Lung Cancer Clinical 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)

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.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

492

Study ID:

NCT03515837

Recruitment Status:

Completed

Sponsor:

Merck Sharp & Dohme LLC

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There are 151 Locations for this study

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Cedars-Sinai Medical Center ( Site 0070)
Los Angeles California, 90048, United States
Pacific Cancer Care ( Site 0058)
Monterey California, 93940, United States
UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0092)
Orange California, 92868, United States
St. Joseph Heritage Healthcare ( Site 0003)
Santa Rosa California, 95403, United States
North Shore University Health System ( Site 0030)
Evanston Illinois, 60201, United States
Siouxland Regioinal Cancer Center dba June E. Nylen Cancer Center ( Site 0065)
Sioux City Iowa, 51101, United States
Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 0048)
Edina Minnesota, 55435, United States
Saint Lukes Hospital of Kansas City ( Site 0060)
Kansas City Missouri, 64111, United States
New York Oncology Hematology P.C ( Site 8000)
Albany New York, 12208, United States
Monter Cancer Center ( Site 0054)
Lake Success New York, 11042, United States
Memorial Sloan Kettering Cancer Center-Rockerfeller Patient Pavilion ( Site 0049)
New York New York, 10022, United States
White Plains Hospital Center for Cancer Care ( Site 0014)
White Plains New York, 10601, United States
Providence Portland Medical Center ( Site 0097)
Portland Oregon, 97213, United States
Kaiser Permanente Northwest ( Site 0037)
Portland Oregon, 97227, United States
Parkland Health & Hospital System ( Site 2102)
Dallas Texas, 75235, United States
University of Texas Southwestern Medical Center at Dallas ( Site 0035)
Dallas Texas, 75390, United States
Utah Cancer Specialists ( Site 0001)
Salt Lake City Utah, 84106, United States
Emily Couric Clinical Cancer Center ( Site 0020)
Charlottesville Virginia, 22903, United States
Froedtert Hospital & the Medical College of Wisconsin ( Site 0041)
Milwaukee Wisconsin, 53226, United States
Chris OBrien Lifehouse ( Site 0200)
Camperdown New South Wales, 2050, Australia
Westmead Hospital ( Site 0201)
Westmead New South Wales, 2145, Australia
Eastern Health ( Site 0202)
Box Hill Victoria, 3128, Australia
Austin Health ( Site 0203)
Heidelberg Victoria, 3084, Australia
Liga Norte Riograndense Contra o Cancer ( Site 1909)
Natal Rio Grande Do Norte, 59075, Brazil
Hospital de Caridade de Ijui ( Site 1907)
Ijui Rio Grande Do Sul, 98700, Brazil
Hospital Bruno Born ( Site 1913)
Lajeado Rio Grande Do Sul, 95900, Brazil
Hospital de Clinicas de Porto Alegre ( Site 1905)
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1904)
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1911)
Barretos Sao Paulo, 14784, Brazil
Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1912)
Ribeirao Preto Sao Paulo, 14048, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 1903)
Sao Paulo , 01246, Brazil
William Osler Health System ( Site 0100)
Brampton Ontario, L6R 3, Canada
Sunnybrook Health Sciences, Odette Cancer Centre ( Site 0102)
Toronto Ontario, M4N 3, Canada
Princess Margaret Cancer Centre ( Site 0104)
Toronto Ontario, M5G 2, Canada
Jewish General Hospital ( Site 0105)
Montreal Quebec, H3T 1, Canada
The First Affiliated Hospital of Anhui Medical University ( Site 0721)
Hefei Anhui, 23008, China
Cancer Hospital Chinese Academy of Medical Sciences ( Site 0717)
Beijing Beijing, 10002, China
Peking Union Medical College Hospital ( Site 0703)
Beijing Beijing, 10003, China
Beijing Cancer Hospital ( Site 0718)
Beijing Beijing, 10003, China
Southwest Hospital, The Third Military Medical University ( Site 0725)
Chongqing Chongqing, 40003, China
Fujian Cancer Hospital ( Site 0723)
Fuzhou Fujian, 35001, China
The Affiliated Tumour Hospital of Harbin Medical University ( Site 0706)
Harbin Heilongjiang, 15008, China
Henan Cancer Hospital ( Site 0711)
Zhengzhou Henan, 45000, China
Xiangya Hospital of Central South University ( Site 0710)
Changsha Hunan, 41000, China
Hunan Cancer Hospital ( Site 0722)
Changsha Hunan, 41001, China
Jiangsu Cancer Hospital ( Site 0719)
Nanjing Jiangsu, 21000, China
The First Hospital of Jilin University ( Site 0702)
Chang chun Jilin, 13002, China
Jilin Cancer Hospital ( Site 0705)
Changchun Jilin, 13010, China
Shanghai Chest Hospital ( Site 0700)
Shanghai Shanghai, 20003, China
Zhongshan Hospital Fudan University ( Site 0712)
Shanghai Shanghai, 20043, China
Tangdu Hospital ( Site 0708)
XI An Shanxi, 71003, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0709)
XI An Shanxi, 71006, China
Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0701)
Urumqi Xinjiang, 83000, China
The First Affiliated Hospital.Zhejiang University ( Site 0713)
Hangzhou Zhejiang, 31000, China
Sir Run Run Shaw Hospital School of Medicine, Zhejiang University ( Site 0715)
Hangzhou Zhejiang, 31001, China
Zhejiang Cancer Hospital ( Site 0716)
Hangzhou Zhejiang, 31002, China
Centre Leon Berard ( Site 0801)
Lyon Auvergne, 69008, France
CHU Caen Service de Pneumologie ( Site 0804)
Caen Calvados, 14033, France
Centre Georges Francois Leclerc ( Site 0809)
Dijon Cote-d'Or, 21000, France
Hopital Jean Minjoz Besancon ( Site 0805)
Besancon Doubs, 25030, France
Hopital Prive d'Antony ( Site 0811)
Antony Hauts-de-Seine, 92160, France
C.H.U. de Tours - Hopital Bretonneau ( Site 0806)
Tours Indre-et-Loire, 37044, France
Centre D Oncologie de Gentilly ( Site 0810)
Nancy Meurthe-et-Moselle, 54100, France
Clinique Victor Hugo ( Site 0802)
Le Mans Sarthe, 72000, France
CHU Poitiers ( Site 0803)
Poitiers Vienne, 86021, France
Robert Bosch Krankenhaus Klinik Schillerhoehe ( Site 0904)
Gerlingen Baden-Wurttemberg, 70839, Germany
Universitaetsklinikum Mannheim ( Site 0911)
Mannheim Baden-Wurttemberg, 68167, Germany
Klinikum Wuerzburg Mitte gGmbH ( Site 0901)
Wuerzburg Bayern, 97074, Germany
Pius Hospital Oldenburg ( Site 0905)
Oldenburg Niedersachsen, 26121, Germany
Florence Nightingale Krankenhaus ( Site 0912)
Duesseldorf Nordrhein-Westfalen, 40489, Germany
Kliniken Essen-Mitte ( Site 0900)
Essen Nordrhein-Westfalen, 45136, Germany
Universitaetsklinikum Muenster ( Site 0906)
Muenster Nordrhein-Westfalen, 48149, Germany
Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0907)
Dresden Sachsen, 01307, Germany
Asklepios Klinikum Hamburg ( Site 0908)
Hamburg , 21075, Germany
Hong Kong Integrated Oncology Centre ( Site 0304)
Hong Kong , , Hong Kong
Queen Mary Hospital ( Site 0301)
Hong Kong , , Hong Kong
Queen Mary Hospital ( Site 0303)
Hong Kong , , Hong Kong
Hong Kong United Oncology Centre ( Site 0306)
Kowloon , , Hong Kong
Tuen Mun Hospital ( Site 0305)
Tuen Mun , , Hong Kong
Barzilai Medical Center ( Site 1706)
Ashkelon HaDarom, 78306, Israel
Soroka Medical Center ( Site 1702)
Beer-Sheva HaDarom, 84571, Israel
Meir Medical Center ( Site 1701)
Kfar-Saba HaMerkaz, 44281, Israel
Rabin Medical Center ( Site 1704)
Petah Tikva HaMerkaz, 49414, Israel
Ha Emek Medical Center ( Site 1707)
Afula HaTsafon, 18341, Israel
Rambam Medical Center ( Site 1703)
Haifa Heifa, 31096, Israel
Chaim Sheba Medical Center. ( Site 1700)
Ramat Gan Tell Abib, 52656, Israel
Sourasky Medical Center ( Site 1705)
Tel Aviv Tell Abib, 64239, Israel
Istituto Europeo di Oncologia ( Site 1303)
Milano Lombardia, 20141, Italy
Ospedale San Vincenzo di Taormina ( Site 1302)
Taormina Messina, 98039, Italy
AOU San Luigi Gonzaga di Orbassano ( Site 1300)
Orbassano Torino, 10043, Italy
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1305)
Bari , 70124, Italy
Azienda Ospedaliero Universitaria Careggi ( Site 1301)
Firenze , 50134, Italy
Azienda Ospedaliera dei Colli V. Monaldi ( Site 1306)
Napoli , 80131, Italy
Universita Campus Bio-Medico di Roma ( Site 1304)
Roma , 00128, Italy
National Hospital Organization Nagoya Medical Center ( Site 0608)
Nagoya Aichi, 460-0, Japan
Aichi Cancer Center Hospital ( Site 0612)
Nagoya Aichi, 464-8, Japan
Fujita Health University Hospital ( Site 0619)
Toyoake Aichi, 470-1, Japan
National Cancer Center Hospital East ( Site 0601)
Kashiwa Chiba, 277-8, Japan
National Hospital Organization Shikoku Cancer Center ( Site 0616)
Matsuyama Ehime, 791-0, Japan
Hyogo Cancer Center ( Site 0604)
Akashi Hyogo, 673-8, Japan
Kanazawa University Hospital ( Site 0617)
Kanazawa Ishikawa, 920-8, Japan
Kanagawa Cancer Center ( Site 0609)
Yokohama Kanagawa, 241-8, Japan
Kansai Medical University Hospital ( Site 0606)
Hirakata Osaka, 573-1, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 0602)
Sunto-gun Shizuoka, 411-8, Japan
National Hospital Organization Kyushu Medical Center ( Site 0621)
Fukuoka , 810-8, Japan
Kyushu University Hospital ( Site 0605)
Fukuoka , 812-8, Japan
Niigata Cancer Center Hospital ( Site 0610)
Niigata , 951-8, Japan
Okayama University Hospital ( Site 0614)
Okayama , 700-8, Japan
Osaka International Cancer Institute ( Site 0611)
Osaka , 541-8, Japan
National Cancer Center Hospital ( Site 0603)
Tokyo , 104-0, Japan
Toranomon Hospital ( Site 0615)
Tokyo , 105-8, Japan
Tokyo Metropolitan Komagome Hospital ( Site 0618)
Tokyo , 113-8, Japan
Wakayama Medical University Hospital ( Site 0613)
Wakayama , 641-8, Japan
Chungbuk National University Hospital ( Site 0404)
Cheongju si Chungcheongbuk-do [Chungbuk], 28644, Korea, Republic of
Gachon University Gil Medical Center ( Site 0408)
Incheon Incheon-gwangyeoksi [Incheon], 21565, Korea, Republic of
National Cancer Center ( Site 0400)
Gyeonggi-do Kyonggi-do, 10408, Korea, Republic of
Seoul National University Bundang Hospital ( Site 0405)
Seongnam-si Kyonggi-do, 13620, Korea, Republic of
Seoul National University Hospital ( Site 0402)
Seoul Seoul-teukbyeolsi [Seoul], 03080, Korea, Republic of
Asan Medical Center ( Site 0407)
Seoul Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of
Samsung Medical Center ( Site 0403)
Seoul Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0406)
Seoul Seoul-teukbyeolsi [Seoul], 06591, Korea, Republic of
Ulsan University Hospital ( Site 0401)
Ulsan Ulsan-Kwangyokshi, 44033, Korea, Republic of
Instituto Jaliscience de Cancerologia ( Site 2000)
Guadalajara Jalisco, 44280, Mexico
Medica Sur S.A.B de C.V. ( Site 2003)
Mexico City , 14050, Mexico
Oaxaca Site Management Organization SC ( Site 2001)
Oaxaca , 68000, Mexico
Instituto Nacional de Cancerologia. ( Site 2007)
Tlalpan , 14080, Mexico
Hospitalo Univ. Germans Trias i Pujol ( Site 1100)
Badalona Barcelona [Barcelona], 08916, Spain
Hospital de la Santa Creu i Sant Pau ( Site 1102)
Barcelona Barcelona [Barcelona], 08025, Spain
Hospital Universitari Vall d Hebron ( Site 1106)
Barcelona Barcelona [Barcelona], 08035, Spain
Hospital Ramon y Cajal ( Site 1101)
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre ( Site 1103)
Madrid , 28041, Spain
Complejo Hospitalario Carlos Haya de Malaga ( Site 1107)
Malaga , 29010, Spain
Hospital Universitario Virgen Macarena ( Site 1104)
Sevilla , 41009, Spain
Linkopings Universitetssjukhus ( Site 1504)
Linkoping Ostergotlands Lan [se-05], 581 8, Sweden
Skanes Universitetssjukhus Lund ( Site 1503)
Lund Skane Lan [se-12], 221 8, Sweden
Karolinska Universitetssjukhuset Solna ( Site 1500)
Solna Stockholms Lan [se-01], 171 6, Sweden
Sahlgrenska Universitetssjukhuset ( Site 1502)
Goteborg Vastra Gotalands Lan [se-14], 413 4, Sweden
Taipei Tzu Chi Hospital ( Site 0512)
New Taipei City New Taipei, 231, Taiwan
Changhua Christian Hospital ( Site 0509)
Changhua , 50006, Taiwan
National Taiwan University Hospital Hsin-Chu Branch ( Site 0511)
Hsinchu , 300, Taiwan
Hualien Tzu Chi Medical Center-Hospital ( Site 0510)
Hualien , 970, Taiwan
Kaohsiung Chang Gung Memorial Hospital ( Site 0507)
Kaohsiung , 833, Taiwan
Taipei Medical University Shuang Ho Hospital ( Site 0508)
New Taipei , 235, Taiwan
China Medical University Hospital ( Site 0505)
Taichung , 40447, Taiwan
Taichung Veterans General Hospital ( Site 0504)
Taichung , 40705, Taiwan
National Cheng Kung University Hospital ( Site 0506)
Tainan , 704, Taiwan
National Taiwan University Hospital ( Site 0500)
Taipei , 100, Taiwan
Mackay Memorial Hospital ( Site 0503)
Taipei , 104, Taiwan
Taipei Veterans General Hospital ( Site 0501)
Taipei , 11217, Taiwan
Chang Gung Medical Foundation. Linkou ( Site 0502)
Taoyuan , 333, Taiwan
Sussex University Hospitals ( Site 1003)
Brighton Brighton And Hove, BN2 5, United Kingdom
Western General Hospital ( Site 1009)
Edinburgh Edinburgh, City Of, EH4 2, United Kingdom
Leicester Royal Infirmary ( Site 1000)
Leicester Leicestershire, LE1 5, United Kingdom
University College London Hospitals NHS Foundation Trust ( Site 1006)
London London, City Of, NW1 2, United Kingdom
Chelsea & Westminster Hospital ( Site 1001)
London London, City Of, SW10 , United Kingdom
Birmingham Heartlands Hospital ( Site 1002)
Birmingham , B9 5S, United Kingdom
St James s University Hospital ( Site 1008)
Leeds , LS9 7, United Kingdom
Barking Havering and Redbridge University Hospitals NHS Trust Queen s Hospital ( Site 1004)
Romford , RM7 0, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

492

Study ID:

NCT03515837

Recruitment Status:

Completed

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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