A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604)

NCT ID: NCT03066778

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 453 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-02
• Study Completion Date: 2021-09-21

Brief Summary

The purpose of this study is to assess the safety and efficacy of pembrolizumab plus standard of care (SOC) chemotherapy (etoposide/platinum [EP]) in participants with newly diagnosed extensive stage small cell lung cancer (ES-SCLC) who have not previously received systemic therapy for this malignancy.

The primary study hypotheses are that pembrolizumab+EP prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) and Overall Survival (OS) compared with placebo+EP in adult participants with ES-SCLC. In this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

With protocol Amendment 07 (03-Oct-2018), the outcome measure of "Change from Baseline at Weeks 12 and 24 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale" was replaced with a single time point analysis at Week 18.

Conditions

Small Cell Lung Cancer (SCLC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pembrolizumab+EP

During each 21-day cycle, participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1). Participants who stop pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stop after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, are eligible for up to an additional 1 year of treatment after progressive disease if they meet the criteria for retreatment.

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: BIOLOGICAL

IV infusion on Day 1 of each cycle prior to chemotherapy

Carboplatin

Intervention Type: DRUG

IV infusion on Day 1 of each cycle

Cisplatin

Intervention Type: DRUG

IV infusion on Day 1 of each cycle

Etoposide

Intervention Type: DRUG

IV infusion on Days 1, 2 and 3 of each cycle

Placebo+EP

During each 21-day cycle, participants receive placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1).

Group Type: ACTIVE_COMPARATOR

Normal saline solution

Intervention Type: DRUG

IV infusion on Day 1 of each cycle prior to chemotherapy

Carboplatin

Intervention Type: DRUG

IV infusion on Day 1 of each cycle

Cisplatin

Intervention Type: DRUG

IV infusion on Day 1 of each cycle

Etoposide

Intervention Type: DRUG

IV infusion on Days 1, 2 and 3 of each cycle

Interventions

Pembrolizumab

IV infusion on Day 1 of each cycle prior to chemotherapy

Intervention Type: BIOLOGICAL

Normal saline solution

IV infusion on Day 1 of each cycle prior to chemotherapy

Intervention Type: DRUG

Carboplatin

IV infusion on Day 1 of each cycle

Intervention Type: DRUG

Cisplatin

IV infusion on Day 1 of each cycle

Intervention Type: DRUG

Etoposide

IV infusion on Days 1, 2 and 3 of each cycle

Intervention Type: DRUG

Other Intervention Names

MK-3475; KEYTRUDA®; PARAPLATIN®; PLATINOL®; TOPOSAR™

Eligibility Criteria

Inclusion Criteria

• Has a documented new diagnosis of SCLC by histology or cytology from brushing, washing, or needle aspiration of a defined lesion. Participants who do not have histology samples (defined as core or excisional biopsy, or resections) will need to undergo a new biopsy to provide a tissue sample.
• Has extensive-stage disease defined as Stage IV (T any, N any, M 1a/b) by the American Joint Committee on Cancer (AJCC), Seventh Edition
• Has ≥1 lesion that meets the criteria for measurable, as defined by RECIST 1.1, and is appropriate for selection as a target lesion, as determined by local site investigator/radiology assessment
• Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
• Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Has a life expectancy of ≥3 months
• Has adequate organ function
• Female and male participants of childbearing potential must be willing to use an adequate method of contraception, starting with the first dose of study treatment through 120 days after the last dose of study treatment and up to 180 days after last dose of chemotherapeutic agents

Exclusion Criteria

• Has received prior systemic therapy for the treatment of SCLC
• Is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment for another health-related problem
• Is expected to require any other form of antineoplastic therapy for SCLC, including radiation therapy, while on study. (Prophylactic cranial irradiation will be possible for those participants with stable disease or better at the completion of the 4 cycles of chemotherapy with or without pembrolizumab.)
• Has known central nervous system (ie, brain and/or spinal cord) metastases and/or carcinomatous meningitis. Participants with brain metastases may participate only if they satisfy all of the following:
• Has completed treatment (eg, whole brain radiation treatment [WBRT], stereotactic radiosurgery, or equivalent) ≥14 days prior to the first dose of study treatment,
• Has no evidence of new or enlarging brain metastases confirmed by post-treatment repeat brain imaging performed ≥3 weeks after pre-treatment brain imaging, and
• Is neurologically stable without the need for steroids for ≥7 days before first dose of study treatment.
• Has had major surgery within 3 weeks prior to receiving the first dose of study treatment or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study treatment.
• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
• Has a known history of interstitial lung disease
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
• Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment.
• Has a known history of, or active, neurologic paraneoplastic syndrome
• Has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, and/or abdominal carcinomatosis
• Has a history of a severe hypersensitivity reaction to treatment with another monoclonal antibody
• Is taking chronic systemic steroids (in doses exceeding 10 mg daily of prednisone equivalent) within 7 days prior to the first dose of study treatment
• Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
• Has received a live vaccine within 30 days prior to the first dose of study treatment
• Has 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-programmed cell death-ligand 2 (anti-PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], tumor necrosis factor receptor superfamily member 9 [TNFRSF9, OX-40, CD137]) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial
• Has severe hypersensitivity (Grade ≥3) to pembrolizumab and/or any of its excipients
• Has an active infection requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV) infection
• Has a known history of Hepatitis B or known active Hepatitis C virus infection
• Has a known history of active TB (Bacillus Tuberculosis)
• Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
• Is pregnant or 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 study treatment through and up to 180 days after last dose of chemotherapeutic agents

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Baptist Health Medical Group Oncology, LLC ( Site 8000)

Miami, Florida, United States

Rush University Medical Center ( Site 1215)

Chicago, Illinois, United States

North Shore University Health System ( Site 1216)

Evanston, Illinois, United States

Community Hospital ( Site 1207)

Munster, Indiana, United States

Weinberg Cancer Institute at Franklin Square ( Site 1210)

Baltimore, Maryland, United States

Massachusetts General Hospital ( Site 1203)

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center ( Site 1206)

Boston, Massachusetts, United States

Dana-Farber Cancer Institute [Boston] ( Site 1201)

Boston, Massachusetts, United States

University of Michigan ( Site 1217)

Ann Arbor, Michigan, United States

Henry Ford Health System ( Site 1221)

Detroit, Michigan, United States

Minnesota Oncology Hematology, PA ( Site 8001)

Minneapolis, Minnesota, United States

Hattiesburg Clinic ( Site 1205)

Hattiesburg, Mississippi, United States

Mercy Hospital Saint Louis ( Site 1213)

St Louis, Missouri, United States

Comprehensive Cancer Centers of Nevada ( Site 8004)

Henderson, Nevada, United States

Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1226)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center- Monmouth ( Site 1225)

Middletown, New Jersey, United States

Memorial Sloan-Kettering Cancer Center at Commack ( Site 1227)

Commack, New York, United States

Memorial Sloan Kettering Cancer Center ( Site 1229)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center ( Site 1211)

New York, New York, United States

Memorial Sloan Kettering Cancer Center - Rockville Centre ( Site 1228)

Rockville Centre, New York, United States

Montefiore Einstein Center for Cancer Care - Main site ( Site 1204)

The Bronx, New York, United States

Montefiore Medical Center ( Site 1222)

The Bronx, New York, United States

Duke University Medical Center ( Site 1214)

Durham, North Carolina, United States

Bon Secours St. Francis Health Sytem ( Site 1212)

Greenville, South Carolina, United States

Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 1230)

Nashville, Tennessee, United States

Texas Oncology ( Site 8002)

Austin, Texas, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8003)

Dallas, Texas, United States

Blacktown Hospital ( Site 0004)

Blacktown, New South Wales, Australia

Southern Medical Day Care Centre ( Site 0001)

Wollongong, New South Wales, Australia

St John of God ( Site 0006)

Murdoch, Western Australia, Australia

Lyell McEwin Hospital ( Site 0002)

Elizabeth Vale, , Australia

St Vincents Hospital Melbourne ( Site 0005)

Fitzroy, , Australia

Cancer Care Manitoba ( Site 0159)

Winnipeg, Manitoba, Canada

Nova Scotia Health Authority ( Site 0157)

Halifax, Nova Scotia, Canada

William Osler Health System (Brampton Civic Hospital) ( Site 0161)

Brampton, Ontario, Canada

Kingston Health Sciences Centre ( Site 0155)

Kingston, Ontario, Canada

Sunnybrook Research Institute ( Site 0151)

Toronto, Ontario, Canada

CISSS de la Monteregie-Centre ( Site 0152)

Greenfield Park, Quebec, Canada

CISSS-CA Hotel Dieu de Levis ( Site 0154)

Lévis, Quebec, Canada

CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0158)

Montreal, Quebec, Canada

St. Jerome Medical Research Inc. ( Site 0160)

Saint-Jérôme, Quebec, Canada

Instituto Nacional del Cancer ( Site 0207)

Santiago, Santiago Metropolitan, Chile

Health and Care Chile ( Site 0202)

Santiago, , Chile

Fundacion Arturo Lopez Perez FALP ( Site 0203)

Santiago, , Chile

Pontificia Universidad Catolica de Chile ( Site 0206)

Santiago, , Chile

Clinica Universidad Catolica del Maule ( Site 0208)

Talca, , Chile

CHRU de Lille - Hopital Albert Calmette ( Site 0353)

Lille, , France

C.H.R.U. De Limoges ( Site 0358)

Limoges, , France

CHU Nantes - Hopital Laennec ( Site 0363)

Nantes, , France

Centre Antoine Lacassagne ( Site 0362)

Nice, , France

Hopital Tenon ( Site 0360)

Paris, , France

Institut de Cancerologie Jean-Godinot ( Site 0351)

Reims, , France

CHU de Toulouse - Hopital Larrey ( Site 0354)

Toulouse, , France

Evangelische Lungenklinik Berlin ( Site 0403)

Berlin, , Germany

Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0411)

Dresden, , Germany

Florence Nightingale Krankenhaus ( Site 0413)

Düsseldorf, , Germany

SRH Waldklinikum Gera GmbH ( Site 0405)

Gera, , Germany

Asklepios Klinikum Harburg ( Site 0412)

Hamburg, , Germany

Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0401)

Heidelberg, , Germany

Philipps-Universitat Marburg ( Site 0414)

Marburg, , Germany

Universitaetsklinikum Tuebingen ( Site 0404)

Tübingen, , Germany

Orszagos Onkologiai Intezet ( Site 0453)

Budapest, Pest County, Hungary

Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0452)

Budapest, , Hungary

Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0458)

Budapest, , Hungary

Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0459)

Budapest, , Hungary

Veszprem Megyei Tudogyogyintezet ( Site 0454)

Farkasgyepű, , Hungary

Petz Aladar Megyei Oktato Korhaz ( Site 0460)

Győr, , Hungary

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0456)

Székesfehérvár, , Hungary

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0451)

Szolnok, , Hungary

Zala Megyei Szent Rafael Korhaz ( Site 0457)

Zalaegerszeg, , Hungary

St Vincents University Hospital ( Site 1456)

Dublin, , Ireland

St James Hospital ( Site 1452)

Dublin, , Ireland

Soroka Medical Center ( Site 0505)

Beersheba, , Israel

Ramban Medical Center - Dept. Hemato. & B. Marrow Transplant ( Site 0502)

Haifa, , Israel

Meir Medical Center ( Site 0503)

Kfar Saba, , Israel

Rabin Medical Center ( Site 0504)

Petah Tikva, , Israel

Chaim Sheba Medical Center. ( Site 0501)

Ramat Gan, , Israel

National Hospital Organization Nagoya Medical Center ( Site 0615)

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East ( Site 0613)

Kashiwa, Chiba, Japan

National Hospital Organization Shikoku Cancer Center ( Site 0614)

Matsuyama, Ehime, Japan

Kurume University Hospital ( Site 0609)

Kurume, Fukuoka, Japan

Hyogo Cancer Center ( Site 0611)

Akashi, Hyōgo, Japan

Kanagawa Cancer Center ( Site 0618)

Yokohama, Kanagawa, Japan

Sendai Kousei Hospital ( Site 0602)

Sendai, Miyagi, Japan

National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0608)

Sakai, Osaka, Japan

Shizuoka Cancer Center Hospital and Research Institute ( Site 0607)

Sunto-gun, Shizuoka, Japan

National Hospital Organization Yamaguchi Ube Medical Center ( Site 0601)

Ube, Yamaguchi, Japan

National Hospital Organization Kyushu Medical Center ( Site 0617)

Fukuoka, , Japan

Hiroshima University Hospital ( Site 0604)

Hiroshima, , Japan

Niigata Cancer Center Hospital ( Site 0610)

Niigata, , Japan

Osaka International Cancer Institute ( Site 0616)

Osaka, , Japan

The Cancer Institute Hospital of JFCR ( Site 0606)

Tokyo, , Japan

Wakayama Medical University Hospital ( Site 0612)

Wakayama, , Japan

Canterbury Regional Cancer & Blood Services ( Site 0701)

Christchurch, , New Zealand

Mazowiecki Szpital Onkologiczny ( Site 0757)

Wieliszew, Masovian Voivodeship, Poland

Przychodnia Lekarska Komed ( Site 0769)

Konin, , Poland

Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 0768)

Krakow, , Poland

Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 0767)

Lublin, , Poland

SKPP UM im. Karola Marcinkowkiego w Poznaniu ( Site 0766)

Poznan, , Poland

Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0762)

Poznan, , Poland

Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 0756)

Torun, , Poland

Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 0751)

Warsaw, , Poland

Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 0771)

Wroclaw, , Poland

Belgorod Regional Oncology Dispensary ( Site 0804)

Belgorod, , Russia

N.N. Blokhin NMRCO ( Site 0801)

Moscow, , Russia

SBI of Stavropol region Pyatigorskiy Oncologic dispensary ( Site 0811)

Pyatigorsk, , Russia

SBHI Leningrad Regional Clinical Hospital ( Site 0803)

Saint Petersburg, , Russia

Municipal Clinical Oncology Center ( Site 0802)

Saint Petersburg, , Russia

Inje University Haeundae Paik Hospital ( Site 0905)

Busan, , South Korea

National Cancer Center ( Site 0904)

Goyang-si, , South Korea

Severance Hospital Yonsei University Health System ( Site 0903)

Seoul, , South Korea

Asan Medical Center ( Site 0901)

Seoul, , South Korea

Samsung Medical Center ( Site 0902)

Seoul, , South Korea

Hospital Universitario Insular de Gran Canaria ( Site 0952)

Las Palmas de Gran Canaria, Gran Canaria, Spain

Complejo Hospitalario Universitario de A Coruna ( Site 0953)

A Coruña, , Spain

Hospital del Mar ( Site 0956)

Barcelona, , Spain

Hospital Universitari Vall d Hebron ( Site 0951)

Barcelona, , Spain

Hospital Ciudad de Jaen ( Site 0957)

Jaén, , Spain

Hospital General Universitario Gregorio Maranon ( Site 0958)

Madrid, , Spain

Hospital Universitario Fundacion Jimenez Diaz ( Site 0954)

Madrid, , Spain

Hospital Clinico Universitario de Valencia ( Site 0955)

Valencia, , Spain

Kantonsspital Graubuenden ( Site 1403)

Chur, , Switzerland

CHUV Centre Hospitalier Universitaire Vaudois ( Site 1405)

Lausanne, , Switzerland

Universitaetsspital Zuerich ( Site 1404)

Zurich, , Switzerland

Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F. ( Site 1005)

Kaohsiung City, , Taiwan

China Medical University Hospital. ( Site 1003)

Taichung, , Taiwan

Taichung Veterans General Hospital ( Site 1007)

Taichung, , Taiwan

National Cheng Kung University Hospital ( Site 1004)

Tainan City, , Taiwan

Chi Mei Medical Center Liuying ( Site 1006)

Tainan City, , Taiwan

National Taiwan University Hospital ( Site 1001)

Taipei, , Taiwan

Taipei Veterans General Hospital ( Site 1002)

Taipei, , Taiwan

Ege Universitesi Tıp Fakultesi ( Site 1052)

Izmir, Bornova, Turkey (Türkiye)

Baskent University Adana Dr. Turgut Noyan EAH ( Site 1057)

Adana, , Turkey (Türkiye)

Ankara UTF ( Site 1055)

Ankara, , Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1060)

Ankara, , Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH ( Site 1053)

Ankara, , Turkey (Türkiye)

Trakya Uni. Tip Fakultesi ( Site 1063)

Edirne, , Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1058)

Istanbul, , Turkey (Türkiye)

Medipol Hastanesi ( Site 1066)

Istanbul, , Turkey (Türkiye)

Medeniyet Uni. Goztepe Egitim ve Arast. Hast. ( Site 1064)

Istanbul, , Turkey (Türkiye)

Medical Park Izmir Hospital ( Site 1051)

Izmir, , Turkey (Türkiye)

Kocaeli Universitesi Tip Fakultesi ( Site 1061)

Kocaeli, , Turkey (Türkiye)

Inonu Universitesi Tip Fakultesi ( Site 1059)

Malatya, , Turkey (Türkiye)

Birmingham Heartlands Hospital ( Site 1162)

Birmingham, , United Kingdom

St James s University Hospital ( Site 1161)

Leeds, , United Kingdom

North Middlesex Hospital ( Site 1151)

London, , United Kingdom

Maidstone Hospital ( Site 1155)

Maidstone, , United Kingdom

Mount Vernon Cancer Centre ( Site 1156)

Northwood, , United Kingdom

Countries

United States; Australia; Canada; Chile; France; Germany; Hungary; Ireland; Israel; Japan; New Zealand; Poland; Russia; South Korea; Spain; Switzerland; Taiwan; Turkey (Türkiye); United Kingdom

References

Rudin CM, Awad MM, Navarro A, Gottfried M, Peters S, Csoszi T, Cheema PK, Rodriguez-Abreu D, Wollner M, Yang JC, Mazieres J, Orlandi FJ, Luft A, Gumus M, Kato T, Kalemkerian GP, Luo Y, Ebiana V, Pietanza MC, Kim HR; KEYNOTE-604 Investigators. Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study. J Clin Oncol. 2020 Jul 20;38(21):2369-2379. doi: 10.1200/JCO.20.00793. Epub 2020 May 29.

Reference Type: RESULT

PMID: 32468956 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://merckoncologyclinicaltrials.com

Merck Oncology Clinical Trials Information

Other Identifiers

173744

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-3475-604

Identifier Type: OTHER

Identifier Source: secondary_id

KEYNOTE-604

Identifier Type: OTHER

Identifier Source: secondary_id

2016-004309-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3475-604

Identifier Type: -

Identifier Source: org_study_id