A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)

September 16, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)

The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

680

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Instituto Medico Especializado Alexander Fleming ( Site 2457)
        • Contact:
          • Study Coordinator
          • Phone Number: +541132218900
      • Córdoba, Argentina, X5001HWE
        • Recruiting
        • Instituto Oncologico de Cordoba -IONC ( Site 2455)
        • Contact:
          • Study Coordinator
          • Phone Number: 5493516165267
    • Buenos Aires
      • Caba., Buenos Aires, Argentina, C1431FWO
        • Recruiting
        • CEMIC ( Site 2454)
        • Contact:
          • Study Coordinator
          • Phone Number: 5411529901002543
      • Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina, C1199ABB
        • Recruiting
        • Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2459)
        • Contact:
          • Study Coordinator
          • Phone Number: 49590200
    • Río Negro Province
      • Bariloche, Río Negro Province, Argentina, R8402APU
        • Recruiting
        • Fundacion Intecnus ( Site 2456)
        • Contact:
          • Study Coordinator
          • Phone Number: 0294154293757
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2001SBK
        • Recruiting
        • Centro Médico IPAM ( Site 2452)
        • Contact:
          • Study Coordinator
          • Phone Number: +543414858585
  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
        • Recruiting
        • Calvary Mater Newcastle ( Site 2106)
        • Contact:
          • Study Coordinator
          • Phone Number: 61240143584
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Completed
        • Tasman Oncology Research ( Site 2104)
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital ( Site 2102)
        • Contact:
          • Study Coordinator
          • Phone Number: 0061731763515
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Recruiting
        • Grampians Health ( Site 2101)
        • Contact:
          • Study Coordinator
          • Phone Number: 61(03)53208500
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • One Clinical Research ( Site 2103)
        • Contact:
          • Study Coordinator
          • Phone Number: 0061862799466
  • Belgium
    • Bruxelles-Capitale, Region de
      • Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc ( Site 1203)
        • Contact:
          • Study Coordinator
          • Phone Number: +32.2.764.79.25
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Recruiting
        • Jessa Ziekenhuis ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 11 33 50 23
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 9 332 59 11
  • Brazil
      • Rio de Janeiro, Brazil, 20230-130
        • Recruiting
        • Instituto Nacional de Câncer - INCA ( Site 2501)
        • Contact:
          • Study Coordinator
          • Phone Number: +552132076564
    • Ceará
      • Fortaleza, Ceará, Brazil, 60336-550
        • Recruiting
        • CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 2502)
        • Contact:
          • Study Coordinator
          • Phone Number: +5585991372979
    • Goiás
      • Goiânia, Goiás, Brazil, 74605070
        • Recruiting
        • Hospital Araújo Jorge ( Site 2514)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 062 99339-2208
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59062-000
        • Recruiting
        • Liga Norte Riograndense Contra o Cancer ( Site 2513)
        • Contact:
          • Study Coordinator
          • Phone Number: +558440095595
    • Rio Grande do Sul
      • Bento Gonçalves, Rio Grande do Sul, Brazil, 95700-000
        • Recruiting
        • Hospital Tacchini ( Site 2506)
        • Contact:
          • Study Coordinator
          • Phone Number: 555434554333x1125
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010-260
        • Recruiting
        • Hospital de Clínicas de Passo Fundo ( Site 2504)
        • Contact:
          • Study Coordinator
          • Phone Number: +555421033490
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
        • Recruiting
        • Hospital Moinhos de Vento ( Site 2510)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 51 99604-4976
      • Porto Alegre, Rio Grande do Sul, Brazil, 91359-200
        • Recruiting
        • Hospital Nossa Senhora Da Conceicao ( Site 2512)
        • Contact:
          • Study Coordinator
          • Phone Number: +555133572092
      • Santa Cruz do Sul, Rio Grande do Sul, Brazil, 96830-180
        • Recruiting
        • Instituto de Oncologia Saint Gallen ( Site 2507)
        • Contact:
          • Study Coordinator
          • Phone Number: +555130568686
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Recruiting
        • Hospital de Amor - Barretos ( Site 2511)
        • Contact:
          • Study Coordinator
          • Phone Number: +551733216638
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Recruiting
        • MHAT - Heart and Brain ( Site 1252)
        • Contact:
          • Study Coordinator
          • Phone Number: +35964678400
    • Pazardzhik
      • Panagyurishte, Pazardzhik, Bulgaria, 4500
        • Recruiting
        • MBAL Uni Hospital ( Site 1253)
        • Contact:
          • Study Coordinator
          • Phone Number: +35935788581
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Recruiting
        • Queen Elizabeth II Health Sciences Centre ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: 9024738317
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Hamilton Health Sciences - Juravinski Site ( Site 1104)
        • Contact:
          • Study Coordinator
          • Phone Number: 9053879495
      • Kingston, Ontario, Canada, K7L 2V7
        • Recruiting
        • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1105)
        • Contact:
          • Study Coordinator
          • Phone Number: 6135496666
      • Oshawa, Ontario, Canada, L1G 2B9
        • Recruiting
        • Lakeridge Health ( Site 1107)
        • Contact:
          • Study Coordinator
          • Phone Number: 905-576-8711x32802
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute ( Site 1106)
        • Contact:
          • Study Coordinator
          • Phone Number: 4164806100
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: 5149341934
      • Québec, Quebec, Canada, G1V 4G5
        • Recruiting
        • IUCPQ ( Site 1112)
        • Contact:
          • Study Coordinator
          • Phone Number: 4186568711
  • Chile
      • Antofagasta, Chile, 1263521
        • Recruiting
        • Bradford Hill Norte ( Site 2563)
        • Contact:
          • Study Coordinator
          • Phone Number: +56552655924
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500713
        • Recruiting
        • Orlandi Oncologia ( Site 2555)
        • Contact:
          • Study Coordinator
          • Phone Number: 56226057491
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP ( Site 2551)
        • Contact:
          • Study Coordinator
          • Phone Number: 56224205098
      • Santiago, Region M. de Santiago, Chile, 7650018
        • Recruiting
        • Clínica RedSalud Vitacura ( Site 2556)
        • Contact:
          • Study Coordinator
          • Phone Number: 56223954044
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill ( Site 2552)
        • Contact:
          • Study Coordinator
          • Phone Number: 56229490970
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Recruiting
        • ONCOCENTRO APYS ( Site 2554)
        • Contact:
          • Study Coordinator
          • Phone Number: 56323320850
  • Colombia
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110131
        • Recruiting
        • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 2603)
        • Contact:
          • Study Coordinator
          • Phone Number: +573016348173
      • Bogotá, Bogota D.C., Colombia, 110231
        • Recruiting
        • Hospital Universitario San Ignacio ( Site 2610)
        • Contact:
          • Study Coordinator
          • Phone Number: 573108658288
      • Bogotá, Bogota D.C., Colombia, 111321
        • Recruiting
        • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 2604)
        • Contact:
          • Study Coordinator
          • Phone Number: 573103130894
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • Recruiting
        • IMAT S.A.S ( Site 2602)
        • Contact:
          • Study Coordinator
          • Phone Number: +573135342052
    • Risaralda Department
      • Pereira, Risaralda Department, Colombia, 660001
        • Recruiting
        • Oncologos del Occidente ( Site 2608)
        • Contact:
          • Study Coordinator
          • Phone Number: +573187715522
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Completed
        • Fundacion Valle del Lili- CIC ( Site 2601)
  • Finland
    • Northern Savonia
      • Oulu, Northern Savonia, Finland, 90220
        • Recruiting
        • Oulun yliopistollinen sairaala ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: +35883153789
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20520
        • Recruiting
        • Turku University Hospital ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: +35823138709
  • France
      • Paris, France, 75013
        • Recruiting
        • Pitie Salpetriere University Hospital ( Site 1355)
        • Contact:
          • Study Coordinator
          • Phone Number: 33142160508
    • Basse-Normandie
      • Caen, Basse-Normandie, France, 14033
        • Recruiting
        • Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1359)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 2 31 06 43 88
    • Centre-Val de Loire
      • Tours, Centre-Val de Loire, France, 3700
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 1354)
        • Contact:
          • Study Coordinator
          • Phone Number: 33247478701
    • Franche-Comte
      • Besançon, Franche-Comte, France, 25000
        • Completed
        • CHU Besançon ( Site 1358)
    • Loire-Atlantique
      • Saint-Herblain, Loire-Atlantique, France, 44800
        • Recruiting
        • Institut De Cancerologie De L Ouest ( Site 1357)
        • Contact:
          • Study Coordinator
          • Phone Number: +33240679900
    • Nord
      • Lille, Nord, France, 59037
        • Recruiting
        • Institut Cœur Poumon -CHU Lille ( Site 1352)
        • Contact:
          • Study Coordinator
          • Phone Number: +333.20.44.59.62
    • Rhone
      • Lyon, Rhone, France, 69008
        • Recruiting
        • CENTRE LEON BERARD ( Site 1351)
        • Contact:
          • Study Coordinator
          • Phone Number: +33478782828
    • Île-de-France Region
      • Villejuif, Île-de-France Region, France, 94805
        • Recruiting
        • Gustave Roussy ( Site 1353)
        • Contact:
          • Study Coordinator
          • Phone Number: + 33 1 42 11 67 78
  • Germany
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69126
        • Recruiting
        • Thoraxklinik-Heidelberg gGmbH ( Site 1412)
        • Contact:
          • Study Coordinator
          • Phone Number: +4962213961350
      • Stuttgart, Baden-Wurttemberg, Germany, 70736
        • Recruiting
        • Robert-Bosch-Krankenhaus ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: 0049 711 8101-7757
    • Bavaria
      • Kempten (Allgäu), Bavaria, Germany, 87439
        • Recruiting
        • Klinikverbund Allgäu gGmbH ( Site 1408)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 0831 530 1934
    • Hesse
      • Giessen, Hesse, Germany, 35392
        • Recruiting
        • UKGM Gießen/Marburg ( Site 1404)
        • Contact:
          • Study Coordinator
          • Phone Number: 004964198543591
    • Lower Saxony
      • Oldenburg, Lower Saxony, Germany, 26121
        • Recruiting
        • Pius Hospital Oldenburg ( Site 1407)
        • Contact:
          • Study Coordinator
          • Phone Number: +494412291611
    • North Rhine-Westphalia
      • Eschweiler, North Rhine-Westphalia, Germany, 52249
        • Recruiting
        • St.-Antonius-Hospital ( Site 1411)
        • Contact:
          • Study Coordinator
          • Phone Number: 0049 2403-761737
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Recruiting
        • Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 1405)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 251 83-52712
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Recruiting
        • Marienhaus Klinikum Mainz ( Site 1403)
        • Contact:
          • Study Coordinator
          • Phone Number: 0049 6131/57583 2406
  • Greece
      • Thessaloniki, Greece, 564 29
        • Recruiting
        • Papageorgiou General Hospital of Thessaloniki ( Site 1454)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2313323867
    • Achaia
      • Pátrai, Achaia, Greece, 265 04
        • Recruiting
        • UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1452)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2613603791
    • Attica
      • Athens, Attica, Greece, 115 26
        • Recruiting
        • Errikos Dunant Hospital Center ( Site 1457)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2106972246
      • Athens, Attica, Greece, 115 27
        • Recruiting
        • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1451)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2107700220
      • Athens, Attica, Greece, 185 47
        • Recruiting
        • Metropolitan Hospital ( Site 1459)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2104807106
      • Chaïdári, Attica, Greece, 124 62
        • Recruiting
        • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1460)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2313301848
    • Irakleio
      • Heraklion, Irakleio, Greece, 715 00
        • Recruiting
        • University General Hospital of Herakleion ( Site 1458)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2810392091
    • Thessaly
      • Larissa, Thessaly, Greece, 411 10
        • Recruiting
        • University General Hospital of Larissa-Oncology Clinic ( Site 1453)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2413501636
  • Hungary
      • Budapest, Hungary, 1121
        • Recruiting
        • Orszagos Koranyi Pulmonologiai Intezet ( Site 1501)
        • Contact:
          • Study Coordinator
          • Phone Number: +3613913213
    • Fejér
      • Székesfehérvár, Fejér, Hungary, 8000
        • Recruiting
        • Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 1506)
        • Contact:
          • Study Coordinator
          • Phone Number: (06 22) 535 500
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Hungary, 9024
        • Recruiting
        • Petz Aladár Megyei Oktató Kórház ( Site 1502)
        • Contact:
          • Study Coordinator
          • Phone Number: +36704454354
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Completed
        • Debreceni Egyetem Altalanos Orvostudomanyi Kar Tudogyogyaszati Tanszek ( Site 1508)
    • Heves County
      • Mátraháza, Heves County, Hungary, 3233
        • Recruiting
        • Mátrai Gyógyintézet ( Site 1504)
        • Contact:
          • Study Coordinator
          • Phone Number: +36 37 574 500
    • Nógrád megye
      • Salgótarján, Nógrád megye, Hungary, 3100
        • Recruiting
        • Nograd Varmegyei Szent Lazar Korhaz ( Site 1509)
        • Contact:
          • Study Coordinator
          • Phone Number: +3632522000
    • Pest County
      • Törökbálint, Pest County, Hungary, 2045
        • Recruiting
        • Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: +36307005601
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Recruiting
        • Somogy Vármegyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1507)
        • Contact:
          • Study Coordinator
          • Phone Number: +3682501300/1669
  • Ireland
      • Cork, Ireland, T12 E8YV
        • Recruiting
        • Cork University Hospital ( Site 1553)
        • Contact:
          • Study Coordinator
          • Phone Number: 00353214922603
      • Dublin, Ireland, D24 NR0A
        • Recruiting
        • Tallaght University Hospital ( Site 1551)
        • Contact:
          • Study Coordinator
          • Phone Number: 0035314144209
      • Dublin, Ireland, 8
        • Recruiting
        • St. James's Hospital ( Site 1554)
        • Contact:
          • Study Coordinator
          • Phone Number: 0035314103747
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus ( Site 1603)
        • Contact:
          • Study Coordinator
          • Phone Number: +97247772688
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center ( Site 1601)
        • Contact:
          • Study Coordinator
          • Phone Number: +97226666666
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center ( Site 1605)
        • Contact:
          • Study Coordinator
          • Phone Number: +97226777333
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center ( Site 1606)
        • Contact:
          • Study Coordinator
          • Phone Number: +97297472555
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-35307032
  • Italy
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1656)
        • Contact:
          • Study Coordinator
          • Phone Number: +390223903829
      • Milan, Italy, 20141
        • Recruiting
        • IEO Istituto Europeo di Oncologia ( Site 1655)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390257489482
      • Naples, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1657)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390817770291
      • Padova, Italy, 35128
        • Recruiting
        • IRCCS Istituto Oncologico Veneto ( Site 1654)
        • Contact:
          • Study Coordinator
          • Phone Number: +390498215608
      • Verona, Italy, 37134
        • Recruiting
        • Centro Ricerche Cliniche di Verona ( Site 1659)
        • Contact:
          • Study Coordinator
          • Phone Number: +390458128124
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • Recruiting
        • AOU Renato Dulbecco ( Site 1661)
        • Contact:
          • Study Coordinator
          • Phone Number: 390961883771
    • Emilia-Romagna
      • Ravenna, Emilia-Romagna, Italy, 48121
        • Recruiting
        • Ospedale Santa Maria delle Croci ( Site 1652)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390544285247
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1653)
        • Contact:
          • Study Coordinator
          • Phone Number: +390630154277
    • Roma
      • Rome, Roma, Italy, 00128
        • Recruiting
        • Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1660)
        • Contact:
          • Study Coordinator
          • Phone Number: +3906225411160
      • Rome, Roma, Italy, 00128
        • Recruiting
        • Istituto Nazionale Tumori Regina Elena ( Site 1651)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390652666779
  • Japan
      • Chiba, Japan, 260-8677
        • Recruiting
        • Chiba University Hospital ( Site 1154)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-43-226-2616
      • Fukuoka, Japan, 811-1395
        • Recruiting
        • National Hospital Organization Kyushu Cancer Center ( Site 1167)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-92-541-3231
      • Fukushima, Japan, 960-1295
        • Recruiting
        • Fukushima Medical University Hospital ( Site 1151)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-24-547-1111
      • Hiroshima, Japan, 734-8551
        • Recruiting
        • Hiroshima University Hospital ( Site 1165)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-82-257-5555
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital ( Site 1164)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-86-235-7991
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1161)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6945-1181
      • Wakayama, Japan, 641-8510
        • Recruiting
        • Wakayama Medical University Hospital ( Site 1163)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-73-447-2300
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East ( Site 1155)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-4-7133-1111
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 807-8556
        • Recruiting
        • Hospital of the University of Occupational and Environmental Health, Japan ( Site 1166)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-93-603-1611
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Recruiting
        • St. Marianna University Hospital ( Site 1159)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-44-977-8111
      • Yokohama, Kanagawa, Japan, 241-8515
        • Recruiting
        • Kanagawa Cancer Center ( Site 1158)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-45-520-2222
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital ( Site 1168)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-804-2808
      • Sakai, Osaka, Japan, 590-0197
        • Recruiting
        • Kindai University Hospital ( Site 1162)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-288-7222
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Recruiting
        • Shizuoka Cancer Center ( Site 1160)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-55-989-5222
    • Tochigi
      • Shimotsuga-gun, Tochigi, Japan, 321-0293
        • Recruiting
        • Dokkyo Medical University Hospital ( Site 1152)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-282-86-1111
    • Tokyo
      • Chūō, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital ( Site 1156)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3542-2511
      • Shinjuku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital ( Site 1157)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3342-6111
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • University Medical Center Groningen ( Site 1707)
        • Contact:
          • Study Coordinator
          • Phone Number: +31503616161
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Recruiting
        • Radboudumc ( Site 1706)
        • Contact:
          • Study Coordinator
          • Phone Number: +31 (0)24 3610325
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Recruiting
        • Maastricht UMC+ ( Site 1705)
        • Contact:
          • Study Coordinator
          • Phone Number: +31 (0)43 3875047
    • North Brabant
      • 's-Hertogenbosch, North Brabant, Netherlands, 5223 GZ
        • Recruiting
        • Jeroen Bosch Hospital ( Site 1701)
        • Contact:
          • Study Coordinator
          • Phone Number: +31735532000
    • Provincie Friesland
      • Leeuwarden, Provincie Friesland, Netherlands, 8934 AD
        • Recruiting
        • Frisius Medisch Centrum ( Site 1702)
        • Contact:
          • Study Coordinator
          • Phone Number: +31582866100
    • Utrecht
      • Amersfoort, Utrecht, Netherlands, 3813 TZ
        • Recruiting
        • Meander Medisch Centrum ( Site 1703)
        • Contact:
          • Study Coordinator
          • Phone Number: +31 (0)33 8507843
  • New Zealand
    • Bay of Plenty
      • Tauranga, Bay of Plenty, New Zealand, 3112
        • Recruiting
        • Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 2201)
        • Contact:
          • Study Coordinator
          • Phone Number: +6475798153
    • Otago
      • Dunedin, Otago, New Zealand, 9016
        • Recruiting
        • Dunedin Hospital ( Site 2202)
        • Contact:
          • Study Coordinator
          • Phone Number: +6434740999
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3204
        • Recruiting
        • Waikato Hospital ( Site 2204)
        • Contact:
          • Study Coordinator
          • Phone Number: +6478398976
  • Peru
      • Lima, Peru, 15038
        • Recruiting
        • Detecta Clínica ( Site 2751)
        • Contact:
          • Study Coordinator
          • Phone Number: +51955575199
      • Lima, Peru, 15036
        • Recruiting
        • Aliada ( Site 2753)
        • Contact:
          • Study Coordinator
          • Phone Number: +51990343323
      • Lima, Peru, 15036
        • Recruiting
        • Clínica Internacional - Sede San Borja ( Site 2752)
        • Contact:
          • Study Coordinator
          • Phone Number: +5116196161e5563
      • Lima, Peru, 15036
        • Recruiting
        • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 2755)
        • Contact:
          • Study Coordinator
          • Phone Number: +51951881870
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-569
        • Recruiting
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1763)
        • Contact:
          • Study Coordinator
          • Phone Number: +48616654203
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-202
        • Completed
        • Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 1756)
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-439
        • Recruiting
        • Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii ( Site 1765)
        • Contact:
          • Study Coordinator
          • Phone Number: 782 999 717
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 01-138
        • Recruiting
        • Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 1764)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 22 4312279
    • Podkarpackie Voivodeship
      • Przemyśl, Podkarpackie Voivodeship, Poland, 37-700
        • Recruiting
        • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1759)
        • Contact:
          • Study Coordinator
          • Phone Number: +48166775511
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne ( Site 1758)
        • Contact:
          • Study Coordinator
          • Phone Number: +48583492270
    • Warmian-Masurian Voivodeship
      • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-357
        • Recruiting
        • Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie ( Site 1760)
        • Contact:
          • Study Coordinator
          • Phone Number: +48895322900
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
        • Recruiting
        • Swietokrzyskie Centrum Onkologii. ( Site 1754)
        • Contact:
          • Study Coordinator
          • Phone Number: +48885997850
  • Romania
      • Brasov, Romania, 500052
        • Recruiting
        • S.C. ONCO CARD S.R.L ( Site 1805)
        • Contact:
          • Study Coordinator
          • Phone Number: +40268960
      • Iași, Romania, 700483
        • Recruiting
        • Institutul Regional de Oncologie ( Site 1804)
        • Contact:
          • Study Coordinator
          • Phone Number: 0374278810
    • Bucharest
      • Bucharest, Bucharest, Romania, 010626
        • Recruiting
        • Centrul Medical Medicover Victoria ( Site 1802)
        • Contact:
          • Study Coordinator
          • Phone Number: 219896
    • Timiș County
      • Timișoara, Timiș County, Romania, 300239
        • Recruiting
        • Cabinet Medical Oncomed ( Site 1803)
        • Contact:
          • Study Coordinator
          • Phone Number: +40256495403
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore ( Site 2251)
        • Contact:
          • Study Coordinator
          • Phone Number: +6564368000
      • Singapore, Central Singapore, Singapore, 308433
        • Recruiting
        • Tan Tock Seng Hospital ( Site 2252)
        • Contact:
          • Study Coordinator
          • Phone Number: +65 6256 6011
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 2303)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-2072-2995
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital Yonsei University Health System ( Site 2302)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-2228-0880
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center ( Site 2304)
        • Contact:
          • Study Coordinator
          • Phone Number: +82221489809
      • Seoul, South Korea, 06591
        • Recruiting
        • Seoul St. Mary's Hospital ( Site 2307)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-2258-6045
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, South Korea, 10408
        • Recruiting
        • National Cancer Center ( Site 2305)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-31-920-1694
      • Suwon, Kyonggi-do, South Korea, 16247
        • Recruiting
        • The Catholic University of Korea St. Vincent s Hospital ( Site 2301)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-31-249-8153
      • Suwon, Kyonggi-do, South Korea, 16499
        • Recruiting
        • Ajou University Hospital ( Site 2306)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-31-219-5989
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall D Hebron ( Site 1910)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932746000
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona ( Site 1919)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932275402
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital General Universitario Gregorio Maranon ( Site 1912)
        • Contact:
          • Study Coordinator
          • Phone Number: +34915868115
      • Málaga, Spain, 29004
        • Recruiting
        • Hospital Quiron Malaga ( Site 1914)
        • Contact:
          • Study Coordinator
          • Phone Number: +34951940000
    • Canary Islands
      • Canarias, Canary Islands, Spain, 35016
        • Recruiting
        • Hospital Insular de Gran Canaria ( Site 1911)
        • Contact:
          • Study Coordinator
          • Phone Number: +34928441738
    • La Coruna
      • A Coruña, La Coruna, Spain, 15006
        • Recruiting
        • Complejo Hospitalario Universitario A Coruna ( Site 1916)
        • Contact:
          • Study Coordinator
          • Phone Number: +34981178000292872
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Recruiting
        • Hospital Universitario Quiron Madrid ( Site 1913)
        • Contact:
          • Study Coordinator
          • Phone Number: +34914521987
  • Sweden
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 171 64
        • Recruiting
        • Karolinska Universitetssjukhuset Solna ( Site 1951)
        • Contact:
          • Study Coordinator
          • Phone Number: 46812370000
  • Taiwan
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital ( Site 2358)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-4-22052121x12626
      • Taichung, Taiwan, 40201
        • Recruiting
        • Chung Shan Medical University Hospital ( Site 2351)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-4-24739595
      • Tainan, Taiwan, 704302
        • Recruiting
        • National Cheng Kung University Hospital ( Site 2354)
        • Contact:
          • Study Coordinator
          • Phone Number: +88662353535
      • Taipei, Taiwan, 11030
        • Recruiting
        • Taipei Medical University Hospital ( Site 2352)
        • Contact:
          • Study Coordinator
          • Phone Number: +886227372181
      • Taipei, Taiwan, 104217
        • Recruiting
        • Mackay Memorial Hospital ( Site 2355)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-225433535x2854
      • Taipei, Taiwan, 112
        • Recruiting
        • Koo Foundation Sun Yat-Sen Cancer Center ( Site 2359)
        • Contact:
          • Study Coordinator
          • Phone Number: +886228970011
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital ( Site 2357)
        • Contact:
          • Study Coordinator
          • Phone Number: +886228712121
      • Taipei, Taiwan, 10002
        • Completed
        • National Taiwan University Cancer Center (NTUCC) ( Site 2360)
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital ( Site 2361)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-3-3281200
  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital ( Site 2403)
        • Contact:
          • Study Coordinator
          • Phone Number: +6624141914
      • Ratchathewi, Bangkok, Thailand, 10400
        • Recruiting
        • Ramathibodi Hospital ( Site 2405)
        • Contact:
          • Study Coordinator
          • Phone Number: +6622011671
    • Changwat Khon Kaen
      • Muang, Changwat Khon Kaen, Thailand, 40002
        • Recruiting
        • Faculty of Medicine - Khon Kaen University ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: +6643363746
    • Changwat Songkhla
      • Hat Yai, Changwat Songkhla, Thailand, 90110
        • Recruiting
        • Songklanagarind Hospital ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: +6674451469
    • Chiang Mai
      • Muang, Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakorn Chiang Mai Hospital ( Site 2404)
        • Contact:
          • Study Coordinator
          • Phone Number: +6625790117
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01140
        • Recruiting
        • Adana Medical Park Seyhan Hastanesi ( Site 2010)
        • Contact:
          • Study Coordinator
          • Phone Number: +905393275092
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Sehir Hastanesi ( Site 2002)
        • Contact:
          • Study Coordinator
          • Phone Number: +903125526000
      • Istanbul, Turkey (Türkiye), 34722
        • Recruiting
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2003)
        • Contact:
          • Study Coordinator
          • Phone Number: +902166065200
      • Kayseri, Turkey (Türkiye), 38039
        • Recruiting
        • Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 2009)
        • Contact:
          • Study Coordinator
          • Phone Number: +905388731881
      • Trabzon, Turkey (Türkiye), 61080
        • Recruiting
        • Karadeniz Technical University ( Site 2008)
        • Contact:
          • Study Coordinator
          • Phone Number: 04623775200
    • Ankara
      • Sıhhiye, Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 312 305 50 00
    • Sakarya
      • Adapazarı, Sakarya, Turkey (Türkiye), 54100
        • Recruiting
        • Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2006)
        • Contact:
          • Study Coordinator
          • Phone Number: +905054785576
    • Tekirdas
      • Tekirdağ, Tekirdas, Turkey (Türkiye), 59100
        • Recruiting
        • Namık Kemal University Medical Faculty ( Site 2007)
        • Contact:
          • Study Coordinator
          • Phone Number: +905302073000
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • St James University Hospital ( Site 2055)
        • Contact:
          • Study Coordinator
          • Phone Number: 00441132068225
      • Leicester, United Kingdom, LE1 5WW
        • Recruiting
        • Leicester Royal Infirmary ( Site 2051)
        • Contact:
          • Study Coordinator
          • Phone Number: 00441162585249
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust ( Site 2066)
        • Contact:
          • Study Coordinator
          • Phone Number: 00441614463000
      • Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
        • Recruiting
        • The Clatterbridge Cancer Centre ( Site 2069)
        • Contact:
          • Study Coordinator
          • Phone Number: 00441515565000
      • Portsmouth, United Kingdom, PO6 3LY
        • Recruiting
        • Queen Alexandra Hospital ( Site 2059)
        • Contact:
          • Study Coordinator
          • Phone Number: 02392 286000 x4078
    • Bristol, City of
      • Bristol, Bristol, City of, United Kingdom, BS2 8ED
        • Recruiting
        • Bristol Haematology and Oncology Centre ( Site 2072)
        • Contact:
          • Study Coordinator
          • Phone Number: +441179230000
    • Kensington and Chelsea
      • London, Kensington and Chelsea, United Kingdom, SW3 6JJ
        • Recruiting
        • ROYAL MARSDEN HOSPITAL (CHELSEA)-Lung Unit ( Site 2075)
        • Contact:
          • Study Coordinator
          • Phone Number: 020 7352 8171
    • London, City of
      • London, London, City of, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomews Hospital ( Site 2052)
        • Contact:
          • Study Coordinator
          • Phone Number: 00442073777000
      • London, London, City of, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital ( Site 2074)
        • Contact:
          • Study Coordinator
          • Phone Number: 0207 794 0500
      • London, London, City of, United Kingdom, SE1 3SS
        • Recruiting
        • Guys Hospital ( Site 2057)
        • Contact:
          • Study Coordinator
          • Phone Number: +442071885050
      • London, London, City of, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden Hospital (Sutton) ( Site 2076)
        • Contact:
          • Study Coordinator
          • Phone Number: 020 8642 6011
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham City Hospital ( Site 2058)
        • Contact:
          • Study Coordinator
          • Phone Number: 00441158231851
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner MD Anderson Cancer Center ( Site 0181)
        • Contact:
          • Study Coordinator
          • Phone Number: 480-256-6444
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • The University of Arizona Cancer Center - North Campus ( Site 0163)
        • Contact:
          • Study Coordinator
          • Phone Number: 520-694-2873
    • California
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence St. Jude Medical Center ( Site 0106)
        • Contact:
          • Study Coordinator
          • Phone Number: 714-446-5900
      • Long Beach, California, United States, 90822
        • Recruiting
        • VA Long Beach Healthcare System ( Site 0199)
        • Contact:
          • Study Coordinator
          • Phone Number: 562-826-8000
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC Norris Comprehensive Cancer Center ( Site 0205)
        • Contact:
          • Study Coordinator
          • Phone Number: 323-865-3000
      • Los Angeles, California, United States, 90404
        • Recruiting
        • UCLA Jonsson Comprehensive Cancer Center ( Site 0135)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-825-5268
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Medical Center at Mission Bay ( Site 0178)
        • Contact:
          • Study Coordinator
          • Phone Number: 877-827-3222
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus ( Site 0151)
        • Contact:
          • Study Coordinator
          • Phone Number: 303-724-9690
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • UCHealth Memorial Hospital Central ( Site 0125)
        • Contact:
          • Study Coordinator
          • Phone Number: 719-365-5000
      • Greeley, Colorado, United States, 80631
        • Recruiting
        • Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207)
        • Contact:
          • Study Coordinator
          • Phone Number: 970-810-3894
      • Westminster, Colorado, United States, 80023
        • Recruiting
        • Centura Health - St. Anthony North Health Campus ( Site 0189)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-627-4840
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University School of Medicine ( Site 0201)
        • Contact:
          • Study Coordinator
          • Phone Number: 203-785-7564
      • Norwich, Connecticut, United States, 06360
        • Recruiting
        • Eastern CT Hematology & Oncology Associates ( Site 0202)
        • Contact:
          • Study Coordinator
          • Phone Number: 860-886-8362
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Recruiting
        • The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156)
        • Contact:
          • Study Coordinator
          • Phone Number: 954-771-0692
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute at Baptist Health, Inc. ( Site 0214)
        • Contact:
          • Study Coordinator
          • Phone Number: 786-596-2000
    • Idaho
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Beacon Cancer Care ( Site 0127)
        • Contact:
          • Study Coordinator
          • Phone Number: 208-755-2804
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • The University of Chicago Medical Center ( Site 0118)
        • Contact:
          • Study Coordinator
          • Phone Number: 773-702-2984
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Recruiting
        • Franciscan Health ( Site 0219)
        • Contact:
          • Study Coordinator
          • Phone Number: 317-528-7060
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • Maryland Oncology Hematology (MOH) ( Site 8102)
        • Contact:
          • Study Coordinator
          • Phone Number: 570-808-4772
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital ( Site 0136)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-724-4000
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Hospital ( Site 0155)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-632-3000
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Completed
        • Ellis Fischel Cancer Center ( Site 0133)
      • Osage Beach, Missouri, United States, 65065
        • Completed
        • Lake Regional Hospital-Cancer Center ( Site 0123)
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute ( Site 0184)
        • Contact:
          • Study Coordinator
          • Phone Number: 716-845-3167
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Hematology-Oncology Associates of CNY ( Site 0164)
        • Contact:
          • Study Coordinator
          • Phone Number: 315-472-7504
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai ( Site 0116)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-523-5559
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center ( Site 0137)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-639-2000
      • New York, New York, United States, 10011
        • Recruiting
        • The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216)
        • Contact:
          • Study Coordinator
          • Phone Number: 202-207-2510
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Cancer Center ( Site 0140)
        • Contact:
          • Study Coordinator
          • Phone Number: 315-464-8237
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center ( Site 0160)
        • Contact:
          • Study Coordinator
          • Phone Number: 718-405-8404
      • Valhalla, New York, United States, 10595
        • Recruiting
        • Westchester Medical Center ( Site 0196)
        • Contact:
          • Study Coordinator
          • Phone Number: 914-493-7000
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Weisiger Cancer Insititute ( Site 0266)
        • Contact:
          • Study Coordinator
          • Phone Number: 980-302-6000
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Novant Health Forsyth Medical Center ( Site 0166)
        • Contact:
          • Study Coordinator
          • Phone Number: 336-718-5000
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center ( Site 0119)
        • Contact:
          • Study Coordinator
          • Phone Number: 513-558-2119
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Recruiting
        • Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0217)
        • Contact:
          • Study Coordinator
          • Phone Number: 541-768-4950
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St. Lukes Hospital and Health Network ( Site 0186)
        • Contact:
          • Study Coordinator
          • Phone Number: 484-526-7952
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Recruiting
        • Tennessee Oncology, PLLC - Chattanooga Downtown ( Site 0315)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-961-9469
      • Knoxville, Tennessee, United States, 37916
        • Recruiting
        • Thompson Cancer Survival Center ( Site 0168)
        • Contact:
          • Study Coordinator
          • Phone Number: 865-331-1720
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Elliston Place Medical Oncology & Hematology ( Site 0215)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-961-9469
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology - DFW ( Site 8103)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-370-1987
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center ( Site 0190)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-648-3111
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center ( Site 0150)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-792-6363
      • Houston, Texas, United States, 77030
        • Recruiting
        • O'Quinn Medical Tower at McNair Campus ( Site 0131)
        • Contact:
          • Study Coordinator
          • Phone Number: 832-957-6500
      • Houston, Texas, United States, 77030
        • Recruiting
        • Memorial Hermann Cancer Center ( Site 0172)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-704-3961
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Cancer Center ( Site 0191)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-363-8890
      • Houston, Texas, United States, 77030
        • Recruiting
        • Michael E. DeBakey VA Medical Center ( Site 0197)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-873-200
      • Tyler, Texas, United States, 75701
        • Recruiting
        • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148)
        • Contact:
          • Study Coordinator
          • Phone Number: 903-592-6152
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists ( Site 0167)
        • Contact:
          • Study Coordinator
          • Phone Number: 571-350-8400
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Oncology Associates (VOA) ( Site 8101)
        • Contact:
          • Study Coordinator
          • Phone Number: 757-466-8683
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • VCU Health Adult Outpatient Pavillion ( Site 0193)
        • Contact:
          • Study Coordinator
          • Phone Number: 804-828-7999
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Cancer Institute ( Site 0143)
        • Contact:
          • Study Coordinator
          • Phone Number: 855-922-6237
      • Silverdale, Washington, United States, 98383
        • Recruiting
        • St. Joseph Medical Center Hematology and Oncology - Silverdale ( Site 0192)
        • Contact:
          • Study Coordinator
          • Phone Number: 564-240-3100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable clinical Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) [American Joint Committee on Cancer (AJCC) 8th Edition]
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention
  • Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible
  • Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R])
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor
  • Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
  • Received prior neoadjuvant therapy for their current NSCLC diagnosis
  • Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein [CTLA-4], OX-40, CD137)
  • Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol
  • Received prior treatment with a cancer vaccine
  • Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pembrolizumab + Placebo
For neoadjuvant treatment, participants will receive pembrolizumab 200 mg via IV infusion every 3-week cycle for up to 4 cycles PLUS background chemotherapy via IV infusion (cisplatin 75 mg/m^2 or carboplatin AUC 5 or 6 mg/mL/min, pemetrexed 500 mg/m^2, gemcitabine 1000 mg/m^2, paclitaxel 175 mg/m^2 or 200 mg/m^2 given at a dose and combination per investigator's choice) every 3-week cycle for up to 4 cycles (total neoadjuvant treatment duration of up to ~12 weeks). After surgical resection, for adjuvant treatment, participants will receive pembrolizumab 400 mg via IV infusion every 6-week cycle for up to 7 cycles PLUS matching placebo via IM injection every 3 weeks for up to 9 doses (total adjuvant treatment duration of up to ~42 weeks).
Drug: Paclitaxel
IV infusion
Other Names:
  • Taxol®
  • Onxol®
Drug: Gemcitabine
IV infusion
Other Names:
  • Gemzar
Drug: Carboplatin
IV infusion
Other Names:
  • Paraplatin®
Drug: Pemetrexed
IV infusion
Other Names:
  • Alimta®
Drug: Cisplatin
IV infusion
Other Names:
  • Platinol®
  • Platinol®-AQ
Biological: Pembrolizumab
IV Infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Other: Placebo
IM injection
Experimental: Pembrolizumab + Intismeran autogene
For neoadjuvant treatment, participants will receive pembrolizumab 200 mg via intravenous (IV) infusion every 3-week cycle for up to 4 cycles PLUS background chemotherapy via IV infusion (cisplatin 75 mg/m^2 or carboplatin area under the curve [AUC] 5 or 6 mg/mL/min, pemetrexed 500 mg/m^2, gemcitabine 1000 mg/m^2, paclitaxel 175 mg/m^2 or 200 mg/m^2 given at a dose and combination per investigator's choice) every 3-week cycle for up to 4 cycles (total neoadjuvant treatment duration of up to ~12 weeks). After surgical resection, for adjuvant treatment, participants will receive pembrolizumab 400 mg via IV infusion every 6-week cycle for up to 7 cycles PLUS intismeran autogene 1 mg via intramuscular (IM) injection every 3 weeks for up to 9 doses (total adjuvant treatment duration of up to ~42 weeks).
Drug: Paclitaxel
IV infusion
Other Names:
  • Taxol®
  • Onxol®
Drug: Gemcitabine
IV infusion
Other Names:
  • Gemzar
Drug: Carboplatin
IV infusion
Other Names:
  • Paraplatin®
Drug: Pemetrexed
IV infusion
Other Names:
  • Alimta®
Drug: Cisplatin
IV infusion
Other Names:
  • Platinol®
  • Platinol®-AQ
Biological: Pembrolizumab
IV Infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Biological: Intismeran autogene
IM injection
Other Names:
  • mRNA-4157
  • V940

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival (DFS)
Time Frame: Up to ~97 months
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, as assessed by the investigator, or death due to any cause, whichever occurs first.
Up to ~97 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to ~129 months
OS is defined as the time from randomization to death due to any cause.
Up to ~129 months
Distant Metastasis-Free Survival (DMFS)
Time Frame: Up to ~129 months
DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis as assessed by the investigator, or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor and beyond local tissues and lymph nodes to distant organs or distant lymph nodes.
Up to ~129 months
Disease-Free Survival 2 (DFS2)
Time Frame: Up to ~129 months
DFS2 is defined as the time from randomization to subsequent recurrence or disease progression after initiation of next-line anticancer therapy as assessed by the investigator, or death due to any cause, whichever occurs first.
Up to ~129 months
Lung Cancer Specific Survival (LCSS)
Time Frame: Up to ~129 months
LCSS is defined as the time from randomization to death due to lung cancer specifically as assessed by the investigator.
Up to ~129 months
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30)
Time Frame: Baseline and up to ~129 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" will be scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better overall health status. The change from baseline in global health status/quality of life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.
Baseline and up to ~129 months
Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5)
Time Frame: Baseline and up to ~129 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a worse level of physical functioning. The change from baseline in physical functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.
Baseline and up to ~129 months
Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7)
Time Frame: Baseline and up to ~129 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of role functioning. Change from baseline in the role functioning (EORTC QLQ-C30 Items 6 and 7) combined score will be presented.
Baseline and up to ~129 months
Number of participants with ≥1 adverse event (AE)
Time Frame: Up to ~129 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to ~129 months
Number of participants discontinuing from study therapy due to AE(s)
Time Frame: Up to ~129 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to ~129 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

ModernaTX, Inc.

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2024

Primary Completion (Estimated)

May 16, 2033

Study Completion (Estimated)

January 26, 2038

Study Registration Dates

First Submitted

September 5, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 16, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V940-009
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • U1111-1293-5814 (Registry Identifier: UTN)
  • INTerpath-009 (Other Identifier: MSD)
  • jRCT2061240105 (Registry Identifier: jRCT)
  • 2023-506327-29-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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