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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)

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pembrolizumab
pemetrexed
carboplatin
cisplatin
saline solution
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring PD1, PD-1, PDL1, PD-L1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cedars-Sinai Medical Center ( Site 0070)
  • Pacific Cancer Care ( Site 0058)
  • UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0092)
  • St. Joseph Heritage Healthcare ( Site 0003)
  • North Shore University Health System ( Site 0030)
  • Siouxland Regioinal Cancer Center dba June E. Nylen Cancer Center ( Site 0065)
  • Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 0048)
  • Saint Lukes Hospital of Kansas City ( Site 0060)
  • New York Oncology Hematology P.C ( Site 8000)
  • Monter Cancer Center ( Site 0054)
  • Memorial Sloan Kettering Cancer Center-Rockerfeller Patient Pavilion ( Site 0049)
  • White Plains Hospital Center for Cancer Care ( Site 0014)
  • Providence Portland Medical Center ( Site 0097)
  • Kaiser Permanente Northwest ( Site 0037)
  • Parkland Health & Hospital System ( Site 2102)
  • University of Texas Southwestern Medical Center at Dallas ( Site 0035)
  • Utah Cancer Specialists ( Site 0001)
  • Emily Couric Clinical Cancer Center ( Site 0020)
  • Froedtert Hospital & the Medical College of Wisconsin ( Site 0041)
  • Chris OBrien Lifehouse ( Site 0200)
  • Westmead Hospital ( Site 0201)
  • Eastern Health ( Site 0202)
  • Austin Health ( Site 0203)
  • Liga Norte Riograndense Contra o Cancer ( Site 1909)
  • Hospital de Caridade de Ijui ( Site 1907)
  • Hospital Bruno Born ( Site 1913)
  • Hospital de Clinicas de Porto Alegre ( Site 1905)
  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1904)
  • Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1911)
  • Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1912)
  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 1903)
  • William Osler Health System ( Site 0100)
  • Sunnybrook Health Sciences, Odette Cancer Centre ( Site 0102)
  • Princess Margaret Cancer Centre ( Site 0104)
  • Jewish General Hospital ( Site 0105)
  • The First Affiliated Hospital of Anhui Medical University ( Site 0721)
  • Cancer Hospital Chinese Academy of Medical Sciences ( Site 0717)
  • Peking Union Medical College Hospital ( Site 0703)
  • Beijing Cancer Hospital ( Site 0718)
  • Southwest Hospital, The Third Military Medical University ( Site 0725)
  • Fujian Cancer Hospital ( Site 0723)
  • The Affiliated Tumour Hospital of Harbin Medical University ( Site 0706)
  • Henan Cancer Hospital ( Site 0711)
  • Xiangya Hospital of Central South University ( Site 0710)
  • Hunan Cancer Hospital ( Site 0722)
  • Jiangsu Cancer Hospital ( Site 0719)
  • The First Hospital of Jilin University ( Site 0702)
  • Jilin Cancer Hospital ( Site 0705)
  • Shanghai Chest Hospital ( Site 0700)
  • Zhongshan Hospital Fudan University ( Site 0712)
  • Tangdu Hospital ( Site 0708)
  • The First Affiliated Hospital of Xi an Jiaotong University ( Site 0709)
  • Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0701)
  • The First Affiliated Hospital.Zhejiang University ( Site 0713)
  • Sir Run Run Shaw Hospital School of Medicine, Zhejiang University ( Site 0715)
  • Zhejiang Cancer Hospital ( Site 0716)
  • Centre Leon Berard ( Site 0801)
  • CHU Caen Service de Pneumologie ( Site 0804)
  • Centre Georges Francois Leclerc ( Site 0809)
  • Hopital Jean Minjoz Besancon ( Site 0805)
  • Hopital Prive d'Antony ( Site 0811)
  • C.H.U. de Tours - Hopital Bretonneau ( Site 0806)
  • Centre D Oncologie de Gentilly ( Site 0810)
  • Clinique Victor Hugo ( Site 0802)
  • CHU Poitiers ( Site 0803)
  • Robert Bosch Krankenhaus Klinik Schillerhoehe ( Site 0904)
  • Universitaetsklinikum Mannheim ( Site 0911)
  • Klinikum Wuerzburg Mitte gGmbH ( Site 0901)
  • Pius Hospital Oldenburg ( Site 0905)
  • Florence Nightingale Krankenhaus ( Site 0912)
  • Kliniken Essen-Mitte ( Site 0900)
  • Universitaetsklinikum Muenster ( Site 0906)
  • Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0907)
  • Asklepios Klinikum Hamburg ( Site 0908)
  • Hong Kong Integrated Oncology Centre ( Site 0304)
  • Queen Mary Hospital ( Site 0301)
  • Queen Mary Hospital ( Site 0303)
  • Hong Kong United Oncology Centre ( Site 0306)
  • Tuen Mun Hospital ( Site 0305)
  • Barzilai Medical Center ( Site 1706)
  • Soroka Medical Center ( Site 1702)
  • Meir Medical Center ( Site 1701)
  • Rabin Medical Center ( Site 1704)
  • Ha Emek Medical Center ( Site 1707)
  • Rambam Medical Center ( Site 1703)
  • Chaim Sheba Medical Center. ( Site 1700)
  • Sourasky Medical Center ( Site 1705)
  • Istituto Europeo di Oncologia ( Site 1303)
  • Ospedale San Vincenzo di Taormina ( Site 1302)
  • AOU San Luigi Gonzaga di Orbassano ( Site 1300)
  • IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1305)
  • Azienda Ospedaliero Universitaria Careggi ( Site 1301)
  • Azienda Ospedaliera dei Colli V. Monaldi ( Site 1306)
  • Universita Campus Bio-Medico di Roma ( Site 1304)
  • National Hospital Organization Nagoya Medical Center ( Site 0608)
  • Aichi Cancer Center Hospital ( Site 0612)
  • Fujita Health University Hospital ( Site 0619)
  • National Cancer Center Hospital East ( Site 0601)
  • National Hospital Organization Shikoku Cancer Center ( Site 0616)
  • Hyogo Cancer Center ( Site 0604)
  • Kanazawa University Hospital ( Site 0617)
  • Kanagawa Cancer Center ( Site 0609)
  • Kansai Medical University Hospital ( Site 0606)
  • Shizuoka Cancer Center Hospital and Research Institute ( Site 0602)
  • National Hospital Organization Kyushu Medical Center ( Site 0621)
  • Kyushu University Hospital ( Site 0605)
  • Niigata Cancer Center Hospital ( Site 0610)
  • Okayama University Hospital ( Site 0614)
  • Osaka International Cancer Institute ( Site 0611)
  • National Cancer Center Hospital ( Site 0603)
  • Toranomon Hospital ( Site 0615)
  • Tokyo Metropolitan Komagome Hospital ( Site 0618)
  • Wakayama Medical University Hospital ( Site 0613)
  • Chungbuk National University Hospital ( Site 0404)
  • Gachon University Gil Medical Center ( Site 0408)
  • National Cancer Center ( Site 0400)
  • Seoul National University Bundang Hospital ( Site 0405)
  • Seoul National University Hospital ( Site 0402)
  • Asan Medical Center ( Site 0407)
  • Samsung Medical Center ( Site 0403)
  • The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0406)
  • Ulsan University Hospital ( Site 0401)
  • Instituto Jaliscience de Cancerologia ( Site 2000)
  • Medica Sur S.A.B de C.V. ( Site 2003)
  • Oaxaca Site Management Organization SC ( Site 2001)
  • Instituto Nacional de Cancerologia. ( Site 2007)
  • Hospitalo Univ. Germans Trias i Pujol ( Site 1100)
  • Hospital de la Santa Creu i Sant Pau ( Site 1102)
  • Hospital Universitari Vall d Hebron ( Site 1106)
  • Hospital Ramon y Cajal ( Site 1101)
  • Hospital Universitario 12 de Octubre ( Site 1103)
  • Complejo Hospitalario Carlos Haya de Malaga ( Site 1107)
  • Hospital Universitario Virgen Macarena ( Site 1104)
  • Linkopings Universitetssjukhus ( Site 1504)
  • Skanes Universitetssjukhus Lund ( Site 1503)
  • Karolinska Universitetssjukhuset Solna ( Site 1500)
  • Sahlgrenska Universitetssjukhuset ( Site 1502)
  • Taipei Tzu Chi Hospital ( Site 0512)
  • Changhua Christian Hospital ( Site 0509)
  • National Taiwan University Hospital Hsin-Chu Branch ( Site 0511)
  • Hualien Tzu Chi Medical Center-Hospital ( Site 0510)
  • Kaohsiung Chang Gung Memorial Hospital ( Site 0507)
  • Taipei Medical University Shuang Ho Hospital ( Site 0508)
  • China Medical University Hospital ( Site 0505)
  • Taichung Veterans General Hospital ( Site 0504)
  • National Cheng Kung University Hospital ( Site 0506)
  • National Taiwan University Hospital ( Site 0500)
  • Mackay Memorial Hospital ( Site 0503)
  • Taipei Veterans General Hospital ( Site 0501)
  • Chang Gung Medical Foundation. Linkou ( Site 0502)
  • Sussex University Hospitals ( Site 1003)
  • Western General Hospital ( Site 1009)
  • Leicester Royal Infirmary ( Site 1000)
  • University College London Hospitals NHS Foundation Trust ( Site 1006)
  • Chelsea & Westminster Hospital ( Site 1001)
  • Birmingham Heartlands Hospital ( Site 1002)
  • St James s University Hospital ( Site 1008)
  • Barking Havering and Redbridge University Hospitals NHS Trust Queen s Hospital ( Site 1004)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pembro+Pemetrexed+Chemo

Placebo+Pemetrexed+Chemo

Arm Description

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]).

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]).

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
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.
Overall Survival (OS)
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

Objective Response Rate (ORR) Per RECIST 1.1
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.
Duration of Response (DOR) Per RECIST 1.1
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.
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
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.
Time to True Deterioration (TTD) in the EORTC Questionnaire Composite Endpoint of Cough, Chest Pain or Dyspnea
TTD is the time from baseline to first onset of 10 points or more deterioration 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.
Adverse Events (AEs)
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.
Study Treatment Discontinuations Due to AEs
The number of participants who discontinue study treatment due to an AE will be presented.
Change from Baseline in EORTC-QLQ-C30 Quality of Life (Item 30) Scale Score
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.

Full Information

First Posted
April 23, 2018
Last Updated
October 10, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03515837
Brief Title
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)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 29, 2018 (Actual)
Primary Completion Date
January 17, 2023 (Actual)
Study Completion Date
October 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
PD1, PD-1, PDL1, PD-L1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
492 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pembro+Pemetrexed+Chemo
Arm Type
Experimental
Arm Description
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]).
Arm Title
Placebo+Pemetrexed+Chemo
Arm Type
Active Comparator
Arm Description
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]).
Intervention Type
Biological
Intervention Name(s)
pembrolizumab
Other Intervention Name(s)
MK-3475
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
saline solution
Other Intervention Name(s)
Normal saline solution
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Description
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.
Time Frame
Up to approximately 40 months
Title
Overall Survival (OS)
Description
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.
Time Frame
Up to approximately 66 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) Per RECIST 1.1
Description
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.
Time Frame
Up to approximately 32 months
Title
Duration of Response (DOR) Per RECIST 1.1
Description
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.
Time Frame
Up to approximately 32 months
Title
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
Description
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.
Time Frame
Baseline and Week 12, Week 27
Title
Time to True Deterioration (TTD) in the EORTC Questionnaire Composite Endpoint of Cough, Chest Pain or Dyspnea
Description
TTD is the time from baseline to first onset of 10 points or more deterioration 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.
Time Frame
Up to approximately 32 months
Title
Adverse Events (AEs)
Description
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.
Time Frame
Up to 90 days after last dose of study treatment (Up to approximately 42 months)
Title
Study Treatment Discontinuations Due to AEs
Description
The number of participants who discontinue study treatment due to an AE will be presented.
Time Frame
Up to approximately 39 months
Title
Change from Baseline in EORTC-QLQ-C30 Quality of Life (Item 30) Scale Score
Description
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.
Time Frame
Baseline and Week 12, Week 27

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Cedars-Sinai Medical Center ( Site 0070)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pacific Cancer Care ( Site 0058)
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0092)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
St. Joseph Heritage Healthcare ( Site 0003)
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
North Shore University Health System ( Site 0030)
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Siouxland Regioinal Cancer Center dba June E. Nylen Cancer Center ( Site 0065)
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 0048)
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Saint Lukes Hospital of Kansas City ( Site 0060)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
New York Oncology Hematology P.C ( Site 8000)
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Monter Cancer Center ( Site 0054)
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center-Rockerfeller Patient Pavilion ( Site 0049)
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
White Plains Hospital Center for Cancer Care ( Site 0014)
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Facility Name
Providence Portland Medical Center ( Site 0097)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Kaiser Permanente Northwest ( Site 0037)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Parkland Health & Hospital System ( Site 2102)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas ( Site 0035)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Utah Cancer Specialists ( Site 0001)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Emily Couric Clinical Cancer Center ( Site 0020)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Froedtert Hospital & the Medical College of Wisconsin ( Site 0041)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Chris OBrien Lifehouse ( Site 0200)
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Westmead Hospital ( Site 0201)
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Eastern Health ( Site 0202)
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Austin Health ( Site 0203)
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Liga Norte Riograndense Contra o Cancer ( Site 1909)
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
Hospital de Caridade de Ijui ( Site 1907)
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Hospital Bruno Born ( Site 1913)
City
Lajeado
State/Province
Rio Grande Do Sul
ZIP/Postal Code
95900-010
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre ( Site 1905)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1904)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1911)
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1912)
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 1903)
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
William Osler Health System ( Site 0100)
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Sunnybrook Health Sciences, Odette Cancer Centre ( Site 0102)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Cancer Centre ( Site 0104)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Jewish General Hospital ( Site 0105)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
The First Affiliated Hospital of Anhui Medical University ( Site 0721)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230088
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences ( Site 0717)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Peking Union Medical College Hospital ( Site 0703)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Beijing Cancer Hospital ( Site 0718)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100036
Country
China
Facility Name
Southwest Hospital, The Third Military Medical University ( Site 0725)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Fujian Cancer Hospital ( Site 0723)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
The Affiliated Tumour Hospital of Harbin Medical University ( Site 0706)
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital ( Site 0711)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Xiangya Hospital of Central South University ( Site 0710)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Hunan Cancer Hospital ( Site 0722)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Jiangsu Cancer Hospital ( Site 0719)
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
The First Hospital of Jilin University ( Site 0702)
City
Chang chun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Jilin Cancer Hospital ( Site 0705)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130103
Country
China
Facility Name
Shanghai Chest Hospital ( Site 0700)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Zhongshan Hospital Fudan University ( Site 0712)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Tangdu Hospital ( Site 0708)
City
XI An
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
Facility Name
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0709)
City
XI An
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0701)
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Facility Name
The First Affiliated Hospital.Zhejiang University ( Site 0713)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Sir Run Run Shaw Hospital School of Medicine, Zhejiang University ( Site 0715)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Zhejiang Cancer Hospital ( Site 0716)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Centre Leon Berard ( Site 0801)
City
Lyon
State/Province
Auvergne
ZIP/Postal Code
69008
Country
France
Facility Name
CHU Caen Service de Pneumologie ( Site 0804)
City
Caen
State/Province
Calvados
ZIP/Postal Code
14033
Country
France
Facility Name
Centre Georges Francois Leclerc ( Site 0809)
City
Dijon
State/Province
Cote-d'Or
ZIP/Postal Code
21000
Country
France
Facility Name
Hopital Jean Minjoz Besancon ( Site 0805)
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25030
Country
France
Facility Name
Hopital Prive d'Antony ( Site 0811)
City
Antony
State/Province
Hauts-de-Seine
ZIP/Postal Code
92160
Country
France
Facility Name
C.H.U. de Tours - Hopital Bretonneau ( Site 0806)
City
Tours
State/Province
Indre-et-Loire
ZIP/Postal Code
37044
Country
France
Facility Name
Centre D Oncologie de Gentilly ( Site 0810)
City
Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54100
Country
France
Facility Name
Clinique Victor Hugo ( Site 0802)
City
Le Mans
State/Province
Sarthe
ZIP/Postal Code
72000
Country
France
Facility Name
CHU Poitiers ( Site 0803)
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Facility Name
Robert Bosch Krankenhaus Klinik Schillerhoehe ( Site 0904)
City
Gerlingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
70839
Country
Germany
Facility Name
Universitaetsklinikum Mannheim ( Site 0911)
City
Mannheim
State/Province
Baden-Wurttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Klinikum Wuerzburg Mitte gGmbH ( Site 0901)
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97074
Country
Germany
Facility Name
Pius Hospital Oldenburg ( Site 0905)
City
Oldenburg
State/Province
Niedersachsen
ZIP/Postal Code
26121
Country
Germany
Facility Name
Florence Nightingale Krankenhaus ( Site 0912)
City
Duesseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40489
Country
Germany
Facility Name
Kliniken Essen-Mitte ( Site 0900)
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Universitaetsklinikum Muenster ( Site 0906)
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0907)
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Asklepios Klinikum Hamburg ( Site 0908)
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Hong Kong Integrated Oncology Centre ( Site 0304)
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital ( Site 0301)
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital ( Site 0303)
City
Hong Kong
Country
Hong Kong
Facility Name
Hong Kong United Oncology Centre ( Site 0306)
City
Kowloon
Country
Hong Kong
Facility Name
Tuen Mun Hospital ( Site 0305)
City
Tuen Mun
Country
Hong Kong
Facility Name
Barzilai Medical Center ( Site 1706)
City
Ashkelon
State/Province
HaDarom
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Soroka Medical Center ( Site 1702)
City
Beer-Sheva
State/Province
HaDarom
ZIP/Postal Code
8457108
Country
Israel
Facility Name
Meir Medical Center ( Site 1701)
City
Kfar-Saba
State/Province
HaMerkaz
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center ( Site 1704)
City
Petah Tikva
State/Province
HaMerkaz
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Ha Emek Medical Center ( Site 1707)
City
Afula
State/Province
HaTsafon
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Rambam Medical Center ( Site 1703)
City
Haifa
State/Province
Heifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Chaim Sheba Medical Center. ( Site 1700)
City
Ramat Gan
State/Province
Tell Abib
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Sourasky Medical Center ( Site 1705)
City
Tel Aviv
State/Province
Tell Abib
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Istituto Europeo di Oncologia ( Site 1303)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Ospedale San Vincenzo di Taormina ( Site 1302)
City
Taormina
State/Province
Messina
ZIP/Postal Code
98039
Country
Italy
Facility Name
AOU San Luigi Gonzaga di Orbassano ( Site 1300)
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1305)
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi ( Site 1301)
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Azienda Ospedaliera dei Colli V. Monaldi ( Site 1306)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Universita Campus Bio-Medico di Roma ( Site 1304)
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
National Hospital Organization Nagoya Medical Center ( Site 0608)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Aichi Cancer Center Hospital ( Site 0612)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Fujita Health University Hospital ( Site 0619)
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
National Cancer Center Hospital East ( Site 0601)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center ( Site 0616)
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Hyogo Cancer Center ( Site 0604)
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Kanazawa University Hospital ( Site 0617)
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kanagawa Cancer Center ( Site 0609)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Kansai Medical University Hospital ( Site 0606)
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Shizuoka Cancer Center Hospital and Research Institute ( Site 0602)
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center ( Site 0621)
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Kyushu University Hospital ( Site 0605)
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Niigata Cancer Center Hospital ( Site 0610)
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Okayama University Hospital ( Site 0614)
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka International Cancer Institute ( Site 0611)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
National Cancer Center Hospital ( Site 0603)
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Toranomon Hospital ( Site 0615)
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Tokyo Metropolitan Komagome Hospital ( Site 0618)
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
Wakayama Medical University Hospital ( Site 0613)
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Chungbuk National University Hospital ( Site 0404)
City
Cheongju si
State/Province
Chungcheongbuk-do [Chungbuk]
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center ( Site 0408)
City
Incheon
State/Province
Incheon-gwangyeoksi [Incheon]
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
National Cancer Center ( Site 0400)
City
Gyeonggi-do
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital ( Site 0405)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital ( Site 0402)
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 0407)
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 0403)
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0406)
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Ulsan University Hospital ( Site 0401)
City
Ulsan
State/Province
Ulsan-Kwangyokshi
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Instituto Jaliscience de Cancerologia ( Site 2000)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Medica Sur S.A.B de C.V. ( Site 2003)
City
Mexico City
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Oaxaca Site Management Organization SC ( Site 2001)
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Instituto Nacional de Cancerologia. ( Site 2007)
City
Tlalpan
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Hospitalo Univ. Germans Trias i Pujol ( Site 1100)
City
Badalona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau ( Site 1102)
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitari Vall d Hebron ( Site 1106)
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Ramon y Cajal ( Site 1101)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre ( Site 1103)
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Complejo Hospitalario Carlos Haya de Malaga ( Site 1107)
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena ( Site 1104)
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Linkopings Universitetssjukhus ( Site 1504)
City
Linkoping
State/Province
Ostergotlands Lan [se-05]
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Skanes Universitetssjukhus Lund ( Site 1503)
City
Lund
State/Province
Skane Lan [se-12]
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Solna ( Site 1500)
City
Solna
State/Province
Stockholms Lan [se-01]
ZIP/Postal Code
171 64
Country
Sweden
Facility Name
Sahlgrenska Universitetssjukhuset ( Site 1502)
City
Goteborg
State/Province
Vastra Gotalands Lan [se-14]
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Taipei Tzu Chi Hospital ( Site 0512)
City
New Taipei City
State/Province
New Taipei
ZIP/Postal Code
231
Country
Taiwan
Facility Name
Changhua Christian Hospital ( Site 0509)
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
National Taiwan University Hospital Hsin-Chu Branch ( Site 0511)
City
Hsinchu
ZIP/Postal Code
300
Country
Taiwan
Facility Name
Hualien Tzu Chi Medical Center-Hospital ( Site 0510)
City
Hualien
ZIP/Postal Code
970
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital ( Site 0507)
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Taipei Medical University Shuang Ho Hospital ( Site 0508)
City
New Taipei
ZIP/Postal Code
235
Country
Taiwan
Facility Name
China Medical University Hospital ( Site 0505)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital ( Site 0504)
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital ( Site 0506)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 0500)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Mackay Memorial Hospital ( Site 0503)
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Taipei Veterans General Hospital ( Site 0501)
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Medical Foundation. Linkou ( Site 0502)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Sussex University Hospitals ( Site 1003)
City
Brighton
State/Province
Brighton And Hove
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Western General Hospital ( Site 1009)
City
Edinburgh
State/Province
Edinburgh, City Of
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Leicester Royal Infirmary ( Site 1000)
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust ( Site 1006)
City
London
State/Province
London, City Of
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Chelsea & Westminster Hospital ( Site 1001)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital ( Site 1002)
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
St James s University Hospital ( Site 1008)
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Barking Havering and Redbridge University Hospitals NHS Trust Queen s Hospital ( Site 1004)
City
Romford
ZIP/Postal Code
RM7 0AG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

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)

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