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Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789)

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: NCT03515837
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib [TAGRISSO®] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status.

The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS.


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Biological: pembrolizumab Drug: pemetrexed Drug: carboplatin Drug: cisplatin Drug: saline solution Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Phase 3 Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in TKI-resistant EGFR-mutated Tumors in Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Participants (KEYNOTE-789)
Actual Study Start Date : June 29, 2018
Estimated Primary Completion Date : June 15, 2023
Estimated Study Completion Date : June 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Pembro+Pemetrexed+Chemo
Participants receive pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W with no restrictions on the number of cycles PLUS platinum chemotherapy (chemo) (either carboplatin Area Under the Curve [AUC] 5 via IV infusion Q3W for 4 cycles [Cycles 1-4] or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles [Cycles 1-4]).
Biological: pembrolizumab
IV infusion
Other Name: MK-3475

Drug: pemetrexed
IV infusion

Drug: carboplatin
IV infusion

Drug: cisplatin
IV infusion

Active Comparator: Placebo+Pemetrexed+Chemo
Participants receive normal saline solution via IV infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W with no restrictions on the number of cycles PLUS platinum chemotherapy (chemo)(either carboplatin AUC 5 via IV infusion Q3W for 4 cycles [Cycles 1-4] or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles [Cycles 1-4]).
Drug: pemetrexed
IV infusion

Drug: carboplatin
IV infusion

Drug: cisplatin
IV infusion

Drug: saline solution
IV infusion
Other Name: Normal saline solution




Primary Outcome Measures :
  1. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 32 months ]
    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PFS will be assessed by blinded independent central review (BICR) using RECIST 1.1. Per RECIST 1.1, PD is defined as at least a 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 at least 5 mm. Note: The appearance of one or more new lesions is also considered PD. The PFS for participants will be presented.

  2. Overall Survival (OS) [ Time Frame: Up to approximately 59 months ]
    OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis will be censored at the date of the last follow-up. The OS of participants will be presented.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) Per RECIST 1.1 [ Time Frame: Up to approximately 32 months ]
    ORR is defined as the percentage of participants in the analysis population who experience 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, taking as reference the baseline sum diameters) per RECIST 1.1. The ORR for participants will be presented.

  2. Duration of Response (DOR) Per RECIST 1.1 [ Time Frame: Up to approximately 32 months ]
    For participants who experience a response of CR or PR, DOR is defined as the time from the earliest date of qualifying response until earliest date of PD or death from any cause, whichever comes first. DOR will be assessed per RECIST 1.1 based on BICR. The DOR of participants who experience a CR or PR will be presented.

  3. Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 Item (QLQ-C30) Global Health Status (Item 29) Scale Score [ Time Frame: Baseline and Week 12, Week 27 ]
    The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. For Global Health Status, participants are asked "How would you rate your overall health during the past week?" Individual responses are given on a 7-point scale (1=Very poor; 7=Excellent), with a higher score indicating a better outcome. The change from baseline in EORTC-QLQ-C30 score for Global Health Status will be presented.

  4. Time to True Deterioration (TTD) in the EORTC Questionnaire Composite Endpoint of Cough, Chest Pain or Dyspnea [ Time Frame: Up to approximately 32 months ]
    TTD is the time from baseline to first onset of 10 points or more decrease from baseline with confirmation by the subsequent visit of 10 points or more deterioration from baseline in the composite endpoint of cough [EORTC QLQ-Lung Cancer Module 13 (LC13) Item 1; How much did you cough?], chest pain [EORTC QLQ-LC13 Item 10; Have you had pain in your chest?], or dyspnea [EORTC QLQ-C30 Item 8; Were you short of breath?]. Individual responses are given on a 4-point scale (1=Not at all; 4=Very much), with a lower score indicating a better outcome. The time to true deterioration in the composite endpoint of cough, chest pain or dyspnea will be presented.

  5. Adverse Events (AEs) [ Time Frame: Up to 90 days after last dose of study treatment (Up to approximately 42 months) ]
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who experience an AE will be presented.

  6. Study Treatment Discontinuations Due to AEs [ Time Frame: Up to approximately 39 months ]
    The number of participants who discontinue study treatment due to an AE will be presented.

  7. Change from Baseline in EORTC-QLQ-C30 Quality of Life (Item 30) Scale Score [ Time Frame: Baseline and Week 12, Week 27 ]
    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. For Quality of Life, participants are asked "How would you rate your overall quality of life during the past week?" Individual responses are given on a 7-point scale (1=Very poor; 7=Excellent), with a higher score indicating a better outcome. The change from baseline in EORTC-QLQ-C30 score for Quality of Life 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.


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

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of Stage IV non-squamous NSCLC.
  • Documentation of tumor activating EGFR mutation, specifically either DEL19 or L858R.
  • Investigator-determined radiographic disease progression per RECIST 1.1 after treatment with an EGFR TKI therapy: a) Participants previously treated with 1st or 2nd generation EGFR TKI (e.g. erlotinib/afatinib/gefitinib) are required to have confirmed documented absence of EGFR T790M mutation; b) Participants with confirmed acquired T790M mutation after 1st or 2nd generation EGFR TKI (e.g. erlotinib/afatinib/gefitinib) are required to have osimertinib TKI treatment failure prior to enrollment; c) Participants previously failed osimertinib TKI treatment as 1st line therapy are eligible regardless of their EGFR T790M mutation status. Note: TKI washout period for all participants is 1 week or 2 half-lives after last treatment dose, whichever is longer. TKI washout should be completed prior to first dose of study treatment.
  • Measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.
  • Provided archival tumor tissue sample or newly obtained (no anti-neoplastic therapy since biopsy) core or excisional biopsy of a tumor lesion not previously irradiated.
  • Life expectancy of at least 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of study treatment but before randomization.
  • Male participants must agree to use contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab and up to 180 days after last dose of chemotherapeutic agents.
  • Female participants must not be pregnant, not breastfeeding, and must agree to use contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab and up to 180 days after the last dose of chemotherapeutic agents.
  • Adequate organ function.

Exclusion Criteria:

  • Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible.
  • Symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
  • Received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 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], OX-40, CD137).
  • Received prior systemic cytotoxic chemotherapy or investigational agent(s), excluding EGFR TKIs, for metastatic NSCLC. [Notes: 1) Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic NSCLC. 2) If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment. 3) Prior exposure to traditional medicine(s) is allowed as long as therapy was discontinued at least 4 weeks prior to the first dose of study treatment.]
  • Received prior radiotherapy within 2 weeks of start of study treatment or has received lung radiation therapy of >30 Gray (Gy) within 6 months before the first dose of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
  • Received a live vaccine within 30 days prior to the first dose of study treatment.
  • Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment.
  • Known additional malignancy that is progressing or has required active treatment within the past 5 years. (Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.)
  • Known active untreated CNS metastases and/or carcinomatous meningitis.
  • Severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
  • Known sensitivity to any component of cisplatin, carboplatin, or pemetrexed.
  • Active autoimmune disease that has required systemic treatment in past 2 years.
  • History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Active infection requiring systemic therapy.
  • Known history of human immunodeficiency virus (HIV) infection.
  • Known history of Hepatitis B or known active Hepatitis C virus.
  • Known history of active tuberculosis (TB; Bacillus tuberculosis)
  • Pregnant, 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 pembrolizumab and up to 180 days after the last dose of chemotherapeutic agents.

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): NCT03515837


Contacts
Layout table for location contacts
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

  Hide Study Locations
Locations
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United States, California
Pacific Cancer Care ( Site 0058) Recruiting
Monterey, California, United States, 93940
Contact: Study Coordinator    831-375-4105      
UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0092) Recruiting
Orange, California, United States, 92868
Contact: Study Coordinator    714-456-5153      
St. Joseph Heritage Healthcare ( Site 0003) Recruiting
Santa Rosa, California, United States, 95403
Contact: Study Coordinator    707-521-3830      
United States, Illinois
North Shore University Health System ( Site 0030) Recruiting
Evanston, Illinois, United States, 60201
Contact: Study Coordinator    847-570-2109      
United States, Iowa
Siouxland Regioinal Cancer Center dba June E. Nylen Cancer Center ( Site 0065) Recruiting
Sioux City, Iowa, United States, 51101
Contact: Study Coordinator    712-252-9358      
United States, Minnesota
Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 0048) Recruiting
Edina, Minnesota, United States, 55435
Contact: Study Coordinator    612-672-5233      
United States, Missouri
Saint Lukes Hospital of Kansas City ( Site 0060) Recruiting
Kansas City, Missouri, United States, 64111
Contact: Study Coordinator    816-932-1370      
United States, New York
New York Oncology Hematology P.C ( Site 8000) Recruiting
Albany, New York, United States, 12208
Contact: Study Coordinator    214-336-3364      
Monter Cancer Center ( Site 0054) Recruiting
Lake Success, New York, United States, 11042
Contact: Study Coordinator    516-743-8248      
Memorial Sloan Kettering Cancer Center-Rockerfeller Patient Pavilion ( Site 0049) Recruiting
New York, New York, United States, 10022
Contact: Study Coordinator    646-574-3798      
White Plains Hospital Center for Cancer Care ( Site 0014) Recruiting
White Plains, New York, United States, 10601
Contact: Study Coordinator    914-849-7582      
United States, Oregon
Providence Oncology and Hematology, Care Clinic - Eastside ( Site 0097) Recruiting
Portland, Oregon, United States, 97213
Contact: Study Coordinator    503-215-2614      
Kaiser Permanente Northwest ( Site 0037) Recruiting
Portland, Oregon, United States, 97227
Contact: Study Coordinator    503-249-6537      
United States, Texas
Parkland Health & Hospital System ( Site 2102) Recruiting
Dallas, Texas, United States, 75235
Contact: Study Coordinator    214-648-1688      
University of Texas Southwestern Medical Center at Dallas ( Site 0035) Recruiting
Dallas, Texas, United States, 75390
Contact: Study Coordinator    214-648-1688      
United States, Utah
Utah Cancer Specialists ( Site 0001) Recruiting
Salt Lake City, Utah, United States, 84106
Contact: Study Coordinator    801-281-6864      
United States, Virginia
Emily Couric Clinical Cancer Center ( Site 0020) Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Study Coordinator    434-297-7784      
United States, Wisconsin
Froedtert Hospital & the Medical College of Wisconsin ( Site 0041) Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Study Coordinator    414-805-4600      
Australia, New South Wales
Chris OBrien Lifehouse ( Site 0200) Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Study Coordinator    +61285140922      
Australia, Victoria
Eastern Health ( Site 0202) Recruiting
Box Hill, Victoria, Australia, 3128
Contact: Study Coordinator    +61398953585      
Austin Health ( Site 0203) Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Study Coordinator    +61394963702      
Australia
Westmead Hospital ( Site 0201) Recruiting
Westmead, Australia, 2145
Contact: Study Coordinator    +61298455200      
Brazil
Hospital de Caridade de Ijui ( Site 1907) Recruiting
Ijui, RS, Brazil, 98700-000
Contact: Study Coordinator    +555533319393      
Hospital Bruno Born ( Site 1913) Recruiting
Lajeado, RS, Brazil, 95900-010
Contact: Study Coordinator    +5551998487266      
Hospital de Clinicas de Porto Alegre ( Site 1905) Recruiting
Porto Alegre, RS, Brazil, 90035-903
Contact: Study Coordinator    +555133203039      
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1904) Recruiting
Porto Alegre, RS, Brazil, 90610-000
Contact: Study Coordinator    +555133203039      
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1911) Recruiting
Barretos, Brazil, 14784-400
Contact: Study Coordinator    +551733216638      
Liga Norte Riograndense Contra o Cancer ( Site 1909) Recruiting
Natal, Brazil, 59075-740
Contact: Study Coordinator    +558440095595      
Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1912) Recruiting
Ribeirao Preto, Brazil, 14048-900
Contact: Study Coordinator    +5516991036202      
Instituto do Cancer de Sao Paulo - ICESP ( Site 1903) Recruiting
Sao Paulo, Brazil, 01246-000
Contact: Study Coordinator    +551138932615      
Canada, Ontario
William Osler Health System ( Site 0100) Recruiting
Brampton, Ontario, Canada, L6R 3J7
Contact: Study Coordinator    905494212057263      
Sunnybrook Health Sciences, Odette Cancer Centre ( Site 0102) Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Study Coordinator    41648050007955      
Princess Margaret Cancer Centre ( Site 0104) Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Study Coordinator    4169462913      
Canada, Quebec
Jewish General Hospital ( Site 0105) Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Study Coordinator    +514340822223674      
China, Anhui
The First Affiliated Hospital of Anhui Medical University ( Site 0721) Recruiting
Hefei, Anhui, China, 230088
Contact: Study Coordinator    +8613956012561      
China, Fujian
Fujian Cancer Hospital ( Site 0723) Recruiting
Fuzhou, Fujian, China, 350014
Contact: Study Coordinator    +8613905010379      
China, Heilongjiang
The Affiliated Tumour Hospital of Harbin Medical University ( Site 0706) Recruiting
Harbin, Heilongjiang, China, 150081
Contact: Study Coordinator    +8613313636333      
China, Henan
Henan Cancer Hospital ( Site 0711) Recruiting
Zhengzhou, Henan, China, 450008
Contact: Study Coordinator    +86037165587421      
China, Hunan
Xiangya Hospital of Central South University ( Site 0710) Recruiting
Changsha, Hunan, China, 410008
Contact: Study Coordinator    +86073184328888      
Hunan Cancer Hospital ( Site 0722) Recruiting
Changsha, Hunan, China, 410013
Contact: Study Coordinator    +8613170419973      
Zhongshan Hospital Fudan University ( Site 0712) Recruiting
Shanghai, Hunan, China, 200032
Contact: Study Coordinator    +8613681975806      
China, Jiangsu
Jiangsu Cancer Hospital ( Site 0719) Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Study Coordinator    +8613901581264      
China, Jilin
The First Hospital of Jilin University ( Site 0702) Recruiting
Chang chun, Jilin, China, 130021
Contact: Study Coordinator    43188783373      
Jilin Cancer Hospital ( Site 0705) Recruiting
Changchun, Jilin, China, 130012
Contact: Study Coordinator    43185879120      
China, Shanxi
Tangdu Hospital ( Site 0708) Recruiting
XI An, Shanxi, China, 710038
Contact: Study Coordinator    +862984777455      
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0709) Recruiting
XI An, Shanxi, China, 710061
Contact: Study Coordinator    +8613572101611      
China, Sichuan
Southwest Hospital, The Third Military Medical University ( Site 0725) Recruiting
Chongqing, Sichuan, China, 400038
Contact: Study Coordinator    +8613708349632      
China, Xinjiang
Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0701) Recruiting
Urumqi, Xinjiang, China, 830000
Contact: Study Coordinator    +8618699116664      
China, Zhejiang
The First Affiliated Hospital.Zhejiang University ( Site 0713) Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Study Coordinator    8613505719970      
Sir Run Run Shaw Hospital School of Medicine, Zhejiang University ( Site 0715) Recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Study Coordinator    +8613588706900      
Zhejiang Cancer Hospital ( Site 0716) Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Study Coordinator    +8613858182310      
China
Cancer Hospital Chinese Academy of Medical Sciences ( Site 0717) Recruiting
Beijing, China, 100021
Contact: Study Coordinator    13911793771      
Peking Union Medical College Hospital ( Site 0703) Recruiting
Beijing, China, 100032
Contact: Study Coordinator    +8669156114      
Beijing Cancer Hospital ( Site 0718) Recruiting
Beijing, China, 100036
Contact: Study Coordinator    +8613301212676      
Shanghai Chest Hospital ( Site 0700) Recruiting
Shanghai, China, 200030
Contact: Study Coordinator    +8602122200000      
France
Hopital Prive d'Antony ( Site 0811) Recruiting
Antony, France, 92160
Contact: Study Coordinator    +33146744173      
Hopital Jean Minjoz Besancon ( Site 0805) Recruiting
Besancon, France, 25030
Contact: Study Coordinator    +33370632440      
CHU Caen Service de Pneumologie ( Site 0804) Recruiting
Caen, France, 14033
Contact: Study Coordinator    +33231064676      
Centre Georges Francois Leclerc ( Site 0809) Recruiting
Dijon, France, 21000
Contact: Study Coordinator    +33380737528      
Clinique Victor Hugo ( Site 0802) Recruiting
Le Mans, France, 72000
Contact: Study Coordinator    +33243399493      
Centre Leon Berard ( Site 0801) Recruiting
Lyon, France, 69008
Contact: Study Coordinator    +33478785107      
Centre D Oncologie de Gentilly ( Site 0810) Recruiting
Nancy, France, 54100
Contact: Study Coordinator    +33383935005      
CHU Poitiers ( Site 0803) Recruiting
Poitiers, France, 86021
Contact: Study Coordinator    +33549444538      
C.H.U. de Tours - Hopital Bretonneau ( Site 0806) Recruiting
Tours, France, 37044
Contact: Study Coordinator    +33247474747      
Germany
Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0907) Recruiting
Dresden, Germany, 01307
Contact: Study Coordinator    +493514587666      
Kliniken Essen-Mitte ( Site 0900) Recruiting
Essen, Germany, 45136
Contact: Study Coordinator    +4920117424001      
Robert Bosch Krankenhaus Klinik Schillerhoehe ( Site 0904) Recruiting
Gerlingen, Germany, 70839
Contact: Study Coordinator    +4971562032772      
Asklepios Klinikum Hamburg ( Site 0908) Recruiting
Hamburg, Germany, 21075
Contact: Study Coordinator    +49401818865008      
Universitaetsklinikum Mannheim ( Site 0911) Recruiting
Mannheim, Germany, 68167
Contact: Study Coordinator    +496213832855      
Universitaetsklinikum Muenster ( Site 0906) Recruiting
Muenster, Germany, 48149
Contact: Study Coordinator    +492518344803      
Pius Hospital Oldenburg ( Site 0905) Recruiting
Oldenburg, Germany, 26121
Contact: Study Coordinator    +494412291611      
Klinikum Wuerzburg Mitte gGmbH ( Site 0901) Recruiting
Wuerzburg, Germany, 97074
Contact: Study Coordinator    +499317912811      
Hong Kong
Hong Kong Integrated Oncology Centre ( Site 0304) Recruiting
Hong Kong, Hong Kong
Contact: Study Coordinator    +85237006888      
Queen Mary Hospital ( Site 0301) Recruiting
Hong Kong, Hong Kong
Contact: Study Coordinator    +85222554352      
Queen Mary Hospital ( Site 0303) Recruiting
Hong Kong, Hong Kong
Contact: Study Coordinator    +85222554999      
Tuen Mun Hospital ( Site 0305) Recruiting
Tuen Mun, Hong Kong
Contact: Study Coordinator    +85224685092      
Israel
Barzilai Medical Center ( Site 1706) Recruiting
Ashkelon, Israel, 7830604
Contact: Study Coordinator    +97286745378      
Soroka Medical Center ( Site 1702) Recruiting
Beer-Sheva, Israel, 8457108
Contact: Study Coordinator    +972587040620      
Rambam Medical Center ( Site 1703) Recruiting
Haifa, Israel, 3109601
Contact: Study Coordinator    +97247776734      
Meir Medical Center ( Site 1701) Recruiting
Kfar-Saba, Israel, 4428164
Contact: Study Coordinator    +97297472414      
Rabin Medical Center ( Site 1704) Recruiting
Petah Tikva, Israel, 4941492
Contact: Study Coordinator    +97239378101      
Chaim Sheba Medical Center. ( Site 1700) Recruiting
Ramat Gan, Israel, 5265601
Contact: Study Coordinator    +97235307096      
Sourasky Medical Center ( Site 1705) Completed
Tel Aviv, Israel, 6423906
Italy
AOU San Luigi Gonzaga di Orbassano ( Site 1300) Recruiting
Orbassano, Torino, Italy, 10043
Contact: Study Coordinator    +390119026322      
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1305) Recruiting
Bari, Italy, 70124
Contact: Study Coordinator    +390805555418      
Azienda Ospedaliero Universitaria Careggi ( Site 1301) Recruiting
Firenze, Italy, 50134
Contact: Study Coordinator    +390557949185      
Istituto Europeo di Oncologia ( Site 1303) Recruiting
Milano, Italy, 20141
Contact: Study Coordinator    +390257489440      
Azienda Ospedaliera dei Colli V. Monaldi ( Site 1306) Recruiting
Napoli, Italy, 80131
Contact: Study Coordinator    +390817065213      
Universita Campus Bio-Medico di Roma ( Site 1304) Recruiting
Roma, Italy, 00128
Contact: Study Coordinator    +3906225411227      
Ospedale San Vincenzo di Taormina ( Site 1302) Recruiting
Taormina, Italy, 98039
Contact: Study Coordinator    +390942579322      
Japan
National Hospital Organization Nagoya Medical Center ( Site 0608) Recruiting
Nagoya, Aichi, Japan, 460-0001
Contact: Study Coordinator    +81529511111      
Aichi Cancer Center Hospital ( Site 0612) Recruiting
Nagoya, Aichi, Japan, 464-8681
Contact: Study Coordinator    +81527626111      
Fujita Health University Hospital ( Site 0619) Recruiting
Toyoake, Aichi, Japan, 470-1192
Contact: Study Coordinator    +81562932111      
National Cancer Center Hospital East ( Site 0601) Recruiting
Kashiwa, Chiba, Japan, 277-8577
Contact: Study Coordinator    +81471331111      
National Hospital Organization Shikoku Cancer Center ( Site 0616) Recruiting
Matsuyama, Ehime, Japan, 791-0280
Contact: Study Coordinator    +81899991111      
Hyogo Cancer Center ( Site 0604) Recruiting
Akashi, Hyogo, Japan, 673-8558
Contact: Study Coordinator    +81789291151      
Kanazawa University Hospital ( Site 0617) Recruiting
Kanazawa, Ishikawa, Japan, 920-8641
Contact: Study Coordinator    +81762652000      
Kanagawa Cancer Center ( Site 0609) Recruiting
Yokohama, Kanagawa, Japan, 241-8515
Contact: Study Coordinator    +81455202222      
Kansai Medical University Hospital ( Site 0606) Recruiting
Hirakata, Osaka, Japan, 573-1191
Contact: Study Coordinator    +81728040101      
Shizuoka Cancer Center Hospital and Research Institute ( Site 0602) Recruiting
Sunto-gun, Shizuoka, Japan, 411-8777
Contact: Study Coordinator    +81559895222      
National Hospital Organization Kyushu Medical Center ( Site 0621) Recruiting
Fukuoka, Japan, 810-8563
Contact: Study Coordinator    +81928520700      
Kyushu University Hospital ( Site 0605) Recruiting
Fukuoka, Japan, 812-8582
Contact: Study Coordinator    +81926411151      
Niigata Cancer Center Hospital ( Site 0610) Recruiting
Niigata, Japan, 951-8566
Contact: Study Coordinator    +81252665111      
Okayama University Hospital ( Site 0614) Recruiting
Okayama, Japan, 700-8558
Contact: Study Coordinator    +81862237151      
Osaka International Cancer Institute ( Site 0611) Recruiting
Osaka, Japan, 541-8567
Contact: Study Coordinator    +81669451181      
National Cancer Center Hospital ( Site 0603) Recruiting
Tokyo, Japan, 104-0045
Contact: Study Coordinator    +81335422511      
Toranomon Hospital ( Site 0615) Recruiting
Tokyo, Japan, 105-8470
Contact: Study Coordinator    +81335881111      
Tokyo Metropolitan Komagome Hospital ( Site 0618) Recruiting
Tokyo, Japan, 113-8677
Contact: Study Coordinator    +81338232101      
Wakayama Medical University Hospital ( Site 0613) Recruiting
Wakayama, Japan, 641-8510
Contact: Study Coordinator    +81734472300      
Korea, Republic of
Chungbuk National University Hospital ( Site 0404) Recruiting
Cheongju si, Chungcheongbuk Do, Korea, Republic of, 28644
Contact: Study Coordinator    +82432696015      
Seoul National University Bundang Hospital ( Site 0405) Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Study Coordinator    +82317877003      
National Cancer Center ( Site 0400) Recruiting
Gyeonggi-do, Korea, Republic of, 10408
Contact: Study Coordinator    +82319201154      
Gachon University Gil Medical Center ( Site 0408) Recruiting
Incheon, Korea, Republic of, 21565
Contact: Study Coordinator    +82324602628      
Seoul National University Hospital ( Site 0402) Recruiting
Seoul, Korea, Republic of, 03080
Contact: Study Coordinator    +82220722995      
Asan Medical Center ( Site 0407) Recruiting
Seoul, Korea, Republic of, 05505
Contact: Study Coordinator    +82230103214      
Samsung Medical Center ( Site 0403) Recruiting
Seoul, Korea, Republic of, 06351
Contact: Study Coordinator    +82234103459      
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0406) Recruiting
Seoul, Korea, Republic of, 06591
Contact: Study Coordinator    +82222586043      
Ulsan University Hospital ( Site 0401) Recruiting
Ulsan, Korea, Republic of, 44033
Contact: Study Coordinator    +82522508832      
Mexico
Instituto Nacional de Cancerologia. ( Site 2007) Recruiting
Tlalpan, Ciudad De Mexico, Mexico, 14080
Contact: Study Coordinator    +525513150894      
Instituto Jaliscience de Cancerologia ( Site 2000) Recruiting
Guadalajara, Mexico, 44280
Contact: Study Coordinator    +5213313141707      
Medica Sur S.A.B de C.V. ( Site 2003) Recruiting
Mexico City, Mexico, 14050
Contact: Study Coordinator    +525554247282      
Oaxaca Site Management Organization SC ( Site 2001) Recruiting
Oaxaca, Mexico, 68000
Contact: Study Coordinator    +529515147056      
Spain
Hospitalo Univ. Germans Trias i Pujol ( Site 1100) Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Study Coordinator    +34934978925      
Hospital de la Santa Creu i Sant Pau ( Site 1102) Recruiting
Barcelona, Spain, 08025
Contact: Study Coordinator    +34935565638      
Hospital Universitari Vall d Hebron ( Site 1106) Recruiting
Barcelona, Spain, 08035
Contact: Study Coordinator    +34932746085      
Hospital Ramon y Cajal ( Site 1101) Recruiting
Madrid, Spain, 28034
Contact: Study Coordinator    +34913368263      
Hospital Universitario 12 de Octubre ( Site 1103) Recruiting
Madrid, Spain, 28041
Contact: Study Coordinator    +34913908923      
Complejo Hospitalario Carlos Haya de Malaga ( Site 1107) Recruiting
Malaga, Spain, 29010
Contact: Study Coordinator    +349422033350000      
Hospital Universitario Virgen Macarena ( Site 1104) Recruiting
Sevilla, Spain, 41009
Contact: Study Coordinator    +34955926578      
Sweden
Sahlgrenska Universitetssjukhuset ( Site 1502) Recruiting
Goteborg, Sweden, 413 45
Contact: Study Coordinator    +46313423354      
Linkopings Universitetssjukhus ( Site 1504) Recruiting
Linkoping, Sweden, 581 85
Contact: Study Coordinator    +46731588660      
Skanes Universitetssjukhus Lund ( Site 1503) Recruiting
Lund, Sweden, 221 85
Contact: Study Coordinator    +46707732564      
Karolinska Universitetssjukhuset Solna ( Site 1500) Recruiting
Solna, Sweden, 171 64
Contact: Study Coordinator    +46725721111      
Taiwan
Changhua Christian Hospital ( Site 0509) Recruiting
Changhua, Taiwan, 50006
Contact: Study Coordinator    +886472385953934      
National Taiwan University Hospital Hsin-Chu Branch ( Site 0511) Recruiting
Hsinchu, Taiwan, 300
Contact: Study Coordinator    +88635326151      
Hualien Tzu Chi Medical Center-Hospital ( Site 0510) Recruiting
Hualien, Taiwan, 970
Contact: Study Coordinator    +88638561825      
Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F. ( Site 0507) Recruiting
Kaohsiung, Taiwan, 833
Contact: Study Coordinator    +886773171238199      
Taipei Tzu Chi Hospital ( Site 0512) Recruiting
New Taipei City, Taiwan, 231
Contact: Study Coordinator    +886266289779      
Taipei Medical University Shuang Ho Hospital ( Site 0508) Recruiting
New Taipei, Taiwan, 235
Contact: Study Coordinator    +8862224900882714      
China Medical University Hospital ( Site 0505) Recruiting
Taichung, Taiwan, 40447
Contact: Study Coordinator    +8864220621211212      
Taichung Veterans General Hospital ( Site 0504) Recruiting
Taichung, Taiwan, 407
Contact: Study Coordinator    8864235925253255      
National Cheng Kung University Hospital ( Site 0506) Recruiting
Tainan, Taiwan, 704
Contact: Study Coordinator    +886623535354289      
National Taiwan University Hospital ( Site 0500) Recruiting
Taipei, Taiwan, 100
Contact: Study Coordinator    +886223123456      
Mackay Memorial Hospital ( Site 0503) Recruiting
Taipei, Taiwan, 104
Contact: Study Coordinator    +88625433535      
Taipei Veterans General Hospital ( Site 0501) Recruiting
Taipei, Taiwan, 11217
Contact: Study Coordinator    +8862287121212340      
Chang Gung Medical Foundation. Linkou ( Site 0502) Recruiting
Taoyuan, Taiwan, 333
Contact: Study Coordinator    +886332812008468      
United Kingdom
Birmingham Heartlands Hospital ( Site 1002) Recruiting
Birmingham, United Kingdom, B9 5SS
Contact: Study Coordinator    +441214247456      
Sussex University Hospitals ( Site 1003) Recruiting
Brighton, United Kingdom, BN2 5BE
Contact: Study Coordinator    +44127369695567299      
Western General Hospital ( Site 1009) Recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Study Coordinator    +441315371053      
St James s University Hospital ( Site 1008) Recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Study Coordinator    +4401132433144      
Leicester Royal Infirmary ( Site 1000) Recruiting
Leicester, United Kingdom, LE1 5WW
Contact: Study Coordinator    +441162586295      
University College London Hospitals NHS Foundation Trust ( Site 1006) Recruiting
London, United Kingdom, NW1 2PG
Contact: Study Coordinator    +442034479091      
Chelsea & Westminster Hospital ( Site 1001) Recruiting
London, United Kingdom, SW10 9NH
Contact: Study Coordinator    +442033153383      
Barking Havering and Redbridge University Hospitals NHS Trust Queen s Hospital ( Site 1004) Recruiting
Romford, United Kingdom, RM7 0AG
Contact: Study Coordinator    +4417084350002697      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.

Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03515837     History of Changes
Other Study ID Numbers: 3475-789
MK-3475-789 ( Other Identifier: Merck Protocol Number )
2017-004188-11 ( EudraCT Number )
184019 ( Registry Identifier: JAPIC )
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
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.:
PD1
PD-1
PDL1
PD-L1
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
Carboplatin
Pembrolizumab
Pemetrexed
Pharmaceutical Solutions
Antineoplastic Agents
Antineoplastic Agents, Immunological
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors