 0 0
Up to 24 months
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)
Timepoint [4] 0 0
Up to 25 months
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
Timepoint [5] 0 0
Up to 25 months

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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/10/2020
Sample size
Target
Accrual to date
Final
233
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
State/province [37] 0 0
Yucatan
Country [38] 0 0
Mexico
State/province [38] 0 0
Oaxaca
Country [39] 0 0
Mexico
State/province [39] 0 0
Veracruz
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Belgorod
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Izhevsk
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Kazan
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Moscow
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Pyatigorsk
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Saint Petersburg
Country [46] 0 0
Russian Federation
State/province [46] 0 0
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 LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03322566