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)

NCT03515837 | Completed Phase 3 Results DMC FDA Drug

• 4 other identifiers: 3475-789MK-3475-7891840192017-004188-11
• Study Type: interventional
• Target: 492
• Locations: 17 countries
• Sites: 158

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.

Conditions

Non-small Cell Lung Cancer

Keywords

PD1; PD-1; PDL1; PD-L1

Outcome Measures

Primary Outcomes (2)

• 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 was 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 presented was analyzed using the product-limit (Kaplan-Meier) method for censored data.

  Up to ~40 months

• 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 presented was analyzed using the product-limit (Kaplan-Meier) method for censored data.

  Up to ~51 months

Secondary Outcomes (6)

• Objective Response Rate (ORR) Per RECIST 1.1

  Up to ~51 months

• Duration of Response (DOR) Per RECIST 1.1

  Up to ~51 months

• 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

  Baseline and Week 18

• Time to True Deterioration (TTD) in the EORTC Questionnaire Composite Endpoint of Cough, Chest Pain or Dyspnea

  Baseline and up to ~51 months

• Percentage of Participants Who Experienced an Adverse Event (AE)

  Up to ~44 months

Study Arms (2)

Pembro+Pemetrexed+Chemo

EXPERIMENTAL

Participants receive pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W with no restrictions on the number of cycles PLUS platinum chemotherapy (chemo) (either carboplatin Area Under the Curve \[AUC\] 5 via IV infusion Q3W for 4 cycles \[Cycles 1-4\] or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles \[Cycles 1-4\]).

Biological: pembrolizumab; Drug: pemetrexed; Drug: carboplatin; Drug: cisplatin

Placebo+Pemetrexed+Chemo

ACTIVE COMPARATOR

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

Drug: pemetrexed; Drug: carboplatin; Drug: cisplatin; Drug: saline solution

Interventions

pembrolizumab BIOLOGICAL

IV infusion

Also known as: MK-3475

Pembro+Pemetrexed+Chemo

pemetrexed DRUG

IV infusion

Pembro+Pemetrexed+Chemo; Placebo+Pemetrexed+Chemo

carboplatin DRUG

IV infusion

Pembro+Pemetrexed+Chemo; Placebo+Pemetrexed+Chemo

cisplatin DRUG

IV infusion

Pembro+Pemetrexed+Chemo; Placebo+Pemetrexed+Chemo

saline solution DRUG

IV infusion

Also known as: Normal saline solution

Placebo+Pemetrexed+Chemo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (158)

Cedars-Sinai Medical Center ( Site 0070)

Los Angeles, California, 90048, United States

Location

Pacific Cancer Care ( Site 0058)

Monterey, California, 93940, United States

Location

UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0092)

Orange, California, 92868, United States

Location

St. Joseph Heritage Healthcare ( Site 0003)

Santa Rosa, California, 95403, United States

Location

North Shore University Health System ( Site 0030)

Evanston, Illinois, 60201, United States

Location

Siouxland Regioinal Cancer Center dba June E. Nylen Cancer Center ( Site 0065)

Sioux City, Iowa, 51101, United States

Location

Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 0048)

Edina, Minnesota, 55435, United States

Location

Saint Lukes Hospital of Kansas City ( Site 0060)

Kansas City, Missouri, 64111, United States

Location

New York Oncology Hematology P.C ( Site 8000)

Albany, New York, 12208, United States

Location

Monter Cancer Center ( Site 0054)

Lake Success, New York, 11042, United States

Location

Memorial Sloan Kettering Cancer Center-Rockerfeller Patient Pavilion ( Site 0049)

New York, New York, 10022, United States

Location

White Plains Hospital Center for Cancer Care ( Site 0014)

White Plains, New York, 10601, United States

Location

Providence Portland Medical Center ( Site 0097)

Portland, Oregon, 97213, United States

Location

Kaiser Permanente Northwest ( Site 0037)

Portland, Oregon, 97227, United States

Location

Parkland Health & Hospital System ( Site 2102)

Dallas, Texas, 75235, United States

Location

University of Texas Southwestern Medical Center at Dallas ( Site 0035)

Dallas, Texas, 75390, United States

Location

Utah Cancer Specialists ( Site 0001)

Salt Lake City, Utah, 84106, United States

Location

Emily Couric Clinical Cancer Center ( Site 0020)

Charlottesville, Virginia, 22903, United States

Location

Froedtert Hospital & the Medical College of Wisconsin ( Site 0041)

Milwaukee, Wisconsin, 53226, United States

Location

Chris OBrien Lifehouse ( Site 0200)

Camperdown, New South Wales, 2050, Australia

Location

Westmead Hospital ( Site 0201)

Westmead, New South Wales, 2145, Australia

Location

Eastern Health ( Site 0202)

Box Hill, Victoria, 3128, Australia

Location

Austin Health ( Site 0203)

Heidelberg, Victoria, 3084, Australia

Location

Liga Norte Riograndense Contra o Cancer ( Site 1909)

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

Hospital de Caridade de Ijui ( Site 1907)

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Hospital Bruno Born ( Site 1913)

Lajeado, Rio Grande do Sul, 95900-010, Brazil

Location

Hospital de Clinicas de Porto Alegre ( Site 1905)

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1904)

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1911)

Barretos, São Paulo, 14784-400, Brazil

Location

Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1912)

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 1903)

São Paulo, 01246-000, Brazil

Location

William Osler Health System ( Site 0100)

Brampton, Ontario, L6R 3J7, Canada

Location

Sunnybrook Health Sciences, Odette Cancer Centre ( Site 0102)

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre ( Site 0104)

Toronto, Ontario, M5G 2M9, Canada

Location

Jewish General Hospital ( Site 0105)

Montreal, Quebec, H3T 1E2, Canada

Location

The First Affiliated Hospital of Anhui Medical University ( Site 0721)

Hefei, Anhui, 230088, China

Location

Cancer Hospital Chinese Academy of Medical Sciences ( Site 0717)

Beijing, Beijing Municipality, 100021, China

Location

Peking Union Medical College Hospital ( Site 0703)

Beijing, Beijing Municipality, 100032, China

Location

Beijing Cancer Hospital ( Site 0718)

Beijing, Beijing Municipality, 100036, China

Location

Southwest Hospital, The Third Military Medical University ( Site 0725)

Chongqing, Chongqing Municipality, 400038, China

Location

Fujian Cancer Hospital ( Site 0723)

Fuzhou, Fujian, 350014, China

Location

The Affiliated Tumour Hospital of Harbin Medical University ( Site 0706)

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital ( Site 0711)

Zhengzhou, Henan, 450008, China

Location

Xiangya Hospital of Central South University ( Site 0710)

Changsha, Hunan, 410008, China

Location

Hunan Cancer Hospital ( Site 0722)

Changsha, Hunan, 410013, China

Location

Jiangsu Cancer Hospital ( Site 0719)

Nanjing, Jiangsu, 210000, China

Location

The First Hospital of Jilin University ( Site 0702)

Changchun, Jilin, 130021, China

Location

Jilin Cancer Hospital ( Site 0705)

Changchun, Jilin, 130103, China

Location

Shanghai Chest Hospital ( Site 0700)

Shanghai, Shanghai Municipality, 200030, China

Location

Zhongshan Hospital Fudan University ( Site 0712)

Shanghai, Shanghai Municipality, 200433, China

Location

Tangdu Hospital ( Site 0708)

Xi’an, Shanxi, 710038, China

Location

The First Affiliated Hospital of Xi an Jiaotong University ( Site 0709)

Xi’an, Shanxi, 710061, China

Location

Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0701)

Ürümqi, Xinjiang, 830000, China

Location

The First Affiliated Hospital.Zhejiang University ( Site 0713)

Hangzhou, Zhejiang, 310003, China

Location

Sir Run Run Shaw Hospital School of Medicine, Zhejiang University ( Site 0715)

Hangzhou, Zhejiang, 310016, China

Location

Zhejiang Cancer Hospital ( Site 0716)

Hangzhou, Zhejiang, 310022, China

Location

Centre Leon Berard ( Site 0801)

Lyon, Auvergne, 69008, France

Location

CHU Caen Service de Pneumologie ( Site 0804)

Caen, Calvados, 14033, France

Location

Centre Georges Francois Leclerc ( Site 0809)

Dijon, Cote-d'Or, 21000, France

Location

Hopital Jean Minjoz Besancon ( Site 0805)

Besançon, Doubs, 25030, France

Location

Hopital Prive d'Antony ( Site 0811)

Antony, Hauts-de-Seine, 92160, France

Location

C.H.U. de Tours - Hopital Bretonneau ( Site 0806)

Tours, Indre-et-Loire, 37044, France

Location

Centre D Oncologie de Gentilly ( Site 0810)

Nancy, Meurthe-et-Moselle, 54100, France

Location

Clinique Victor Hugo ( Site 0802)

Le Mans, Sarthe, 72000, France

Location

CHU Poitiers ( Site 0803)

Poitiers, Vienne, 86021, France

Location

Robert Bosch Krankenhaus Klinik Schillerhoehe ( Site 0904)

Gerlingen, Baden-Wurttemberg, 70839, Germany

Location

Universitaetsklinikum Mannheim ( Site 0911)

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Klinikum Wuerzburg Mitte gGmbH ( Site 0901)

Würzburg, Bavaria, 97074, Germany

Location

Pius Hospital Oldenburg ( Site 0905)

Oldenburg, Lower Saxony, 26121, Germany

Location

Florence Nightingale Krankenhaus ( Site 0912)

Düsseldorf, North Rhine-Westphalia, 40489, Germany

Location

Kliniken Essen-Mitte ( Site 0900)

Essen, North Rhine-Westphalia, 45136, Germany

Location

Universitaetsklinikum Muenster ( Site 0906)

Münster, North Rhine-Westphalia, 48149, Germany

Location

Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0907)

Dresden, Saxony, 01307, Germany

Location

Asklepios Klinikum Hamburg ( Site 0908)

Hamburg, 21075, Germany

Location

Hong Kong Integrated Oncology Centre ( Site 0304)

Hong Kong, Hong Kong

Location

Queen Mary Hospital ( Site 0301)

Hong Kong, Hong Kong

Location

Queen Mary Hospital ( Site 0303)

Hong Kong, Hong Kong

Location

Hong Kong United Oncology Centre ( Site 0306)

Kowloon, Hong Kong

Location

Tuen Mun Hospital ( Site 0305)

Tuenmen, Hong Kong

Location

Meir Medical Center ( Site 1701)

Kfar Saba, Central District, 4428164, Israel

Location

Rabin Medical Center ( Site 1704)

Petah Tikva, Central District, 4941492, Israel

Location

Rambam Medical Center ( Site 1703)

Haifa, Heifa, 3109601, Israel

Location

Ha Emek Medical Center ( Site 1707)

Afula, Northern District, 1834111, Israel

Location

Barzilai Medical Center ( Site 1706)

Ashkelon, Southern District, 7830604, Israel

Location

Soroka Medical Center ( Site 1702)

Beersheba, Southern District, 8457108, Israel

Location

Chaim Sheba Medical Center. ( Site 1700)

Ramat Gan, Tell Abib, 5265601, Israel

Location

Sourasky Medical Center ( Site 1705)

Tel Aviv, Tell Abib, 6423906, Israel

Location

Istituto Europeo di Oncologia ( Site 1303)

Milan, Lombardy, 20141, Italy

Location

Ospedale San Vincenzo di Taormina ( Site 1302)

Taormina, Messina, 98039, Italy

Location

AOU San Luigi Gonzaga di Orbassano ( Site 1300)

Orbassano, Torino, 10043, Italy

Location

IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1305)

Bari, 70124, Italy

Location

Azienda Ospedaliero Universitaria Careggi ( Site 1301)

Florence, 50134, Italy

Location

Azienda Ospedaliera dei Colli V. Monaldi ( Site 1306)

Napoli, 80131, Italy

Location

Universita Campus Bio-Medico di Roma ( Site 1304)

Roma, 00128, Italy

Location

National Hospital Organization Nagoya Medical Center ( Site 0608)

Nagoya, Aichi-ken, 460-0001, Japan

Location

Aichi Cancer Center Hospital ( Site 0612)

Nagoya, Aichi-ken, 464-8681, Japan

Location

Fujita Health University Hospital ( Site 0619)

Toyoake, Aichi-ken, 470-1192, Japan

Location

National Cancer Center Hospital East ( Site 0601)

Kashiwa, Chiba, 277-8577, Japan

Location

National Hospital Organization Shikoku Cancer Center ( Site 0616)

Matsuyama, Ehime, 791-0280, Japan

Location

Hyogo Cancer Center ( Site 0604)

Akashi, Hyōgo, 673-8558, Japan

Location

Kanazawa University Hospital ( Site 0617)

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Kanagawa Cancer Center ( Site 0609)

Yokohama, Kanagawa, 241-8515, Japan

Location

Kansai Medical University Hospital ( Site 0606)

Hirakata, Osaka, 573-1191, Japan

Location

Shizuoka Cancer Center Hospital and Research Institute ( Site 0602)

Sunto-gun, Shizuoka, 411-8777, Japan

Location

National Hospital Organization Kyushu Medical Center ( Site 0621)

Fukuoka, 810-8563, Japan

Location

Kyushu University Hospital ( Site 0605)

Fukuoka, 812-8582, Japan

Location

Niigata Cancer Center Hospital ( Site 0610)

Niigata, 951-8566, Japan

Location

Okayama University Hospital ( Site 0614)

Okayama, 700-8558, Japan

Location

Osaka International Cancer Institute ( Site 0611)

Osaka, 541-8567, Japan

Location

National Cancer Center Hospital ( Site 0603)

Tokyo, 104-0045, Japan

Location

Toranomon Hospital ( Site 0615)

Tokyo, 105-8470, Japan

Location

Tokyo Metropolitan Komagome Hospital ( Site 0618)

Tokyo, 113-8677, Japan

Location

Wakayama Medical University Hospital ( Site 0613)

Wakayama, 641-8510, Japan

Location

Instituto Jaliscience de Cancerologia ( Site 2000)

Guadalajara, Jalisco, 44280, Mexico

Location

Medica Sur S.A.B de C.V. ( Site 2003)

Mexico City, 14050, Mexico

Location

Oaxaca Site Management Organization SC ( Site 2001)

Oaxaca City, 68000, Mexico

Location

Instituto Nacional de Cancerologia. ( Site 2007)

Tlalpan, 14080, Mexico

Location

Chungbuk National University Hospital ( Site 0404)

Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644, South Korea

Location

Gachon University Gil Medical Center ( Site 0408)

Incheon, Incheon-gwangyeoksi [Incheon], 21565, South Korea

Location

National Cancer Center ( Site 0400)

Gyeonggi-do, Kyonggi-do, 10408, South Korea

Location

Seoul National University Bundang Hospital ( Site 0405)

Seongnam-si, Kyonggi-do, 13620, South Korea

Location

Seoul National University Hospital ( Site 0402)

Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

Location

Asan Medical Center ( Site 0407)

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

Location

Samsung Medical Center ( Site 0403)

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

Location

The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0406)

Seoul, Seoul-teukbyeolsi [Seoul], 06591, South Korea

Location

Ulsan University Hospital ( Site 0401)

Ulsan, Ulsan-Kwangyokshi, 44033, South Korea

Location

Hospitalo Univ. Germans Trias i Pujol ( Site 1100)

Badalona, Barcelona [Barcelona], 08916, Spain

Location

Hospital de la Santa Creu i Sant Pau ( Site 1102)

Barcelona, Barcelona [Barcelona], 08025, Spain

Location

Hospital Universitari Vall d Hebron ( Site 1106)

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Hospital Ramon y Cajal ( Site 1101)

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre ( Site 1103)

Madrid, 28041, Spain

Location

Complejo Hospitalario Carlos Haya de Malaga ( Site 1107)

Málaga, 29010, Spain

Location

Hospital Universitario Virgen Macarena ( Site 1104)

Seville, 41009, Spain

Location

Linkopings Universitetssjukhus ( Site 1504)

Linköping, Ostergotlands Lan [se-05], 581 85, Sweden

Location

Skanes Universitetssjukhus Lund ( Site 1503)

Lund, Skane Lan [se-12], 221 85, Sweden

Location

Karolinska Universitetssjukhuset Solna ( Site 1500)

Solna, Stockholms Lan [se-01], 171 64, Sweden

Location

Sahlgrenska Universitetssjukhuset ( Site 1502)

Gothenburg, Vastra Gotalands Lan [se-14], 413 45, Sweden

Location

Hualien Tzu Chi Medical Center-Hospital ( Site 0510)

Hualien City, Hualien, 970, Taiwan

Location

Taipei Tzu Chi Hospital ( Site 0512)

New Taipei City, New Taipei, 231, Taiwan

Location

Changhua Christian Hospital ( Site 0509)

Changhua, 50006, Taiwan

Location

National Taiwan University Hospital Hsin-Chu Branch ( Site 0511)

Hsinchu, 300, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital ( Site 0507)

Kaohsiung City, 833, Taiwan

Location

Taipei Medical University Shuang Ho Hospital ( Site 0508)

New Taipei City, 235, Taiwan

Location

China Medical University Hospital ( Site 0505)

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital ( Site 0504)

Taichung, 40705, Taiwan

Location

National Cheng Kung University Hospital ( Site 0506)

Tainan, 704, Taiwan

Location

National Taiwan University Hospital ( Site 0500)

Taipei, 100, Taiwan

Location

Mackay Memorial Hospital ( Site 0503)

Taipei, 104, Taiwan

Location

Taipei Veterans General Hospital ( Site 0501)

Taipei, 11217, Taiwan

Location

Chang Gung Medical Foundation. Linkou ( Site 0502)

Taoyuan District, 333, Taiwan

Location

Sussex University Hospitals ( Site 1003)

Brighton, Brighton And Hove, BN2 5BE, United Kingdom

Location

Western General Hospital ( Site 1009)

Edinburgh, Edinburgh, City of, EH4 2XU, United Kingdom

Location

Leicester Royal Infirmary ( Site 1000)

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

University College London Hospitals NHS Foundation Trust ( Site 1006)

London, London, City of, NW1 2PG, United Kingdom

Location

Chelsea & Westminster Hospital ( Site 1001)

London, London, City of, SW10 9NH, United Kingdom

Location

Birmingham Heartlands Hospital ( Site 1002)

Birmingham, B9 5SS, United Kingdom

Location

St James s University Hospital ( Site 1008)

Leeds, LS9 7TF, United Kingdom

Location

Barking Havering and Redbridge University Hospitals NHS Trust Queen s Hospital ( Site 1004)

Romford, RM7 0AG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39173098 RESULT

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; Pemetrexed; Carboplatin; Cisplatin; Saline Solution

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp and Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 4, 2018
• Study Start: June 29, 2018
• Primary Completion: January 17, 2023
• Study Completion: October 2, 2023
• Last Updated: November 22, 2024
• Results First Posted: January 17, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

IT (7); US (19); SE (4); DE (9); IL (8); BR (8); GB (8); KR (9); FR (9); ES (7); AU (4); CA (4); JP (19); CN (21); ME (4); HK (5); TW (13)