Clinical trial NCT03515837: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: PD1
PD-1
PDL1
PD-L1
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-05-04
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to ~40 months
measure: Overall Survival (OS)
timeFrame: Up to ~51 months
Secondary outcomes:
measure: Objective Response Rate (ORR) Per RECIST 1.1
timeFrame: Up to ~51 months
measure: Duration of Response (DOR) Per RECIST 1.1
timeFrame: Up to ~51 months
measure: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
timeFrame: Baseline and Week 18
measure: Time to True Deterioration (TTD) in the EORTC Questionnaire Composite Endpoint of Cough, Chest Pain or Dyspnea
timeFrame: Baseline and up to ~51 months
measure: Percentage of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to ~44 months
measure: Percentage of Participants Who Discontinued Study Treatment Due to AEs
timeFrame: Up to ~41 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center ( Site 0070)
state: California
city: Monterey
country: United States
facility: Pacific Cancer Care ( Site 0058)
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0092)
state: California
city: Santa Rosa
country: United States
facility: St. Joseph Heritage Healthcare ( Site 0003)
state: California
city: Evanston
country: United States
facility: North Shore University Health System ( Site 0030)
state: Illinois
city: Sioux City
country: United States
facility: Siouxland Regioinal Cancer Center dba June E. Nylen Cancer Center ( Site 0065)
state: Iowa
city: Edina
country: United States
facility: Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 0048)
state: Minnesota
city: Kansas City
country: United States
facility: Saint Lukes Hospital of Kansas City ( Site 0060)
state: Missouri
city: Albany
country: United States
facility: New York Oncology Hematology P.C ( Site 8000)
state: New York
city: Lake Success
country: United States
facility: Monter Cancer Center ( Site 0054)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center-Rockerfeller Patient Pavilion ( Site 0049)
state: New York
city: White Plains
country: United States
facility: White Plains Hospital Center for Cancer Care ( Site 0014)
state: New York
city: Portland
country: United States
facility: Providence Portland Medical Center ( Site 0097)
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente Northwest ( Site 0037)
state: Oregon
city: Dallas
country: United States
facility: Parkland Health & Hospital System ( Site 2102)
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas ( Site 0035)
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists ( Site 0001)
state: Utah
city: Charlottesville
country: United States
facility: Emily Couric Clinical Cancer Center ( Site 0020)
state: Virginia
city: Milwaukee
country: United States
facility: Froedtert Hospital & the Medical College of Wisconsin ( Site 0041)
state: Wisconsin
city: Camperdown
country: Australia
facility: Chris OBrien Lifehouse ( Site 0200)
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 0201)
state: New South Wales
city: Box Hill
country: Australia
facility: Eastern Health ( Site 0202)
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health ( Site 0203)
state: Victoria
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Cancer ( Site 1909)
state: Rio Grande Do Norte
city: Ijui
country: Brazil
facility: Hospital de Caridade de Ijui ( Site 1907)
state: Rio Grande Do Sul
city: Lajeado
country: Brazil
facility: Hospital Bruno Born ( Site 1913)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre ( Site 1905)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1904)
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1911)
state: Sao Paulo
city: Ribeirao Preto
country: Brazil
facility: Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1912)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 1903)
city: Brampton
country: Canada
facility: William Osler Health System ( Site 0100)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences, Odette Cancer Centre ( Site 0102)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0104)
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital ( Site 0105)
state: Quebec
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University ( Site 0721)
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 0717)
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital ( Site 0703)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 0718)
state: Beijing
city: Chongqing
country: China
facility: Southwest Hospital, The Third Military Medical University ( Site 0725)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital ( Site 0723)
state: Fujian
city: Harbin
country: China
facility: The Affiliated Tumour Hospital of Harbin Medical University ( Site 0706)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 0711)
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University ( Site 0710)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 0722)
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital ( Site 0719)
state: Jiangsu
city: Chang chun
country: China
facility: The First Hospital of Jilin University ( Site 0702)
state: Jilin
city: Changchun
country: China
facility: Jilin Cancer Hospital ( Site 0705)
state: Jilin
city: Shanghai
country: China
facility: Shanghai Chest Hospital ( Site 0700)
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University ( Site 0712)
state: Shanghai
city: XI An
country: China
facility: Tangdu Hospital ( Site 0708)
state: Shanxi
city: XI An
country: China
facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0709)
state: Shanxi
city: Urumqi
country: China
facility: Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0701)
state: Xinjiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital.Zhejiang University ( Site 0713)
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital School of Medicine, Zhejiang University ( Site 0715)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 0716)
state: Zhejiang
city: Lyon
country: France
facility: Centre Leon Berard ( Site 0801)
state: Auvergne
city: Caen
country: France
facility: CHU Caen Service de Pneumologie ( Site 0804)
state: Calvados
city: Dijon
country: France
facility: Centre Georges Francois Leclerc ( Site 0809)
state: Cote-d'Or
city: Besancon
country: France
facility: Hopital Jean Minjoz Besancon ( Site 0805)
state: Doubs
city: Antony
country: France
facility: Hopital Prive d'Antony ( Site 0811)
state: Hauts-de-Seine
city: Tours
country: France
facility: C.H.U. de Tours - Hopital Bretonneau ( Site 0806)
state: Indre-et-Loire
city: Nancy
country: France
facility: Centre D Oncologie de Gentilly ( Site 0810)
state: Meurthe-et-Moselle
city: Le Mans
country: France
facility: Clinique Victor Hugo ( Site 0802)
state: Sarthe
city: Poitiers
country: France
facility: CHU Poitiers ( Site 0803)
state: Vienne
city: Gerlingen
country: Germany
facility: Robert Bosch Krankenhaus Klinik Schillerhoehe ( Site 0904)
state: Baden-Wurttemberg
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim ( Site 0911)
state: Baden-Wurttemberg
city: Wuerzburg
country: Germany
facility: Klinikum Wuerzburg Mitte gGmbH ( Site 0901)
state: Bayern
city: Oldenburg
country: Germany
facility: Pius Hospital Oldenburg ( Site 0905)
state: Niedersachsen
city: Duesseldorf
country: Germany
facility: Florence Nightingale Krankenhaus ( Site 0912)
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Kliniken Essen-Mitte ( Site 0900)
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster ( Site 0906)
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0907)
state: Sachsen
city: Hamburg
country: Germany
facility: Asklepios Klinikum Hamburg ( Site 0908)
city: Hong Kong
country: Hong Kong
facility: Hong Kong Integrated Oncology Centre ( Site 0304)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital ( Site 0301)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital ( Site 0303)
city: Kowloon
country: Hong Kong
facility: Hong Kong United Oncology Centre ( Site 0306)
city: Tuen Mun
country: Hong Kong
facility: Tuen Mun Hospital ( Site 0305)
city: Ashkelon
country: Israel
facility: Barzilai Medical Center ( Site 1706)
state: HaDarom
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center ( Site 1702)
state: HaDarom
city: Kfar-Saba
country: Israel
facility: Meir Medical Center ( Site 1701)
state: HaMerkaz
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1704)
state: HaMerkaz
city: Afula
country: Israel
facility: Ha Emek Medical Center ( Site 1707)
state: HaTsafon
city: Haifa
country: Israel
facility: Rambam Medical Center ( Site 1703)
state: Heifa
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center. ( Site 1700)
state: Tell Abib
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 1705)
state: Tell Abib
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia ( Site 1303)
state: Lombardia
city: Taormina
country: Italy
facility: Ospedale San Vincenzo di Taormina ( Site 1302)
state: Messina
city: Orbassano
country: Italy
facility: AOU San Luigi Gonzaga di Orbassano ( Site 1300)
state: Torino
city: Bari
country: Italy
facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1305)
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi ( Site 1301)
city: Napoli
country: Italy
facility: Azienda Ospedaliera dei Colli V. Monaldi ( Site 1306)
city: Roma
country: Italy
facility: Universita Campus Bio-Medico di Roma ( Site 1304)
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center ( Site 0608)
state: Aichi
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 0612)
state: Aichi
city: Toyoake
country: Japan
facility: Fujita Health University Hospital ( Site 0619)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0601)
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 0616)
state: Ehime
city: Akashi
country: Japan
facility: Hyogo Cancer Center ( Site 0604)
state: Hyogo
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 0617)
state: Ishikawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 0609)
state: Kanagawa
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 0606)
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0602)
state: Shizuoka
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center ( Site 0621)
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 0605)
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 0610)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 0614)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 0611)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 0603)
city: Tokyo
country: Japan
facility: Toranomon Hospital ( Site 0615)
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Komagome Hospital ( Site 0618)
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital ( Site 0613)
city: Cheongju si
country: Korea, Republic of
facility: Chungbuk National University Hospital ( Site 0404)
state: Chungcheongbuk-do [Chungbuk]
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center ( Site 0408)
state: Incheon-gwangyeoksi [Incheon]
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center ( Site 0400)
state: Kyonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 0405)
state: Kyonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 0402)
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 0407)
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0403)
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0406)
state: Seoul-teukbyeolsi [Seoul]
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital ( Site 0401)
state: Ulsan-Kwangyokshi
city: Guadalajara
country: Mexico
facility: Instituto Jaliscience de Cancerologia ( Site 2000)
state: Jalisco
city: Mexico City
country: Mexico
facility: Medica Sur S.A.B de C.V. ( Site 2003)
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization SC ( Site 2001)
city: Tlalpan
country: Mexico
facility: Instituto Nacional de Cancerologia. ( Site 2007)
city: Badalona
country: Spain
facility: Hospitalo Univ. Germans Trias i Pujol ( Site 1100)
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau ( Site 1102)
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron ( Site 1106)
state: Barcelona [Barcelona]
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal ( Site 1101)
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre ( Site 1103)
city: Malaga
country: Spain
facility: Complejo Hospitalario Carlos Haya de Malaga ( Site 1107)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena ( Site 1104)
city: Linkoping
country: Sweden
facility: Linkopings Universitetssjukhus ( Site 1504)
state: Ostergotlands Lan [se-05]
city: Lund
country: Sweden
facility: Skanes Universitetssjukhus Lund ( Site 1503)
state: Skane Lan [se-12]
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 1500)
state: Stockholms Lan [se-01]
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset ( Site 1502)
state: Vastra Gotalands Lan [se-14]
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi Hospital ( Site 0512)
state: New Taipei
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital ( Site 0509)
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch ( Site 0511)
city: Hualien
country: Taiwan
facility: Hualien Tzu Chi Medical Center-Hospital ( Site 0510)
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0507)
city: New Taipei
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital ( Site 0508)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 0505)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 0504)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 0506)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0500)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital ( Site 0503)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 0501)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation. Linkou ( Site 0502)
city: Brighton
country: United Kingdom
facility: Sussex University Hospitals ( Site 1003)
state: Brighton And Hove
city: Edinburgh
country: United Kingdom
facility: Western General Hospital ( Site 1009)
state: Edinburgh, City Of
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary ( Site 1000)
state: Leicestershire
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust ( Site 1006)
state: London, City Of
city: London
country: United Kingdom
facility: Chelsea & Westminster Hospital ( Site 1001)
state: London, City Of
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital ( Site 1002)
city: Leeds
country: United Kingdom
facility: St James s University Hospital ( Site 1008)
city: Romford
country: United Kingdom
facility: Barking Havering and Redbridge University Hospitals NHS Trust Queen s Hospital ( Site 1004)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Yang JC, Lee DH, Lee JS, Fan Y, de Marinis F, Iwama E, Inoue T, Rodriguez-Cid J, Zhang L, Yang CT, de la Mora Jimenez E, Zhou J, Perol M, Lee KH, Vicente D, Ichihara E, Riely GJ, Luo Y, Chirovsky D, Pietanza MC, Bhagwati N, Lu S. Phase III KEYNOTE-789 Study of Pemetrexed and Platinum With or Without Pembrolizumab for Tyrosine Kinase Inhibitor-Resistant, EGFR-Mutant, Metastatic Nonsquamous Non-Small Cell Lung Cancer. J Clin Oncol. 2024 Dec;42(34):4029-4039. doi: 10.1200/JCO.23.02747. Epub 2024 Aug 22.