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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03829332




Registration number
NCT03829332
Ethics application status
Date submitted
1/02/2019
Date registered
4/02/2019
Date last updated
21/08/2019

Titles & IDs
Public title
Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Non-small Cell Lung Cancer (NSCLC)(MK-7902-007/E7080-G000-314/LEAP-007)
Scientific title
A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Non-small Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)
Secondary ID [1] 0 0
MK-7902-007
Secondary ID [2] 0 0
7902-007
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
Other interventions - Pembrolizumab
Treatment: Drugs - Lenvatinib
Treatment: Drugs - Placebo for lenvatinib

Experimental: Pembrolizumab + Lenvatinib - Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.

Active Comparator: Pembrolizumab + Placebo - Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.


Other interventions: Pembrolizumab
IV infusion

Treatment: Drugs: Lenvatinib
oral capsule

Treatment: Drugs: Placebo for lenvatinib
oral capsule

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - PFS is defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. Note: The appearance of one or more new lesions is also considered PD. PFS as assessed per RECIST 1.1 will be presented.
Timepoint [1] 0 0
Up to approximately 24 months
Primary outcome [2] 0 0
Overall Survival (OS) - OS is defined as the time from date of randomization to date of death from any cause. OS will be presented.
Timepoint [2] 0 0
Up to approximately 60 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed per RECIST 1.1 will be presented.
Timepoint [1] 0 0
Up to approximately 24 months
Secondary outcome [2] 0 0
Number of Participants Who Experience an Adverse Event (AE) - An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.
Timepoint [2] 0 0
Through 90 days post last dose of study treatment (Up to approximately 27 months)
Secondary outcome [3] 0 0
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) - The number of participants who discontinue study treatment due to an AE will be presented.
Timepoint [3] 0 0
Through last dose of study treatment (Up to approximately 24 months)
Secondary outcome [4] 0 0
Change from Baseline in Global Health Status (GHS)(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] Item 29) Score - The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) score will be presented. A higher score indicates a better overall GHS.
Timepoint [4] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [5] 0 0
Change from Baseline in Quality of Life (QoL)(EORTC QLQ-C30 Item 30) Score - The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question " How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in QoL (EORTC QLQ-C30 Item 30) score will be presented. A higher score indicates a better overall QoL.
Timepoint [5] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [6] 0 0
Change from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score - The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in cough (EORTC QLQ-LC13 Item 31) score will be presented. A lower score indicates a better outcome.
Timepoint [6] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [7] 0 0
Change from Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score - The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.
Timepoint [7] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [8] 0 0
Change from Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score - The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented. A lower score indicates a better outcome.
Timepoint [8] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [9] 0 0
Change from Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score - The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented. A higher score indicates a better quality of life.
Timepoint [9] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [10] 0 0
Time to True Deterioration (TTD) Based on Change from Baseline in Global Health Status (GHS)(EORTC QLQ-C30 Item 29) Score - TTD is defined as the time from Baseline to the first onset of a =10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Item 29) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.
Timepoint [10] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [11] 0 0
Time to True Deterioration (TTD) Based on Change from Baseline in Quality of Life (QoL)(EORTC QLQ-C30 Item 30) Score - TTD is defined as the time from Baseline to the first onset of a =10-point negative change (decrease) from Baseline in QoL (EORTC QLQ-C30 Item 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point negative change (decrease) from Baseline in QoL score, will be presented. A longer TTD indicates a better outcome.
Timepoint [11] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [12] 0 0
Time to True Deterioration (TTD) Based on Change from Baseline in the Composite Endpoint of Cough & Chest Pain (EORTC QLQ-LC13 Items 31 & 40) or Dyspnea (EORTC QLQ-C30 Item 8) - TTD is defined as the time from Baseline to the first onset of a =10-point negative change (decrease) from Baseline in the composite endpoint of cough & chest pain (EORTC QLQ-LC13 Items 31 & 40) & dyspnea (EORTC QLQ-C30 Item 8). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point negative change (decrease) from Baseline in the composite endpoint of cough, chest pain or dyspnea, will be presented. A longer TTD indicates a better outcome.
Timepoint [12] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [13] 0 0
Time to True Deterioration (TTD) Based on Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score - TTD is defined as the time from Baseline to the first onset of a =10-point negative change (decrease) from Baseline in physical functioning (EORTC QLQ-C30 Items 1-5) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point negative change (decrease) from Baseline in physical functioning score, will be presented.
Timepoint [13] 0 0
Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)

Eligibility
Key inclusion criteria
- Has a histologically or cytologically confirmed diagnosis of NSCLC.

- Has Stage IV NSCLC (American Joint Committee on Cancer [AJCC]).

- Has measurable disease based on RECIST 1.1.

- Has tumor tissue that demonstrates programmed cell death-ligand 1 (PD-L1) expression
in =1% of tumor cells (Tumor Proportion Score [TPS] =1%) as assessed by
immunohistochemistry (IHC) 22C3 pharmDx assay (Dako North America, Inc.) at a central
laboratory.

- Has a life expectancy of =3 months.

- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7
days before the first dose of study treatment but before randomization.

- Male participants must agree to the following during the treatment period and for =30
days after the last dose of lenvatinib/matching placebo: 1) Be abstinent from
heterosexual intercourse as their preferred and usual lifestyle and agree to remain
abstinent, OR 2) Must agree to use contraception unless confirmed to be azoospermic
(vasectomized or secondary to medical cause).

- Female participants are eligible to participate if not pregnant or breastfeeding, and
=1 of the following applies: 1) Is not a woman of child-bearing potential (WOCBP), OR
2) Is a WOCBP and is using a highly effective contraceptive method that has a low user
dependency, or be abstinent from heterosexual intercourse as their preferred and usual
lifestyle during the treatment period and for =120 days post pembrolizumab or =30 days
post lenvatinib/matching placebo, whichever occurs last.

- Has adequately controlled blood pressure (BP) with or without antihypertensive
medications, defined as BP =150/90 mm Hg and no change in antihypertensive medications
within 1 week before randomization.

- Has adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has known untreated central nervous system metastases and/or carcinomatous meningitis.

- 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
=3 years since initiation of that therapy. (Note: The time requirement 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.)

- Has an active autoimmune disease that has required systemic treatment in the past 2
years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
form of systemic treatment and is allowed.

- Has had an allogeneic tissue/solid organ transplant.

- Has a known history of human immunodeficiency virus (HIV) infection.

- Has a history of (noninfectious) pneumonitis that required systemic steroids or
current pneumonitis/interstitial lung disease.

- Has a known history of hepatitis B or known active hepatitis C virus infection.

- Has a history of a gastrointestinal condition or procedure that in the opinion of the
investigator may affect oral study drug absorption.

- Has significant cardiovascular impairment within 12 months of the first dose of study
treatment, such as a history of congestive heart failure greater than New York Heart
Association Class II, unstable angina, myocardial infarction, cerebrovascular
accident/stroke, or cardiac arrhythmia associated with hemodynamic instability.

- Has not recovered adequately from any toxicity and/or complications from major surgery
before starting study treatment.

- Has a known history of active tuberculosis (TB).

- Has an active infection requiring systemic therapy.

- Has previously had a severe hypersensitivity reaction to treatment with a monoclonal
antibody or has a known sensitivity or intolerance to any component of lenvatinib or
pembrolizumab.

- 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 study treatment.

- Has received prior systemic chemotherapy or other targeted or biological
antineoplastic therapy for their metastatic NSCLC.

- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with
an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.
cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor
superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9
[CD137]) or has received lenvatinib as monotherapy or in combination with anti-
programmed cell death protein (anti-PD-1) agents.

- Has received radiotherapy within 14 days before the first dose of study treatment or
received lung radiation therapy of >30 Gray (Gy) within 6 months before the first dose
of study treatment. (Note: Participants must have recovered from all radiation-related
toxicities to =Grade 1, not require corticosteroids, and not have had radiation
pneumonitis.)

- Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive
therapy within 7 days before the first dose of study treatment.

- Is receiving systemic steroid therapy (doses >10 mg daily of prednisone equivalent)
within 7 days before the first dose of study treatment.

- Has received a live vaccine within 30 days before the first dose of study treatment.

- Has had major surgery within 3 weeks prior to first dose of study treatment

- Has pre-existing =Grade 3 gastrointestinal or non-gastrointestinal fistula.

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 assessing the outcomes
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
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,QLD,VIC
Recruitment hospital [1] 0 0
Orange Health Services ( Site 0002) - Orange
Recruitment hospital [2] 0 0
Wollongong Private Hospital ( Site 0005) - Wollongong
Recruitment hospital [3] 0 0
The Prince Charles Hospital ( Site 0011) - Chermside
Recruitment hospital [4] 0 0
Ballarat Oncology and Haematology Services ( Site 0008) - Wendouree
Recruitment hospital [5] 0 0
St John of God Murdoch Medical Clinic ( Site 0001) - Perth
Recruitment postcode(s) [1] 0 0
2800 - Orange
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
3355 - Wendouree
Recruitment postcode(s) [5] 0 0
6150 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
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
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Montana
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Colombia
State/province [16] 0 0
Antioquia
Country [17] 0 0
Colombia
State/province [17] 0 0
Valle Del Cauca
Country [18] 0 0
Colombia
State/province [18] 0 0
Medellin
Country [19] 0 0
Colombia
State/province [19] 0 0
Monteria
Country [20] 0 0
Estonia
State/province [20] 0 0
Tallinn
Country [21] 0 0
Estonia
State/province [21] 0 0
Tallin
Country [22] 0 0
Estonia
State/province [22] 0 0
Tartu
Country [23] 0 0
France
State/province [23] 0 0
Amiens
Country [24] 0 0
France
State/province [24] 0 0
Bayonne
Country [25] 0 0
France
State/province [25] 0 0
Besancon
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France
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La Tronche
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France
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Montpellier
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France
State/province [28] 0 0
Rouen
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France
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Saint Herblain
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France
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Toulon
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Hungary
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Pest
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Hungary
State/province [32] 0 0
Gyor
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Hungary
State/province [33] 0 0
Gyula
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Hungary
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Kaposvar
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Hungary
State/province [35] 0 0
Miskolc
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Hungary
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Szolnok
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Israel
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Ashkelon
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Israel
State/province [38] 0 0
Beer Sheva
Country [39] 0 0
Israel
State/province [39] 0 0
Haifa
Country [40] 0 0
Israel
State/province [40] 0 0
Kfar-Saba
Country [41] 0 0
Israel
State/province [41] 0 0
Petah Tikva
Country [42] 0 0
Israel
State/province [42] 0 0
Ramat Gan
Country [43] 0 0
Israel
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Tel Aviv
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Italy
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Avellino
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Italy
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Aviano
Country [46] 0 0
Italy
State/province [46] 0 0
Catanzaro
Country [47] 0 0
Italy
State/province [47] 0 0
Firenze
Country [48] 0 0
Italy
State/province [48] 0 0
Ravenna
Country [49] 0 0
Italy
State/province [49] 0 0
Roma
Country [50] 0 0
Italy
State/province [50] 0 0
Taormina
Country [51] 0 0
Japan
State/province [51] 0 0
Aichi
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Japan
State/province [52] 0 0
Fukuoka
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Osaka
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Japan
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Okayama
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Japan
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Tokyo
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Korea, Republic of
State/province [61] 0 0
Ulsan
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Malaysia
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Pahang Darul Makmar
Country [63] 0 0
Malaysia
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Sarawak
Country [64] 0 0
Malaysia
State/province [64] 0 0
Wilayah Persekutuan
Country [65] 0 0
Malaysia
State/province [65] 0 0
Kuala Lumpur
Country [66] 0 0
Malaysia
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Pulau Pinang
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Poland
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Malopolskie
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Poland
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Krakow
Country [69] 0 0
Poland
State/province [69] 0 0
Ostroleka
Country [70] 0 0
Poland
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Pila
Country [71] 0 0
Poland
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Przemysl
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Poland
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Warszawa
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Poland
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Zielona Gora
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Russian Federation
State/province [74] 0 0
Krasnoyarsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Samara
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Russian Federation
State/province [77] 0 0
Ufa
Country [78] 0 0
Taiwan
State/province [78] 0 0
Hsinchu
Country [79] 0 0
Taiwan
State/province [79] 0 0
New Taipei
Country [80] 0 0
Taiwan
State/province [80] 0 0
Tainan
Country [81] 0 0
Taiwan
State/province [81] 0 0
Taipei
Country [82] 0 0
Turkey
State/province [82] 0 0
Ankara
Country [83] 0 0
Turkey
State/province [83] 0 0
Antalya
Country [84] 0 0
Turkey
State/province [84] 0 0
Izmir
Country [85] 0 0
Turkey
State/province [85] 0 0
Konya
Country [86] 0 0
Turkey
State/province [86] 0 0
Sakarya
Country [87] 0 0
Turkey
State/province [87] 0 0
Samsun
Country [88] 0 0
Ukraine
State/province [88] 0 0
Cherkasy
Country [89] 0 0
Ukraine
State/province [89] 0 0
Dnipropetrovsk
Country [90] 0 0
Ukraine
State/province [90] 0 0
Ivano-Frankivsk
Country [91] 0 0
Ukraine
State/province [91] 0 0
Kyiv
Country [92] 0 0
Ukraine
State/province [92] 0 0
Lviv
Country [93] 0 0
Ukraine
State/province [93] 0 0
Odesa
Country [94] 0 0
Ukraine
State/province [94] 0 0
Vinnytsia

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475)
combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for
lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic
non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1)
Tumor Proportion Score (TPS) greater than or equal to 1%.

The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is
superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response
Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of
pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall
Survival (OS).
Trial website
https://clinicaltrials.gov/show/NCT03829332
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Medical Director
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Merck Sharp & Dohme Corp.
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Contact person for public queries
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Toll Free Number
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1-888-577-8839
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Trialsites@merck.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03829332