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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03425643




Registration number
NCT03425643
Ethics application status
Date submitted
2/02/2018
Date registered
7/02/2018

Titles & IDs
Public title
Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)
Scientific title
A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)
Secondary ID [1] 0 0
MK-3475-671
Secondary ID [2] 0 0
3475-671
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell 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: Other - Pembrolizumab
Treatment: Drugs - Placebo
Treatment: Drugs - Cisplatin
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Pemetrexed

Experimental: NAC + Neoadjuvant/Adjuvant Pembrolizumab - Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\].

Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, IV; given on cycle day 1\].

Placebo comparator: NAC + Neoadjuvant/Adjuvant Placebo - Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\] in combination with platinum doublet NAC, consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\].

Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\].


Treatment: Other: Pembrolizumab
200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.

Treatment: Drugs: Placebo
Normal saline by IV infusion Q3W, given on cycle day 1.

Treatment: Drugs: Cisplatin
75 mg/m\^2 by IV infusion Q3W, given on cycle day 1.

Treatment: Drugs: Gemcitabine
1000 mg/m\^2 by IV infusion Q3W, given on cycle days 1 and 8. Given only to participants with squamous NSCLC.

Treatment: Drugs: Pemetrexed
500 mg/m\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Free Survival (EFS)
Timepoint [1] 0 0
Up to approximately 5 years
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Major Pathological Response (mPR) Rate
Timepoint [1] 0 0
Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)
Secondary outcome [2] 0 0
Pathological Complete Response (pCR) Rate
Timepoint [2] 0 0
Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)
Secondary outcome [3] 0 0
Change From Baseline in Neoadjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score
Timepoint [3] 0 0
Baseline (cycle 1 in neoadjuvant phase) and neoadjuvant week 11
Secondary outcome [4] 0 0
Change From Baseline in Adjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score
Timepoint [4] 0 0
Baseline (cycle 1 in neoadjuvant phase) and adjuvant week 10 (up to Study Week 30)
Secondary outcome [5] 0 0
Number of Participants Who Experience an Adverse Event (AE)
Timepoint [5] 0 0
Up to approximately 71 weeks
Secondary outcome [6] 0 0
Number of Participants Who Experience Perioperative Complications
Timepoint [6] 0 0
Up to approximately 51 weeks following surgery
Secondary outcome [7] 0 0
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Timepoint [7] 0 0
Up to approximately 57 weeks

Eligibility
Key inclusion criteria
* Have previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) NSCLC.
* If male, must agree to use contraception or practice abstinence as well as refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention.
* If female, may participate if not pregnant or breastfeeding, and at least one of the following conditions apply: 1) not a woman of childbearing potential (WOCBP); or 2) a WOCBP who agrees to follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period.
* Have available formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks for submission. If blocks are not available, have unstained slides for submission for central programmed death-ligand 1 (PD-L1) testing.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days of randomization.
* Have adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has one of the following tumor locations/types:1) NSCLC involving the superior sulcus; 2) Large cell neuro-endocrine cancer (LCNEC); or 3) Sarcomatoid tumor.
* Has a history of (non-infectious) pneumonitis /interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids.
* Has an active infection requiring systemic therapy.
* Has had an allogenic tissue/sold organ transplant.
* Has a known severe hypersensitivity (= Grade 3) to pembrolizumab, its active substance and/or any of its excipients.
* Has a known severe hypersensitivity (= Grade 3) to any of the study chemotherapy agents and/or to any of their excipients.
* Has an active autoimmune disease that has required systemic treatment in past 2 years.
* Has a known history of human immunodeficiency virus (HIV) infection.
* Has a known history of Hepatitis B or Hepatitis C.
* Has a known history of active tuberculosis.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate.
* Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor.
* Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy prior to randomization/allocation.
* Has received prior radiotherapy within 2 weeks of start of trial treatment.
* Has received a live vaccine within 30 days prior to the first dose of trial drug.
* Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment.
* Has a diagnosis of immunodeficiency or is receiving either systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug.
* Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
24/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/06/2026
Actual
Sample size
Target
Accrual to date
Final
797
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Orange Health Services ( Site 0624) - Orange
Recruitment hospital [2] 0 0
Westmead Hospital ( Site 0621) - Westmead
Recruitment postcode(s) [1] 0 0
2800 - Orange
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
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United States of America
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Iowa
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Montana
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United States of America
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Nebraska
Country [17] 0 0
United States of America
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New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Oregon
Country [21] 0 0
United States of America
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Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Argentina
State/province [25] 0 0
Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Caba
Country [27] 0 0
Argentina
State/province [27] 0 0
Santa Fe
Country [28] 0 0
Argentina
State/province [28] 0 0
Cordoba
Country [29] 0 0
Argentina
State/province [29] 0 0
San Juan
Country [30] 0 0
Belgium
State/province [30] 0 0
Antwerpen
Country [31] 0 0
Belgium
State/province [31] 0 0
Liege
Country [32] 0 0
Belgium
State/province [32] 0 0
Oost-Vlaanderen
Country [33] 0 0
Belgium
State/province [33] 0 0
Vlaams-Brabant
Country [34] 0 0
Belgium
State/province [34] 0 0
West-Vlaanderen
Country [35] 0 0
Brazil
State/province [35] 0 0
Ceara
Country [36] 0 0
Brazil
State/province [36] 0 0
Distrito Federal
Country [37] 0 0
Brazil
State/province [37] 0 0
Rio Grande Do Norte
Country [38] 0 0
Brazil
State/province [38] 0 0
Rio Grande Do Sul
Country [39] 0 0
Brazil
State/province [39] 0 0
Santa Catarina
Country [40] 0 0
Brazil
State/province [40] 0 0
Sao Paulo
Country [41] 0 0
Brazil
State/province [41] 0 0
Rio de Janeiro
Country [42] 0 0
Canada
State/province [42] 0 0
Ontario
Country [43] 0 0
Canada
State/province [43] 0 0
Quebec
Country [44] 0 0
China
State/province [44] 0 0
Anhui
Country [45] 0 0
China
State/province [45] 0 0
Beijing
Country [46] 0 0
China
State/province [46] 0 0
Guangdong
Country [47] 0 0
China
State/province [47] 0 0
Hunan
Country [48] 0 0
China
State/province [48] 0 0
Shanghai
Country [49] 0 0
China
State/province [49] 0 0
Shanxi
Country [50] 0 0
China
State/province [50] 0 0
Zhejiang
Country [51] 0 0
Estonia
State/province [51] 0 0
Harjumaa
Country [52] 0 0
France
State/province [52] 0 0
Ain
Country [53] 0 0
France
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Bas-Rhin
Country [54] 0 0
France
State/province [54] 0 0
Haute-Garonne
Country [55] 0 0
France
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Haute-Vienne
Country [56] 0 0
France
State/province [56] 0 0
Rhone-Alpes
Country [57] 0 0
France
State/province [57] 0 0
Savoie
Country [58] 0 0
France
State/province [58] 0 0
Seine-Maritime
Country [59] 0 0
France
State/province [59] 0 0
Seine-Saint-Denis
Country [60] 0 0
France
State/province [60] 0 0
Var
Country [61] 0 0
France
State/province [61] 0 0
Paris
Country [62] 0 0
Germany
State/province [62] 0 0
Baden-Wurttemberg
Country [63] 0 0
Germany
State/province [63] 0 0
Hessen
Country [64] 0 0
Germany
State/province [64] 0 0
Nordrhein-Westfalen
Country [65] 0 0
Germany
State/province [65] 0 0
Rheinland-Pfalz
Country [66] 0 0
Germany
State/province [66] 0 0
Sachsen
Country [67] 0 0
Germany
State/province [67] 0 0
Schleswig-Holstein
Country [68] 0 0
Germany
State/province [68] 0 0
Thuringen
Country [69] 0 0
Germany
State/province [69] 0 0
Berlin
Country [70] 0 0
Germany
State/province [70] 0 0
Hamburg
Country [71] 0 0
Ireland
State/province [71] 0 0
Cork
Country [72] 0 0
Ireland
State/province [72] 0 0
Dublin
Country [73] 0 0
Ireland
State/province [73] 0 0
Limerick
Country [74] 0 0
Italy
State/province [74] 0 0
Abruzzo
Country [75] 0 0
Italy
State/province [75] 0 0
Campania
Country [76] 0 0
Italy
State/province [76] 0 0
Forli-Cesena
Country [77] 0 0
Italy
State/province [77] 0 0
Lombardia
Country [78] 0 0
Italy
State/province [78] 0 0
Milano
Country [79] 0 0
Italy
State/province [79] 0 0
Monza E Brianza
Country [80] 0 0
Italy
State/province [80] 0 0
Torino
Country [81] 0 0
Italy
State/province [81] 0 0
Brescia
Country [82] 0 0
Italy
State/province [82] 0 0
Roma
Country [83] 0 0
Japan
State/province [83] 0 0
Aichi
Country [84] 0 0
Japan
State/province [84] 0 0
Chiba
Country [85] 0 0
Japan
State/province [85] 0 0
Fukuoka
Country [86] 0 0
Japan
State/province [86] 0 0
Hyogo
Country [87] 0 0
Japan
State/province [87] 0 0
Kanagawa
Country [88] 0 0
Japan
State/province [88] 0 0
Oita
Country [89] 0 0
Japan
State/province [89] 0 0
Fukushima
Country [90] 0 0
Japan
State/province [90] 0 0
Hiroshima
Country [91] 0 0
Japan
State/province [91] 0 0
Tokyo
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Kyonggi-do
Country [93] 0 0
Korea, Republic of
State/province [93] 0 0
Seoul
Country [94] 0 0
Latvia
State/province [94] 0 0
Riga
Country [95] 0 0
Lithuania
State/province [95] 0 0
Kaunas
Country [96] 0 0
Lithuania
State/province [96] 0 0
Vilnius
Country [97] 0 0
Malaysia
State/province [97] 0 0
Sarawak
Country [98] 0 0
Malaysia
State/province [98] 0 0
Kuala Lumpur
Country [99] 0 0
Poland
State/province [99] 0 0
Dolnoslaskie
Country [100] 0 0
Poland
State/province [100] 0 0
Kujawsko-pomorskie
Country [101] 0 0
Poland
State/province [101] 0 0
Lodzkie
Country [102] 0 0
Poland
State/province [102] 0 0
Pomorskie
Country [103] 0 0
Poland
State/province [103] 0 0
Wielkopolskie
Country [104] 0 0
Romania
State/province [104] 0 0
Bihor
Country [105] 0 0
Romania
State/province [105] 0 0
Bucuresti
Country [106] 0 0
Romania
State/province [106] 0 0
Cluj
Country [107] 0 0
Romania
State/province [107] 0 0
Dolj
Country [108] 0 0
Romania
State/province [108] 0 0
Ilfov
Country [109] 0 0
Romania
State/province [109] 0 0
Timis
Country [110] 0 0
Romania
State/province [110] 0 0
Brasov
Country [111] 0 0
Romania
State/province [111] 0 0
Constanta
Country [112] 0 0
Romania
State/province [112] 0 0
Suceava
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Chelyabinskaya Oblast
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Moskva
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Sankt-Peterburg
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Tatarstan, Respublika
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Tomskaya Oblast
Country [118] 0 0
South Africa
State/province [118] 0 0
Gauteng
Country [119] 0 0
South Africa
State/province [119] 0 0
Kwazulu-Natal
Country [120] 0 0
South Africa
State/province [120] 0 0
Western Cape
Country [121] 0 0
Spain
State/province [121] 0 0
Barcelona
Country [122] 0 0
Spain
State/province [122] 0 0
La Coruna
Country [123] 0 0
Spain
State/province [123] 0 0
Las Palmas
Country [124] 0 0
Spain
State/province [124] 0 0
Madrid
Country [125] 0 0
Spain
State/province [125] 0 0
Sevilla
Country [126] 0 0
Taiwan
State/province [126] 0 0
Kaohsiung
Country [127] 0 0
Taiwan
State/province [127] 0 0
Taichung
Country [128] 0 0
Taiwan
State/province [128] 0 0
Taipei
Country [129] 0 0
Taiwan
State/province [129] 0 0
Taoyuan
Country [130] 0 0
Ukraine
State/province [130] 0 0
Cherkaska Oblast
Country [131] 0 0
Ukraine
State/province [131] 0 0
Dnipropetrovska Oblast
Country [132] 0 0
Ukraine
State/province [132] 0 0
Ivano-Frankivska Oblast
Country [133] 0 0
Ukraine
State/province [133] 0 0
Khersonska Oblast
Country [134] 0 0
Ukraine
State/province [134] 0 0
Kirovohradska Oblast
Country [135] 0 0
Ukraine
State/province [135] 0 0
Kyivska Oblast
Country [136] 0 0
Ukraine
State/province [136] 0 0
Odeska Oblast
Country [137] 0 0
Ukraine
State/province [137] 0 0
Zaporizka Oblast
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Leicestershire
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Liverpool
Country [140] 0 0
United Kingdom
State/province [140] 0 0
London, City Of
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Nottinghamshire
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Birmingham
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Newcastle upon Tyne
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
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)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT03425643