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Trial record 33 of 198 for:    Oral Cancer | ( Map: Mexico )

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03829332
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : January 21, 2020
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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).


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Biological: Pembrolizumab Drug: Lenvatinib Drug: Placebo for lenvatinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : March 8, 2022
Estimated Study Completion Date : March 8, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®

Drug: Lenvatinib
oral capsule
Other Names:
  • MK-7902
  • E7080
  • LENVIMA®

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.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®

Drug: Placebo for lenvatinib
oral capsule




Primary Outcome Measures :
  1. Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 24 months ]
    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.

  2. Overall Survival (OS) [ Time Frame: Up to approximately 60 months ]
    OS is defined as the time from date of randomization to date of death from any cause. OS will be presented.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 24 months ]
    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.

  2. Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Through 90 days post last dose of study treatment (Up to approximately 27 months) ]
    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.

  3. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) [ Time Frame: Through last dose of study treatment (Up to approximately 24 months) ]
    The number of participants who discontinue study treatment due to an AE will be presented.

  4. 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 [ Time Frame: 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) ]
    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.

  5. Change from Baseline in Quality of Life (QoL)(EORTC QLQ-C30 Item 30) Score [ Time Frame: 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) ]
    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.

  6. Change from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score [ Time Frame: 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) ]
    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.

  7. Change from Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score [ Time Frame: 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) ]
    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.

  8. Change from Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score [ Time Frame: 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) ]
    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.

  9. Change from Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score [ Time Frame: 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) ]
    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.

  10. Time to True Deterioration (TTD) Based on Change from Baseline in Global Health Status (GHS)(EORTC QLQ-C30 Item 29) Score [ Time Frame: 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) ]
    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.

  11. Time to True Deterioration (TTD) Based on Change from Baseline in Quality of Life (QoL)(EORTC QLQ-C30 Item 30) Score [ Time Frame: 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) ]
    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.

  12. 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) [ Time Frame: 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) ]
    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.

  13. Time to True Deterioration (TTD) Based on Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score [ Time Frame: 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) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829332


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
Hide Hide 147 study locations
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United States, Alaska
Alaska Clinical Research Center ( Site 0511) Recruiting
Anchorage, Alaska, United States, 99503
Contact: Study Coordinator    907-276-1455      
United States, Arizona
Ironwood Cancer & Research Centers ( Site 0541) Recruiting
Chandler, Arizona, United States, 85224
Contact: Study Coordinator    480-324-5230      
United States, California
CBCC Global Research, Inc. ( Site 0532) Recruiting
Bakersfield, California, United States, 93309
Contact: Study Coordinator    661-862-8548      
Scripps Cancer Center ( Site 0521) Recruiting
La Jolla, California, United States, 92037
Contact: Study Coordinator    858-554-8277      
United States, Florida
Florida Hospital ( Site 0526) Recruiting
Orlando, Florida, United States, 32803
Contact: Study Coordinator    407-303-2523      
United States, Georgia
Northwest Georgia Oncology Centers PC ( Site 0518) Recruiting
Marietta, Georgia, United States, 30060
Contact: Study Coordinator    770-333-2161      
United States, Illinois
Illinois Cancer Care, PC ( Site 0557) Recruiting
Peoria, Illinois, United States, 61615
Contact: Study Coordinator    309-243-3000      
United States, Indiana
Parkview Cancer Center ( Site 0542) Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Study Coordinator    260-266-7744      
United States, Kentucky
University of Kentucky School of Medicine & Hospitals ( Site 0517) Recruiting
Lexington, Kentucky, United States, 40536
Contact: Study Coordinator    859-218-6704      
United States, Maryland
Anne Arundel Medical Center Oncology and Hematology ( Site 0514) Recruiting
Annapolis, Maryland, United States, 21401
Contact: Study Coordinator    443-481-4390      
United States, Michigan
Munson Medical Center ( Site 0512) Recruiting
Traverse City, Michigan, United States, 49684
Contact: Study Coordinator    231-392-8400      
United States, Minnesota
Park Nicollet Frauenshuh Cancer Center ( Site 0554) Recruiting
Saint Louis Park, Minnesota, United States, 55426
Contact: Study Coordinator    952-993-6705      
United States, Missouri
University of Missouri Health Care ( Site 0555) Recruiting
Columbia, Missouri, United States, 65212
Contact: Study Coordinator    573-882-7440      
United States, Montana
Billings Clinic Cancer Center ( Site 0508) Recruiting
Billings, Montana, United States, 59101
Contact: Study Coordinator    406-435-7484      
United States, North Carolina
Cone Health Cancer Center at Alamance Regional ( Site 0527) Recruiting
Greensboro, North Carolina, United States, 27403
Contact: Study Coordinator    336-832-0820      
United States, Ohio
Genesis Cancer Care Center ( Site 0559) Recruiting
Zanesville, Ohio, United States, 43701
Contact: Study Coordinator    740-450-6351      
United States, Oregon
Oregon Health Sciences University ( Site 0544) Recruiting
Portland, Oregon, United States, 97239
Contact: Study Coordinator    503-494-8666      
United States, Texas
Central Texas Veterans Healthcare System ( Site 0533) Recruiting
Temple, Texas, United States, 76504
Contact: Study Coordinator    254-743-1226      
Australia, New South Wales
Orange Health Services ( Site 0002) Recruiting
Orange, New South Wales, Australia, 2800
Contact: Study Coordinator    +61263693127      
Wollongong Private Hospital ( Site 0005) Recruiting
Wollongong, New South Wales, Australia, 2500
Contact: Study Coordinator    +61242273733      
Australia, Queensland
The Prince Charles Hospital ( Site 0011) Recruiting
Chermside, Queensland, Australia, 4032
Contact: Study Coordinator    +61731394000      
Australia, Victoria
Ballarat Oncology and Haematology Services ( Site 0008) Recruiting
Wendouree, Victoria, Australia, 3355
Contact: Study Coordinator    +61353398000      
Australia
St John of God Murdoch Medical Clinic ( Site 0001) Recruiting
Perth, Australia, 6150
Contact: Study Coordinator    +61893462432      
Canada, Alberta
Cross Cancer Institute ( Site 0400) Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Study Coordinator    7804328762      
Canada, British Columbia
Lions Gate Hospital ( Site 0407) Recruiting
North Vancouver, British Columbia, Canada, V7L 2L7
Contact: Study Coordinator    6049845753      
Canada, Ontario
William Osler Health System (Brampton Civic Hospital) ( Site 0402) Recruiting
Brampton, Ontario, Canada, L6R 3J7
Contact: Study Coordinator    905494212058389      
Windsor Regional Cancer Program ( Site 0404) Recruiting
Windsor, Ontario, Canada, N8W 2X3
Contact: Study Coordinator    5192535253      
China, Anhui
Anhui Provincial Hospital ( Site 0108) Recruiting
Hefei, Anhui, China, 230001
Contact: Study Coordinator    +8655162283472      
China, Hunan
Zhongshan Hospital Fudan University ( Site 0100) Recruiting
Shanghai, Hunan, China, 200433
Contact: Study Coordinator    +8613601783113      
China, Shanghai
Shanghai Chest Hospital ( Site 0112) Recruiting
Shanghai, Shanghai, China, 230000
Contact: Study Coordinator    8602122200000      
China, Zhejiang
The First Affiliated Hospital Zhejiang University ( Site 0106) Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Study Coordinator    +8613505719970      
Hangzhou First People's Hospital ( Site 0109) Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Study Coordinator    +057156007501      
China
Peking Union Medical College Hospital ( Site 0105) Recruiting
Beijing, China, 100032
Contact: Study Coordinator    +8613911339836      
2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0114) Recruiting
Hangzhou, China, 310009
Contact: Study Coordinator    +8657187783777      
Colombia
Fundacion Centro de Investigacion Clinica CIC ( Site 0366) Recruiting
Medellin, Antioquia, Colombia, 050021
Contact: Study Coordinator    +5745115791      
Biomelab S A S ( Site 0365) Recruiting
Barranquilla, Colombia, 080002
Contact: Study Coordinator    +573174411359      
Centro Medico Imbanaco de Cali S.A ( Site 0369) Recruiting
Cali, Colombia, 760023
Contact: Study Coordinator    +573155760189      
Hospital General de Medellin Luz Castro de Gutierrez ( Site 0368) Recruiting
Medellin, Colombia, 500515
Contact: Study Coordinator    +5743847354      
Oncomedica S.A. ( Site 0372) Recruiting
Monteria, Colombia, 230002
Contact: Study Coordinator    +573158441430      
Sociedad de Oncologia y Hematologia del Cesar Ltda. ( Site 0374) Recruiting
Valledupar, Colombia, 200002
Contact: Study Coordinator    +573128385292      
Estonia
AS Ida-Tallinna Keskhaigla ( Site 0161) Recruiting
Tallinn, Estonia, 11312
Contact: Study Coordinator    +3726067652      
SA Pohja-Eesti Regionaalhaigla ( Site 0162) Recruiting
Tallin, Estonia, 13419
Contact: Study Coordinator    +3726172436      
SA Tartu Ulikooli Kliinikum ( Site 0160) Recruiting
Tartu, Estonia, 51014
Contact: Study Coordinator    +3725513443      
France
CHU Amiens Sud ( Site 0182) Recruiting
Amiens, France, 80054
Contact: Study Coordinator    +322087990      
Centre Hospitalier de la Cote Basque ( Site 0173) Recruiting
Bayonne, France, 64109
Contact: Study Coordinator    +33559443158      
CHU Jean Minjoz ( Site 0167) Recruiting
Besancon, France, 25000
Contact: Study Coordinator    +33370632440      
CHU de Grenoble - Hopital Michallon ( Site 0169) Recruiting
La Tronche, France, 38700
Contact: Study Coordinator    +33476765143      
ICM Val D Auerelle ( Site 0177) Recruiting
Montpellier, France, 34090
Contact: Study Coordinator    +33467612515      
Institut Curie ( Site 0166) Recruiting
Paris, France, 75005
Contact: Study Coordinator    +33144324606      
CHU de Rouen ( Site 0174) Recruiting
Rouen, France, 76000
Contact: Study Coordinator    +33637886045      
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0185) Recruiting
Saint Herblain, France, 44805
Contact: Study Coordinator    +33240679900      
Institut Curie - Centre Rene Huguenin ( Site 0181) Recruiting
Saint-Cloud, France, 92210
Contact: Study Coordinator    +33147111519      
Centre hospitalier Toulon Sainte-Musse ( Site 0172) Recruiting
Toulon, France, 83056
Contact: Study Coordinator    +33494145618      
Hungary
Tudogyogyintezet Torokbalint ( Site 0205) Recruiting
Torokbalint, Pest, Hungary, 2045
Contact: Study Coordinator    +36307005601      
Semmelweis Egyetem ( Site 0210) Recruiting
Budapest, Hungary, 1083
Contact: Study Coordinator    +3613559733      
Petz Aladar Megyei Oktato Korhaz ( Site 0213) Recruiting
Gyor, Hungary, 9024
Contact: Study Coordinator    +36309758356      
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0207) Recruiting
Gyula, Hungary, 5700
Contact: Study Coordinator    +36704533531      
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0217) Recruiting
Kaposvar, Hungary, 7400
Contact: Study Coordinator    +36703685838      
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz ( Site 0202) Recruiting
Miskolc, Hungary, 3529
Contact: Study Coordinator    +3646555648      
CRU Hungary KFT ( Site 0209) Recruiting
Miskolc, Hungary, 3529
Contact: Study Coordinator    +36304111076      
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0203) Recruiting
Szolnok, Hungary, 5000
Contact: Study Coordinator    +36209323256      
Israel
Barzilai Medical Center ( Site 0226) Recruiting
Ashkelon, Israel, 7830604
Contact: Study Coordinator    +97286745378      
Soroka Medical Center ( Site 0222) Recruiting
Beer Sheva, Israel, 8457108
Contact: Study Coordinator    +972587040620      
Rambam Medical Center ( Site 0223) Recruiting
Haifa, Israel, 3109601
Contact: Study Coordinator    +97248542811      
Meir Medical Center ( Site 0221) Recruiting
Kfar-Saba, Israel, 4428164
Contact: Study Coordinator    +97297472414      
Rabin Medical Center ( Site 0224) Recruiting
Petah Tikva, Israel, 4941492
Contact: Study Coordinator    +97239378101      
Sheba Medical Center ( Site 0220) Recruiting
Ramat Gan, Israel, 5266202
Contact: Study Coordinator    +97235307096      
Sourasky Medical Center ( Site 0225) Recruiting
Tel Aviv, Israel, 6423906
Contact: Study Coordinator    +97236973494      
Italy
Azienda Ospedaliera San Giuseppe Moscati ( Site 0234) Recruiting
Avellino, Italy, 83100
Contact: Study Coordinator    +390825203573      
Centro di Riferimento Oncologico CRO ( Site 0235) Recruiting
Aviano, Italy, 33081
Contact: Study Coordinator    +390434659294      
Universita Magna Grecia ( Site 0230) Recruiting
Catanzaro, Italy, 88100
Contact: Study Coordinator    +393382901571      
A.O. Universitaria Careggi ( Site 0236) Recruiting
Firenze, Italy, 50134
Contact: Study Coordinator    +39557947019      
Ospedale Santa Maria delle Croci ( Site 0232) Recruiting
Ravenna, Italy, 48121
Contact: Study Coordinator    +390544285206      
Policlinico Gemelli di Roma ( Site 0237) Recruiting
Roma, Italy, 00168
Contact: Study Coordinator    +390630154953      
Ospedale San Giovanni Addolorata ( Site 0233) Recruiting
Roma, Italy, 00184
Contact: Study Coordinator    +393294092709      
Presidio Ospedaliero San Vincenzo ( Site 0231) Recruiting
Taormina, Italy, 98039
Contact: Study Coordinator    +390942579412      
Japan
Aichi Cancer Center Hospital ( Site 0018) Recruiting
Nagoya, Aichi, Japan, 464-8681
Contact: Study Coordinator    +81527626111      
Kurume University Hospital ( Site 0025) Recruiting
Kurume, Fukuoka, Japan, 830-0011
Contact: Study Coordinator    +81942353311      
Hyogo Cancer Center ( Site 0021) Recruiting
Akashi, Hyogo, Japan, 673-8558
Contact: Study Coordinator    +81789291151      
Kanagawa Cardiovascular and Respiratory Center ( Site 0026) Recruiting
Yokohama, Kanagawa, Japan, 236-0051
Contact: Study Coordinator    +81457019581      
Kanagawa Cancer Center ( Site 0023) Recruiting
Yokohama, Kanagawa, Japan, 241-8515
Contact: Study Coordinator    +81455202222      
Miyagi Cancer Center ( Site 0028) Recruiting
Natori, Miyagi, Japan, 981-1293
Contact: Study Coordinator    +81223843151      
Sendai Kousei Hospital ( Site 0022) Recruiting
Sendai, Miyagi, Japan, 980-0873
Contact: Study Coordinator    +81222226181      
Kindai University Hospital ( Site 0017) Recruiting
Osakasayama, Osaka, Japan, 589-8511
Contact: Study Coordinator    +81723660221      
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0027) Recruiting
Sakai, Osaka, Japan, 591-8555
Contact: Study Coordinator    +81722523021      
National Hospital Organization Kyushu Medical Center ( Site 0015) Recruiting
Fukuoka, Japan, 810-8563
Contact: Study Coordinator    +81928520700      
Kyushu University Hospital ( Site 0030) Recruiting
Fukuoka, Japan, 812-8582
Contact: Study Coordinator    +81926411151      
Okayama University Hospital ( Site 0020) Recruiting
Okayama, Japan, 700-8558
Contact: Study Coordinator    +81862237151      
Osaka International Cancer Institute ( Site 0019) Recruiting
Osaka, Japan, 541-8567
Contact: Study Coordinator    +81669451181      
Toranomon Hospital ( Site 0016) Recruiting
Tokyo, Japan, 105-8470
Contact: Study Coordinator    +81335881111      
Juntendo University Hospital ( Site 0029) Recruiting
Tokyo, Japan, 113-8431
Contact: Study Coordinator    +81338133111      
Nippon Medical School Hospital ( Site 0024) Recruiting
Tokyo, Japan, 113-8603
Contact: Study Coordinator    +81338222131      
Korea, Republic of
Chungbuk National University Hospital ( Site 0079) Recruiting
Cheongju si, Chungcheongbuk Do, Korea, Republic of, 28644
Contact: Study Coordinator    +82432696015      
Seoul National University Bundang Hospital ( Site 0075) Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Study Coordinator    +82317877039      
Asan Medical Center ( Site 0076) Recruiting
Seoul, Korea, Republic of, 05505
Contact: Study Coordinator    +82230103215      
SMG-SNU Boramae Medical Center ( Site 0078) Recruiting
Seoul, Korea, Republic of, 07061
Contact: Study Coordinator    +8228703202      
Ulsan University Hospital ( Site 0077) Recruiting
Ulsan, Korea, Republic of, 44033
Contact: Study Coordinator    +82522508832      
Malaysia
Hospital Tengku Ampuan Afzan ( Site 0062) Recruiting
Kuantan, Pahang Darul Makmar, Malaysia, 25100
Contact: Study Coordinator    +6095572923      
Hospital Pulau Pinang. ( Site 0065) Recruiting
Georgetown, Pulau Pinang, Malaysia, 11200
Contact: Study Coordinator    +6042225209      
Sarawak General Hospital ( Site 0064) Recruiting
Kuching, Sarawak, Malaysia, 93586
Contact: Study Coordinator    +60109827539      
Beacon Hospital Sdn Bhd ( Site 0067) Recruiting
Petaling Jaya, Selangor, Malaysia, 46050
Contact: Study Coordinator    +60376207979      
Institut Kanser Negara - National Cancer Institute ( Site 0063) Recruiting
Putrajaya, Wilayah Persekutuan, Malaysia, 62250
Contact: Study Coordinator    +60388925555      
University Malaya Medical Centre ( Site 0061) Recruiting
Kuala Lumpur, Malaysia, 59100
Contact: Study Coordinator    +60124553116      
Gleneagles Penang ( Site 0066) Recruiting
Pulau Pinang, Malaysia, 10050
Contact: Study Coordinator    +6042285760      
Mexico
Consultorios de Medicina Especializada del Sector Privado ( Site 0388) Recruiting
Guadalajara, Jalisco, Mexico, 44680
Contact: Study Coordinator    +523313141707      
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 0381) Recruiting
Madero, Tamaulipas, Mexico, 89440
Contact: Study Coordinator    +528332142554      
Oaxaca Site Management Organization SC ( Site 0389) Recruiting
Oaxaca, Mexico, 68000
Contact: Study Coordinator    +529515147056      
Poland
Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 0253) Recruiting
Krakow, Malopolskie, Poland, 31-202
Contact: Study Coordinator    +48506153255      
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0243) Recruiting
Krakow, Poland, 31-826
Contact: Study Coordinator    +48126468634      
SPZOZ USK nr 1 im. Norberta Barlickiego UM w Lodzi ( Site 0256) Recruiting
Lodz, Poland, 99-153
Contact: Study Coordinator    +48426787505      
Centrum Medyczne Pratia Ostroleka ( Site 0242) Recruiting
Ostroleka, Poland, 07-410
Contact: Study Coordinator    +48297652827      
Ars Medical Sp. z o.o. ( Site 0254) Recruiting
Pila, Poland, 64-920
Contact: Study Coordinator    +48601261207      
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0250) Recruiting
Przemysl, Poland, 37-700
Contact: Study Coordinator    +48166775510      
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie ( Site 0252) Recruiting
Warszawa, Poland, 02-781
Contact: Study Coordinator    +48225463066      
Szpital Uniwersytecki im. Karola Marcinkowskiego ( Site 0247) Recruiting
Zielona Gora, Poland, 65-046
Contact: Study Coordinator    +48683296527      
Russian Federation
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0266) Recruiting
Krasnoyarsk, Russian Federation, 644013
Contact: Study Coordinator    +79135349316      
SBHI Leningrad Regional Clinical Hospital ( Site 0263) Recruiting
Saint Petersburg, Russian Federation, 194291
Contact: Study Coordinator    +79219075211      
Railway Hospital of OJSC ( Site 0268) Recruiting
Saint Petersburg, Russian Federation, 195271
Contact: Study Coordinator    +79052154918      
City Clinical Oncology Center ( Site 0260) Recruiting
Saint Petersburg, Russian Federation, 198255
Contact: Study Coordinator    +78127569923      
SBHI Samara Regional Clinical Oncology Dispensary ( Site 0265) Recruiting
Samara, Russian Federation, 443031
Contact: Study Coordinator    +79272143459      
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0262) Recruiting
Ufa, Russian Federation, 450054
Contact: Study Coordinator    +73472485518      
Taiwan
National Taiwan University Hospital Hsin-Chu Branch ( Site 0087) Recruiting
Hsinchu, Taiwan, 300
Contact: Study Coordinator    +886223368239      
Taipei Medical University Shuang Ho Hospital ( Site 0090) Recruiting
New Taipei, Taiwan, 235
Contact: Study Coordinator    +886222490088      
National Cheng Kung University Hospital ( Site 0086) Recruiting
Tainan, Taiwan, 70457
Contact: Study Coordinator    +886623535354559      
National Taiwan University Hospital ( Site 0088) Recruiting
Taipei, Taiwan, 10002
Contact: Study Coordinator    +88622312345667511      
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0091) Recruiting
Taipei, Taiwan, 11259
Contact: Study Coordinator    +8862289700111686      
Taipei Veterans General Hospital ( Site 0089) Recruiting
Taipei, Taiwan, 112
Contact: Study Coordinator    +8862287121212340      
Turkey
Gulhane Egitim ve Arastirma Hastanesi ( Site 0316) Recruiting
Ankara, Turkey, 06010
Contact: Study Coordinator    +905366401020      
Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0318) Recruiting
Ankara, Turkey, 06200
Contact: Study Coordinator    +905055718475      
Baskent Universitesi Ankara Hastanesi ( Site 0319) Recruiting
Ankara, Turkey, 06490
Contact: Study Coordinator    +905333414050      
Antalya Memorial Hospital Department of Medical Oncology ( Site 0324) Recruiting
Antalya, Turkey, 07020
Contact: Study Coordinator    +905336107312      
Akdeniz Universitesi Tip Fakultesi ( Site 0322) Recruiting
Antalya, Turkey, 07070
Contact: Study Coordinator    +905557606050      
Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0314) Recruiting
Izmir, Turkey, 35340
Contact: Study Coordinator    +605426351233      
Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0321) Recruiting
Konya, Turkey, 42080
Contact: Study Coordinator    +905322679838      
Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 0323) Recruiting
Sakarya, Turkey, 54290
Contact: Study Coordinator    +905052014666      
Samsun Medical Park Hastanesi ( Site 0320) Recruiting
Samsun, Turkey, 55200
Contact: Study Coordinator    +905364247616      
Ukraine
Cherkasy Regional Hospital ( Site 0336) Recruiting
Cherkasy, Ukraine, 18009
Contact: Study Coordinator    +380501606360      
City Clinical Hosp.4 of DCC ( Site 0338) Recruiting
Dnipropetrovsk, Ukraine, 49102
Contact: Study Coordinator    +380675625054      
MI Precarpathian Clinical Oncology Center ( Site 0346) Recruiting
Ivano-Frankivsk, Ukraine, 76018
Contact: Study Coordinator    +380978411455      
Communal non profit enterprise Regional Clinical Oncology Center ( Site 0337) Recruiting
Kharkiv, Ukraine, 61070
Contact: Study Coordinator    +380503802915      
Ukranian Center of TomoTherapy ( Site 0344) Recruiting
Kropyvnytskiy, Ukraine, 25011
Contact: Study Coordinator    +380979428527      
Medical Center Verum ( Site 0334) Recruiting
Kyiv, Ukraine, 03039
Contact: Study Coordinator    380997799214      
Kyiv City Clinical Oncology Centre ( Site 0339) Recruiting
Kyiv, Ukraine, 03115
Contact: Study Coordinator    +380503818536      
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 0331) Recruiting
Kyiv, Ukraine, 03126
Contact: Study Coordinator    +380503481865      
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0341) Recruiting
Lviv, Ukraine, 79031
Contact: Study Coordinator    +380505136507      
MI Odessa Regional Oncological Centre ( Site 0333) Recruiting
Odesa, Ukraine, 65055
Contact: Study Coordinator    +380504261911      
Podillya Regional Center of Oncology ( Site 0343) Recruiting
Vinnytsia, Ukraine, 21029
Contact: Study Coordinator    380975791841      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Eisai Inc.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

Additional Information:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03829332    
Other Study ID Numbers: 7902-007
MK-7902-007 ( Other Identifier: Merck Protocol Number )
E7080-G000-314 ( Other Identifier: Eisai Protocol Number )
LEAP-007 ( Other Identifier: Merck )
2018-003794-98 ( EudraCT Number )
194670 ( Registry Identifier: JAPIC-CTI )
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme Corp.:
programmed cell death 1 (PD-1, PD1)
programmed cell death-ligand 1 (PD-L1, PDL1)
programmed cell death-ligand 2 (PD-L2, PDL2)
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Bronchial Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Pembrolizumab
Lenvatinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action