AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3NCT06623422

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

A Phase 3 study testing Pembrolizumab, Cisplatin and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC at 244 sites in 31 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Pembrolizumab, Cisplatin and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
680 participants
Where
244 sitesin 31 countries
Study dates
21 Oct 2024to 26 Jan 2038
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

244 sites in 31 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

244 sites in 31 countries

United States54 sites, 52 recruiting

  • University of Colorado Anschutz Medical Campus ( Site 0151)

    Aurora, Colorado, 80045

    Study Coordinator, 303-724-9690

    Recruiting

  • St. Lukes Hospital and Health Network ( Site 0186)

    Bethlehem, Pennsylvania, 18015

    Study Coordinator, 484-526-7952

    Recruiting

  • Massachusetts General Hospital ( Site 0136)

    Boston, Massachusetts, 02114

    Study Coordinator, 617-724-4000

    Recruiting

  • Dana Farber Cancer Hospital ( Site 0155)

    Boston, Massachusetts, 02215

    Study Coordinator, 617-632-3000

    Recruiting

  • Roswell Park Cancer Institute ( Site 0184)

    Buffalo, New York, 14263

    Study Coordinator, 716-845-3167

    Recruiting

  • Novant Health Weisiger Cancer Insititute ( Site 0266)

    Charlotte, North Carolina, 28204

    Study Coordinator, 980-302-6000

    Recruiting

  • Tennessee Oncology, PLLC - Chattanooga Downtown ( Site 0315)

    Chattanooga, Tennessee, 37403

    Study Coordinator, 615-961-9469

    Recruiting

  • The University of Chicago Medical Center ( Site 0118)

    Chicago, Illinois, 60637

    Study Coordinator, 773-702-2984

    Recruiting

  • University of Cincinnati Medical Center ( Site 0119)

    Cincinnati, Ohio, 45219

    Study Coordinator, 513-558-2119

    Recruiting

  • UCHealth Memorial Hospital Central ( Site 0125)

    Colorado Springs, Colorado, 80909

    Study Coordinator, 719-365-5000

    Recruiting

  • Ellis Fischel Cancer Center ( Site 0133)

    Columbia, Missouri, 65212

    Completed

  • Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0217)

    Corvallis, Oregon, 97330

    Study Coordinator, 541-768-4950

    Recruiting

  • Texas Oncology - DFW ( Site 8103)

    Dallas, Texas, 75246

    Study Coordinator, 214-370-1987

    Recruiting

  • UT Southwestern Medical Center ( Site 0190)

    Dallas, Texas, 75390

    Study Coordinator, 214-648-3111

    Recruiting

  • Hematology-Oncology Associates of CNY ( Site 0164)

    East Syracuse, New York, 13057

    Study Coordinator, 315-472-7504

    Recruiting

  • Virginia Cancer Specialists ( Site 0167)

    Fairfax, Virginia, 22031

    Study Coordinator, 571-350-8400

    Recruiting

  • The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156)

    Fort Lauderdale, Florida, 33316

    Study Coordinator, 954-771-0692

    Recruiting

  • Providence St. Jude Medical Center ( Site 0106)

    Fullerton, California, 92835

    Study Coordinator, 714-446-5900

    Recruiting

  • Banner MD Anderson Cancer Center ( Site 0181)

    Gilbert, Arizona, 85234

    Study Coordinator, 480-256-6444

    Recruiting

  • Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207)

    Greeley, Colorado, 80631

    Study Coordinator, 970-810-3894

    Recruiting

  • Houston Methodist Cancer Center ( Site 0191)

    Houston, Texas, 77030

    Study Coordinator, 713-363-8890

    Recruiting

  • MD Anderson Cancer Center ( Site 0150)

    Houston, Texas, 77030

    Study Coordinator, 713-792-6363

    Recruiting

  • Memorial Hermann Cancer Center ( Site 0172)

    Houston, Texas, 77030

    Study Coordinator, 713-704-3961

    Recruiting

  • Michael E. DeBakey VA Medical Center ( Site 0197)

    Houston, Texas, 77030

    Study Coordinator, 713-873-200

    Recruiting

  • O'Quinn Medical Tower at McNair Campus ( Site 0131)

    Houston, Texas, 77030

    Study Coordinator, 832-957-6500

    Recruiting

  • Franciscan Health ( Site 0219)

    Indianapolis, Indiana, 46237

    Study Coordinator, 317-528-7060

    Recruiting

  • Thompson Cancer Survival Center ( Site 0168)

    Knoxville, Tennessee, 37916

    Study Coordinator, 865-331-1720

    Recruiting

  • VA Long Beach Healthcare System ( Site 0199)

    Long Beach, California, 90822

    Study Coordinator, 562-826-8000

    Recruiting

  • USC Norris Comprehensive Cancer Center ( Site 0205)

    Los Angeles, California, 90033

    Study Coordinator, 323-865-3000

    Recruiting

  • UCLA Jonsson Comprehensive Cancer Center ( Site 0135)

    Los Angeles, California, 90404

    Study Coordinator, 310-825-5268

    Recruiting

  • Baptist Clinical Research Institute, Inc. ( Site 9501)

    Memphis, Tennessee, 38120

    Study Coordinator, 800-422-7847

    Recruiting

  • Miami Cancer Institute at Baptist Health, Inc. ( Site 0214)

    Miami, Florida, 33176

    Study Coordinator, 786-596-2000

    Recruiting

  • Elliston Place Medical Oncology & Hematology ( Site 0215)

    Nashville, Tennessee, 37203

    Study Coordinator, 615-961-9469

    Recruiting

  • Yale University School of Medicine ( Site 0201)

    New Haven, Connecticut, 06510

    Study Coordinator, 203-785-7564

    Recruiting

  • The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216)

    New York, New York, 10011

    Study Coordinator, 202-207-2510

    Recruiting

  • Icahn School of Medicine at Mount Sinai ( Site 0116)

    New York, New York, 10029

    Study Coordinator, 212-523-5559

    Recruiting

  • Memorial Sloan Kettering Cancer Center ( Site 0137)

    New York, New York, 10065

    Study Coordinator, 212-639-2000

    Recruiting

  • Virginia Oncology Associates (VOA) ( Site 8101)

    Norfolk, Virginia, 23502

    Study Coordinator, 757-466-8683

    Recruiting

  • Eastern CT Hematology & Oncology Associates ( Site 0202)

    Norwich, Connecticut, 06360

    Study Coordinator, 860-886-8362

    Recruiting

  • Lake Regional Hospital-Cancer Center ( Site 0123)

    Osage Beach, Missouri, 65065

    Completed

  • Illinois Cancer Care ( Site 8107)

    Peoria, Illinois, 61615

    Study Coordinator, 309-243-3627

    Recruiting

  • Beacon Cancer Care ( Site 0127)

    Post Falls, Idaho, 83854

    Study Coordinator, 208-755-2804

    Recruiting

  • VCU Health Adult Outpatient Pavillion ( Site 0193)

    Richmond, Virginia, 23219

    Study Coordinator, 804-828-7999

    Recruiting

  • Maryland Oncology Hematology (MOH) ( Site 8102)

    Rockville, Maryland, 20850

    Study Coordinator, 570-808-4772

    Recruiting

  • UCSF Medical Center at Mission Bay ( Site 0178)

    San Francisco, California, 94158

    Study Coordinator, 877-827-3222

    Recruiting

  • Swedish Cancer Institute ( Site 0143)

    Seattle, Washington, 98104

    Study Coordinator, 855-922-6237

    Recruiting

  • St. Joseph Medical Center Hematology and Oncology - Silverdale ( Site 0192)

    Silverdale, Washington, 98383

    Study Coordinator, 564-240-3100

    Recruiting

  • SUNY Upstate Cancer Center ( Site 0140)

    Syracuse, New York, 13210

    Study Coordinator, 315-464-8237

    Recruiting

  • Montefiore Medical Center ( Site 0160)

    The Bronx, New York, 10461

    Study Coordinator, 718-405-8404

    Recruiting

  • The University of Arizona Cancer Center - North Campus ( Site 0163)

    Tucson, Arizona, 85719

    Study Coordinator, 520-694-2873

    Recruiting

  • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148)

    Tyler, Texas, 75701

    Study Coordinator, 903-592-6152

    Recruiting

  • Westchester Medical Center ( Site 0196)

    Valhalla, New York, 10595

    Study Coordinator, 914-493-7000

    Recruiting

  • Centura Health - St. Anthony North Health Campus ( Site 0189)

    Westminster, Colorado, 80023

    Study Coordinator, 720-627-4840

    Recruiting

  • Novant Health Forsyth Medical Center ( Site 0166)

    Winston-Salem, North Carolina, 27103

    Study Coordinator, 336-718-5000

    Recruiting

Other trials in United States

Japan17 sites, 17 recruiting

  • Chiba University Hospital ( Site 1154)

    Chiba, 260-8677

    Study Coordinator, +81-43-226-2616

    Recruiting

  • National Cancer Center Hospital ( Site 1156)

    Chūō, Tokyo, 104-0045

    Study Coordinator, +81-3-3542-2511

    Recruiting

  • National Hospital Organization Kyushu Cancer Center ( Site 1167)

    Fukuoka, 811-1395

    Study Coordinator, +81-92-541-3231

    Recruiting

  • Fukushima Medical University Hospital ( Site 1151)

    Fukushima, 960-1295

    Study Coordinator, +81-24-547-1111

    Recruiting

  • Kansai Medical University Hospital ( Site 1168)

    Hirakata, Osaka, 573-1191

    Study Coordinator, +81-72-804-2808

    Recruiting

  • Hiroshima University Hospital ( Site 1165)

    Hiroshima, 734-8551

    Study Coordinator, +81-82-257-5555

    Recruiting

  • National Cancer Center Hospital East ( Site 1155)

    Kashiwa, Chiba, 277-8577

    Study Coordinator, +81-4-7133-1111

    Recruiting

  • St. Marianna University Hospital ( Site 1159)

    Kawasaki, Kanagawa, 216-8511

    Study Coordinator, +81-44-977-8111

    Recruiting

  • Hospital of the University of Occupational and Environmental Health, Japan ( Site 1166)

    Kitakyushu, Fukuoka, 807-8556

    Study Coordinator, +81-93-603-1611

    Recruiting

  • Okayama University Hospital ( Site 1164)

    Okayama, 700-8558

    Study Coordinator, +81-86-235-7991

    Recruiting

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1161)

    Osaka, 541-8567

    Study Coordinator, +81-6-6945-1181

    Recruiting

  • Kindai University Hospital ( Site 1162)

    Sakai, Osaka, 590-0197

    Study Coordinator, +81-72-288-7222

    Recruiting

  • Dokkyo Medical University Hospital ( Site 1152)

    Shimotsuga-gun, Tochigi, 321-0293

    Study Coordinator, +81-282-86-1111

    Recruiting

  • Tokyo Medical University Hospital ( Site 1157)

    Shinjuku, Tokyo, 160-0023

    Study Coordinator, +81-3-3342-6111

    Recruiting

  • Shizuoka Cancer Center ( Site 1160)

    Sunto-gun, Shizuoka, 411-8777

    Study Coordinator, +81-55-989-5222

    Recruiting

  • Wakayama Medical University Hospital ( Site 1163)

    Wakayama, 641-8510

    Study Coordinator, +81-73-447-2300

    Recruiting

  • Kanagawa Cancer Center ( Site 1158)

    Yokohama, Kanagawa, 241-8515

    Study Coordinator, +81-45-520-2222

    Recruiting

Other trials in Japan

United Kingdom12 sites, 12 recruiting

  • Bristol Haematology and Oncology Centre ( Site 2072)

    Bristol, Bristol, City of, BS2 8ED

    Study Coordinator, +441179230000

    Recruiting

  • St James University Hospital ( Site 2055)

    Leeds, LS9 7TF

    Study Coordinator, 00441132068225

    Recruiting

  • Leicester Royal Infirmary ( Site 2051)

    Leicester, LE1 5WW

    Study Coordinator, 00441162585249

    Recruiting

  • ROYAL MARSDEN HOSPITAL (CHELSEA)-Lung Unit ( Site 2075)

    London, Kensington and Chelsea, SW3 6JJ

    Study Coordinator, 020 7352 8171

    Recruiting

  • St Bartholomews Hospital ( Site 2052)

    London, London, City of, EC1A 7BE

    Study Coordinator, 00442073777000

    Recruiting

  • Royal Free Hospital ( Site 2074)

    London, London, City of, NW3 2QG

    Study Coordinator, 0207 794 0500

    Recruiting

  • Guys Hospital ( Site 2057)

    London, London, City of, SE1 3SS

    Study Coordinator, +442071885050

    Recruiting

  • Royal Marsden Hospital (Sutton) ( Site 2076)

    London, London, City of, SW3 6JJ

    Study Coordinator, 020 8642 6011

    Recruiting

  • The Christie NHS Foundation Trust ( Site 2066)

    Manchester, M20 4BX

    Study Coordinator, 00441614463000

    Recruiting

  • The Clatterbridge Cancer Centre ( Site 2069)

    Metropolitan Borough of Wirral, CH63 4JY

    Study Coordinator, 00441515565000

    Recruiting

  • Nottingham City Hospital ( Site 2058)

    Nottingham, Nottinghamshire, NG5 1PB

    Study Coordinator, 00441158231851

    Recruiting

  • Queen Alexandra Hospital ( Site 2059)

    Portsmouth, PO6 3LY

    Study Coordinator, 02392 286000 x4078

    Recruiting

Other trials in United Kingdom

Brazil10 sites, 10 recruiting

  • Hospital de Amor - Barretos ( Site 2511)

    Barretos, São Paulo, 14784-400

    Study Coordinator, +551733216638

    Recruiting

  • Hospital Tacchini ( Site 2506)

    Bento Gonçalves, Rio Grande do Sul, 95700-000

    Study Coordinator, 555434554333x1125

    Recruiting

  • CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 2502)

    Fortaleza, Ceará, 60336-550

    Study Coordinator, +5585991372979

    Recruiting

  • Hospital Araújo Jorge ( Site 2514)

    Goiânia, Goiás, 74605070

    Study Coordinator, +55 062 99339-2208

    Recruiting

  • Liga Norte Riograndense Contra o Cancer ( Site 2513)

    Natal, Rio Grande do Norte, 59062-000

    Study Coordinator, +558440095595

    Recruiting

  • Hospital de Clínicas de Passo Fundo ( Site 2504)

    Passo Fundo, Rio Grande do Sul, 99010-260

    Study Coordinator, +555421033490

    Recruiting

  • Hospital Moinhos de Vento ( Site 2510)

    Porto Alegre, Rio Grande do Sul, 90035-001

    Study Coordinator, +55 51 99604-4976

    Recruiting

  • Hospital Nossa Senhora Da Conceicao ( Site 2512)

    Porto Alegre, Rio Grande do Sul, 91359-200

    Study Coordinator, +555133572092

    Recruiting

  • Instituto Nacional de Câncer - INCA ( Site 2501)

    Rio de Janeiro, 20230-130

    Study Coordinator, +552132076564

    Recruiting

  • Instituto de Oncologia Saint Gallen ( Site 2507)

    Santa Cruz do Sul, Rio Grande do Sul, 96830-180

    Study Coordinator, +555130568686

    Recruiting

Other trials in Brazil

Italy10 sites, 10 recruiting

  • AOU Renato Dulbecco ( Site 1661)

    Catanzaro, Calabria, 88100

    Study Coordinator, 390961883771

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1656)

    Milan, 20133

    Study Coordinator, +390223903829

    Recruiting

  • IEO Istituto Europeo di Oncologia ( Site 1655)

    Milan, 20141

    Study Coordinator, 00390257489482

    Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1657)

    Naples, 80131

    Study Coordinator, 00390817770291

    Recruiting

  • IRCCS Istituto Oncologico Veneto ( Site 1654)

    Padova, 35128

    Study Coordinator, +390498215608

    Recruiting

  • Ospedale Santa Maria delle Croci ( Site 1652)

    Ravenna, Emilia-Romagna, 48121

    Study Coordinator, 00390544285247

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1653)

    Rome, Lazio, 00168

    Study Coordinator, +390630154277

    Recruiting

  • Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1660)

    Rome, Roma, 00128

    Study Coordinator, +3906225411160

    Recruiting

  • Istituto Nazionale Tumori Regina Elena ( Site 1651)

    Rome, Roma, 00128

    Study Coordinator, 00390652666779

    Recruiting

  • Centro Ricerche Cliniche di Verona ( Site 1659)

    Verona, 37134

    Study Coordinator, +390458128124

    Recruiting

Other trials in Italy

Taiwan9 sites, 8 recruiting

  • Chung Shan Medical University Hospital ( Site 2351)

    Taichung, 40201

    Study Coordinator, +886-4-24739595

    Recruiting

  • China Medical University Hospital ( Site 2358)

    Taichung, 40447

    Study Coordinator, 886-4-22052121x12626

    Recruiting

  • National Cheng Kung University Hospital ( Site 2354)

    Tainan, 704302

    Study Coordinator, +88662353535

    Recruiting

  • National Taiwan University Cancer Center (NTUCC) ( Site 2360)

    Taipei, 10002

    Completed

  • Mackay Memorial Hospital ( Site 2355)

    Taipei, 104217

    Study Coordinator, 886-225433535x2854

    Recruiting

  • Taipei Medical University Hospital ( Site 2352)

    Taipei, 11030

    Study Coordinator, +886227372181

    Recruiting

  • Koo Foundation Sun Yat-Sen Cancer Center ( Site 2359)

    Taipei, 112

    Study Coordinator, +886228970011

    Recruiting

  • Taipei Veterans General Hospital ( Site 2357)

    Taipei, 112

    Study Coordinator, +886228712121

    Recruiting

  • Chang Gung Memorial Hospital ( Site 2361)

    Taoyuan, 333

    Study Coordinator, +886-3-3281200

    Recruiting

Other trials in Taiwan

France8 sites, 7 recruiting

  • CHU Besançon ( Site 1358)

    Besançon, Franche-Comte, 25000

    Completed

  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1359)

    Caen, Basse-Normandie, 14033

    Study Coordinator, +33 2 31 06 43 88

    Recruiting

  • Institut Cœur Poumon -CHU Lille ( Site 1352)

    Lille, Nord, 59037

    Study Coordinator, +333.20.44.59.62

    Recruiting

  • CENTRE LEON BERARD ( Site 1351)

    Lyon, Rhone, 69008

    Study Coordinator, +33478782828

    Recruiting

  • Pitie Salpetriere University Hospital ( Site 1355)

    Paris, 75013

    Study Coordinator, 33142160508

    Recruiting

  • Institut De Cancerologie De L Ouest ( Site 1357)

    Saint-Herblain, Loire-Atlantique, 44800

    Study Coordinator, +33240679900

    Recruiting

  • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 1354)

    Tours, Centre-Val de Loire, 3700

    Study Coordinator, 33247478701

    Recruiting

  • Gustave Roussy ( Site 1353)

    Villejuif, Île-de-France Region, 94805

    Study Coordinator, + 33 1 42 11 67 78

    Recruiting

Other trials in France

Germany8 sites, 8 recruiting

  • St.-Antonius-Hospital ( Site 1411)

    Eschweiler, North Rhine-Westphalia, 52249

    Study Coordinator, 0049 2403-761737

    Recruiting

  • UKGM Gießen/Marburg ( Site 1404)

    Giessen, Hesse, 35392

    Study Coordinator, 004964198543591

    Recruiting

  • Thoraxklinik-Heidelberg gGmbH ( Site 1412)

    Heidelberg, Baden-Wurttemberg, 69126

    Study Coordinator, +4962213961350

    Recruiting

  • Klinikverbund Allgäu gGmbH ( Site 1408)

    Kempten (Allgäu), Bavaria, 87439

    Study Coordinator, +49 0831 530 1934

    Recruiting

  • Marienhaus Klinikum Mainz ( Site 1403)

    Mainz, Rhineland-Palatinate, 55131

    Study Coordinator, 0049 6131/57583 2406

    Recruiting

  • Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 1405)

    Münster, North Rhine-Westphalia, 48149

    Study Coordinator, +49 251 83-52712

    Recruiting

  • Pius Hospital Oldenburg ( Site 1407)

    Oldenburg, Lower Saxony, 26121

    Study Coordinator, +494412291611

    Recruiting

  • Robert-Bosch-Krankenhaus ( Site 1401)

    Stuttgart, Baden-Wurttemberg, 70376

    Study Coordinator, 0049 711 8101-7757

    Recruiting

Other trials in Germany

Greece8 sites, 8 recruiting

  • Errikos Dunant Hospital Center ( Site 1457)

    Athens, Attica, 115 26

    Study Coordinator, 0030 2106972246

    Recruiting

  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1451)

    Athens, Attica, 115 27

    Study Coordinator, 0030 2107700220

    Recruiting

  • Metropolitan Hospital ( Site 1459)

    Athens, Attica, 185 47

    Study Coordinator, 0030 2104807106

    Recruiting

  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1460)

    Chaïdári, Attica, 124 62

    Study Coordinator, 0030 2313301848

    Recruiting

  • University General Hospital of Herakleion ( Site 1458)

    Heraklion, Irakleio, 715 00

    Study Coordinator, 0030 2810392091

    Recruiting

  • University General Hospital of Larissa-Oncology Clinic ( Site 1453)

    Larissa, Thessaly, 411 10

    Study Coordinator, 0030 2413501636

    Recruiting

  • UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1452)

    Pátrai, Achaia, 265 04

    Study Coordinator, 0030 2613603791

    Recruiting

  • Papageorgiou General Hospital of Thessaloniki ( Site 1454)

    Thessaloniki, 564 29

    Study Coordinator, 0030 2313323867

    Recruiting

Other trials in Greece

Hungary8 sites, 7 recruiting

  • Orszagos Koranyi Pulmonologiai Intezet ( Site 1501)

    Budapest, 1121

    Study Coordinator, +3613913213

    Recruiting

  • Debreceni Egyetem Altalanos Orvostudomanyi Kar Tudogyogyaszati Tanszek ( Site 1508)

    Debrecen, Hajdú-Bihar, 4032

    Completed

  • Petz Aladár Megyei Oktató Kórház ( Site 1502)

    Győr, Győr-Moson-Sopron, 9024

    Study Coordinator, +36704454354

    Recruiting

  • Somogy Vármegyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1507)

    Kaposvár, Somogy County, 7400

    Study Coordinator, +3682501300/1669

    Recruiting

  • Mátrai Gyógyintézet ( Site 1504)

    Mátraháza, Heves County, 3233

    Study Coordinator, +36 37 574 500

    Recruiting

  • Nograd Varmegyei Szent Lazar Korhaz ( Site 1509)

    Salgótarján, Nógrád megye, 3100

    Study Coordinator, +3632522000

    Recruiting

  • Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 1506)

    Székesfehérvár, Fejér, 8000

    Study Coordinator, (06 22) 535 500

    Recruiting

  • Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1505)

    Törökbálint, Pest County, 2045

    Study Coordinator, +36307005601

    Recruiting

Other trials in Hungary

Poland8 sites, 6 recruiting

  • Uniwersyteckie Centrum Kliniczne ( Site 1758)

    Gdansk, Pomeranian Voivodeship, 80-214

    Completed

  • Swietokrzyskie Centrum Onkologii. ( Site 1754)

    Kielce, Świętokrzyskie Voivodeship, 25-734

    Study Coordinator, +48885997850

    Recruiting

  • Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 1756)

    Krakow, Lesser Poland Voivodeship, 31-202

    Completed

  • Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie ( Site 1760)

    Olsztyn, Warmian-Masurian Voivodeship, 10-357

    Study Coordinator, +48895322900

    Recruiting

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1763)

    Poznan, Greater Poland Voivodeship, 60-569

    Study Coordinator, +48616654203

    Recruiting

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1759)

    Przemyśl, Podkarpackie Voivodeship, 37-700

    Study Coordinator, +48166775511

    Recruiting

  • Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 1764)

    Warsaw, Masovian Voivodeship, 01-138

    Study Coordinator, +48 22 4312279

    Recruiting

  • Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii ( Site 1765)

    Wroclaw, Lower Silesian Voivodeship, 53-439

    Study Coordinator, 782 999 717

    Recruiting

Other trials in Poland

Turkey (Türkiye)8 sites, 8 recruiting

  • Adana Medical Park Seyhan Hastanesi ( Site 2010)

    Adana, 01140

    Study Coordinator, +905393275092

    Recruiting

  • Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2006)

    Adapazarı, Sakarya, 54100

    Study Coordinator, +905054785576

    Recruiting

  • Ankara Bilkent Sehir Hastanesi ( Site 2002)

    Ankara, 06800

    Study Coordinator, +903125526000

    Recruiting

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2003)

    Istanbul, 34722

    Study Coordinator, +902166065200

    Recruiting

  • Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 2009)

    Kayseri, 38039

    Study Coordinator, +905388731881

    Recruiting

  • Hacettepe Universite Hastaneleri ( Site 2001)

    Sıhhiye, Ankara, 06230

    Study Coordinator, +90 312 305 50 00

    Recruiting

  • Namık Kemal University Medical Faculty ( Site 2007)

    Tekirdağ, Tekirdas, 59100

    Study Coordinator, +905302073000

    Recruiting

  • Karadeniz Technical University ( Site 2008)

    Trabzon, 61080

    Study Coordinator, 04623775200

    Recruiting

Other trials in Turkey (Türkiye)

Canada7 sites, 7 recruiting

  • Queen Elizabeth II Health Sciences Centre ( Site 1101)

    Halifax, Nova Scotia, B3H 2Y9

    Study Coordinator, 9024738317

    Recruiting

  • Hamilton Health Sciences - Juravinski Site ( Site 1104)

    Hamilton, Ontario, L8V 5C2

    Study Coordinator, 9053879495

    Recruiting

  • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1105)

    Kingston, Ontario, K7L 2V7

    Study Coordinator, 6135496666

    Recruiting

  • McGill University Health Centre ( Site 1103)

    Montreal, Quebec, H4A 3J1

    Study Coordinator, 5149341934

    Recruiting

  • Lakeridge Health ( Site 1107)

    Oshawa, Ontario, L1G 2B9

    Study Coordinator, 905-576-8711x32802

    Recruiting

  • IUCPQ ( Site 1112)

    Québec, Quebec, G1V 4G5

    Study Coordinator, 4186568711

    Recruiting

  • Sunnybrook Research Institute ( Site 1106)

    Toronto, Ontario, M4N 3M5

    Study Coordinator, 4164806100

    Recruiting

Other trials in Canada

South Korea7 sites, 7 recruiting

  • National Cancer Center ( Site 2305)

    Goyang-si, Kyonggi-do, 10408

    Study Coordinator, +82-31-920-1694

    Recruiting

  • Seoul National University Hospital ( Site 2303)

    Seoul, 03080

    Study Coordinator, +82-2-2072-2995

    Recruiting

  • Severance Hospital Yonsei University Health System ( Site 2302)

    Seoul, 03722

    Study Coordinator, +82-2-2228-0880

    Recruiting

  • Samsung Medical Center ( Site 2304)

    Seoul, 06351

    Study Coordinator, +82221489809

    Recruiting

  • Seoul St. Mary's Hospital ( Site 2307)

    Seoul, 06591

    Study Coordinator, +82-2-2258-6045

    Recruiting

  • The Catholic University of Korea St. Vincent s Hospital ( Site 2301)

    Suwon, Kyonggi-do, 16247

    Study Coordinator, +82-31-249-8153

    Recruiting

  • Ajou University Hospital ( Site 2306)

    Suwon, Kyonggi-do, 16499

    Study Coordinator, +82-31-219-5989

    Recruiting

Other trials in South Korea

Spain7 sites, 7 recruiting

  • Complejo Hospitalario Universitario A Coruna ( Site 1916)

    A Coruña, La Coruna, 15006

    Study Coordinator, +34981178000292872

    Recruiting

  • Hospital Universitari Vall D Hebron ( Site 1910)

    Barcelona, 08035

    Study Coordinator, +34932746000

    Recruiting

  • Hospital Clinic de Barcelona ( Site 1919)

    Barcelona, 08036

    Study Coordinator, +34932275402

    Recruiting

  • Hospital Insular de Gran Canaria ( Site 1911)

    Canarias, Canary Islands, 35016

    Study Coordinator, +34928441738

    Recruiting

  • Hospital General Universitario Gregorio Maranon ( Site 1912)

    Madrid, 28009

    Study Coordinator, +34915868115

    Recruiting

  • Hospital Quiron Malaga ( Site 1914)

    Málaga, 29004

    Study Coordinator, +34951940000

    Recruiting

  • Hospital Universitario Quiron Madrid ( Site 1913)

    Pozuelo de Alarcón, Madrid, 28223

    Study Coordinator, +34914521987

    Recruiting

Other trials in Spain

Argentina6 sites, 6 recruiting

  • Fundacion Intecnus ( Site 2456)

    Bariloche, Río Negro Province, R8402APU

    Study Coordinator, 0294154293757

    Recruiting

  • Instituto Medico Especializado Alexander Fleming ( Site 2457)

    Buenos Aires, C1426ANZ

    Study Coordinator, +541132218900

    Recruiting

  • CEMIC ( Site 2454)

    Caba., Buenos Aires, C1431FWO

    Study Coordinator, 5411529901002543

    Recruiting

  • Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2459)

    Ciudad Autonoma de Buenos Aires., Buenos Aires, C1199ABB

    Study Coordinator, 49590200

    Recruiting

  • Instituto Oncologico de Cordoba -IONC ( Site 2455)

    Córdoba, X5001HWE

    Study Coordinator, 5493516165267

    Recruiting

  • Centro Médico IPAM ( Site 2452)

    Rosario, Santa Fe Province, S2001SBK

    Study Coordinator, +543414858585

    Recruiting

Other trials in Argentina

Chile6 sites, 6 recruiting

  • Bradford Hill Norte ( Site 2563)

    Antofagasta, 1263521

    Study Coordinator, +56552655924

    Recruiting

  • Orlandi Oncologia ( Site 2555)

    Santiago, Region M. de Santiago, 7500713

    Study Coordinator, 56226057491

    Recruiting

  • Fundación Arturo López Pérez ( Site 2551)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, 56224205098

    Recruiting

  • Clínica RedSalud Vitacura ( Site 2556)

    Santiago, Region M. de Santiago, 7650018

    Study Coordinator, 56223954044

    Recruiting

  • Bradfordhill ( Site 2552)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, 56229490970

    Recruiting

  • ONCOCENTRO APYS ( Site 2554)

    Viña del Mar, Valparaiso, 2520598

    Study Coordinator, 56323320850

    Recruiting

Other trials in Chile

Colombia6 sites, 5 recruiting

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 2603)

    Bogotá, Bogota D.C., 110131

    Study Coordinator, +573016348173

    Recruiting

  • Hospital Universitario San Ignacio ( Site 2610)

    Bogotá, Bogota D.C., 110231

    Study Coordinator, 573108658288

    Recruiting

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 2604)

    Bogotá, Bogota D.C., 111321

    Study Coordinator, 573103130894

    Recruiting

  • Fundacion Valle del Lili- CIC ( Site 2601)

    Cali, Valle del Cauca Department, 760032

    Completed

  • IMAT S.A.S ( Site 2602)

    Montería, Departamento de Córdoba, 230002

    Study Coordinator, +573135342052

    Recruiting

  • Oncologos del Occidente ( Site 2608)

    Pereira, Risaralda Department, 660001

    Study Coordinator, +573187715522

    Recruiting

Other trials in Colombia

Netherlands6 sites, 6 recruiting

  • Jeroen Bosch Hospital ( Site 1701)

    's-Hertogenbosch, North Brabant, 5223 GZ

    Study Coordinator, +31735532000

    Recruiting

  • Meander Medisch Centrum ( Site 1703)

    Amersfoort, Utrecht, 3813 TZ

    Study Coordinator, +31 (0)33 8507843

    Recruiting

  • University Medical Center Groningen ( Site 1707)

    Groningen, 9713 GZ

    Study Coordinator, +31503616161

    Recruiting

  • Frisius Medisch Centrum ( Site 1702)

    Leeuwarden, Provincie Friesland, 8934 AD

    Study Coordinator, +31582866100

    Recruiting

  • Maastricht UMC+ ( Site 1705)

    Maastricht, Limburg, 6229 HX

    Study Coordinator, +31 (0)43 3875047

    Recruiting

  • Radboudumc ( Site 1706)

    Nijmegen, Gelderland, 6525 GA

    Study Coordinator, +31 (0)24 3610325

    Recruiting

Other trials in Netherlands

Australia5 sites, 4 recruiting

  • Grampians Health ( Site 2101)

    Ballarat, Victoria, 3350

    Study Coordinator, 61(03)53208500

    Recruiting

  • One Clinical Research ( Site 2103)

    Nedlands, Western Australia, 6009

    Study Coordinator, 0061862799466

    Recruiting

  • Tasman Oncology Research ( Site 2104)

    Southport, Queensland, 4215

    Completed

  • Calvary Mater Newcastle ( Site 2106)

    Waratah, New South Wales, 2298

    Study Coordinator, 61240143584

    Recruiting

  • Princess Alexandra Hospital ( Site 2102)

    Woolloongabba, Queensland, 4102

    Study Coordinator, 0061731763515

    Recruiting

Other trials in Australia

Israel5 sites, 5 recruiting

  • Rambam Health Care Campus ( Site 1603)

    Haifa, 3109601

    Study Coordinator, +97247772688

    Recruiting

  • Shaare Zedek Medical Center ( Site 1601)

    Jerusalem, 9103102

    Study Coordinator, +97226666666

    Recruiting

  • Hadassah Medical Center ( Site 1605)

    Jerusalem, 9112001

    Study Coordinator, +97226777333

    Recruiting

  • Meir Medical Center ( Site 1606)

    Kfar Saba, 4428164

    Study Coordinator, +97297472555

    Recruiting

  • Sheba Medical Center ( Site 1602)

    Ramat Gan, 5265601

    Study Coordinator, +972-35307032

    Recruiting

Other trials in Israel

Thailand5 sites, 5 recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 2403)

    Bangkoknoi, Bangkok, 10700

    Study Coordinator, +6624141914

    Recruiting

  • Songklanagarind Hospital ( Site 2402)

    Hat Yai, Changwat Songkhla, 90110

    Study Coordinator, +6674451469

    Recruiting

  • Faculty of Medicine - Khon Kaen University ( Site 2401)

    Muang, Changwat Khon Kaen, 40002

    Study Coordinator, +6643363746

    Recruiting

  • Maharaj Nakorn Chiang Mai Hospital ( Site 2404)

    Muang, Chiang Mai, 50200

    Study Coordinator, +6625790117

    Recruiting

  • Ramathibodi Hospital ( Site 2405)

    Ratchathewi, Bangkok, 10400

    Study Coordinator, +6622011671

    Recruiting

Other trials in Thailand

Peru4 sites, 4 recruiting

  • Aliada ( Site 2753)

    Lima, 15036

    Study Coordinator, +51990343323

    Recruiting

  • Clínica Internacional - Sede San Borja ( Site 2752)

    Lima, 15036

    Study Coordinator, +5116196161e5563

    Recruiting

  • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 2755)

    Lima, 15036

    Study Coordinator, +51951881870

    Recruiting

  • Detecta Clínica ( Site 2751)

    Lima, 15038

    Study Coordinator, +51955575199

    Recruiting

Other trials in Peru

Romania4 sites, 4 recruiting

  • S.C. ONCO CARD S.R.L ( Site 1805)

    Brasov, 500052

    Study Coordinator, +40268960

    Recruiting

  • Centrul Medical Medicover Victoria ( Site 1802)

    Bucharest, Bucharest, 010626

    Study Coordinator, 219896

    Recruiting

  • Institutul Regional de Oncologie ( Site 1804)

    Iași, 700483

    Study Coordinator, 0374278810

    Recruiting

  • Cabinet Medical Oncomed ( Site 1803)

    Timișoara, Timiș County, 300239

    Study Coordinator, +40256495403

    Recruiting

Other trials in Romania

Belgium3 sites, 3 recruiting

  • Cliniques Universitaires Saint-Luc ( Site 1203)

    Brussels, Bruxelles-Capitale, Region de, 1200

    Study Coordinator, +32.2.764.79.25

    Recruiting

  • UZ Gent ( Site 1201)

    Ghent, Oost-Vlaanderen, 9000

    Study Coordinator, +32 9 332 59 11

    Recruiting

  • Jessa Ziekenhuis ( Site 1204)

    Hasselt, Limburg, 3500

    Study Coordinator, +32 11 33 50 23

    Recruiting

Other trials in Belgium

Ireland3 sites, 3 recruiting

  • Cork University Hospital ( Site 1553)

    Cork, T12 E8YV

    Study Coordinator, 00353214922603

    Recruiting

  • St. James's Hospital ( Site 1554)

    Dublin, 8

    Study Coordinator, 0035314103747

    Recruiting

  • Tallaght University Hospital ( Site 1551)

    Dublin, D24 NR0A

    Study Coordinator, 0035314144209

    Recruiting

Other trials in Ireland

New Zealand3 sites, 2 recruiting

  • Dunedin Hospital ( Site 2202)

    Dunedin, Otago, 9016

    Study Coordinator, +6434740999

    Recruiting

  • Waikato Hospital ( Site 2204)

    Hamilton, Waikato Region, 3204

    Study Coordinator, +6478398976

    Recruiting

  • Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 2201)

    Tauranga, Bay of Plenty, 3112

    Completed

Other trials in New Zealand

Bulgaria2 sites, 2 recruiting

  • MBAL Uni Hospital ( Site 1253)

    Panagyurishte, Pazardzhik, 4500

    Study Coordinator, +35935788581

    Recruiting

  • MHAT - Heart and Brain ( Site 1252)

    Pleven, 5800

    Study Coordinator, +35964678400

    Recruiting

Other trials in Bulgaria

Finland2 sites, 2 recruiting

  • Oulun yliopistollinen sairaala ( Site 1301)

    Oulu, Northern Savonia, 90220

    Study Coordinator, +35883153789

    Recruiting

  • Turku University Hospital ( Site 1303)

    Turku, Southwest Finland, 20520

    Study Coordinator, +35823138709

    Recruiting

Other trials in Finland

Singapore2 sites, 2 recruiting

  • National Cancer Centre Singapore ( Site 2251)

    Singapore, Central Singapore, 168583

    Study Coordinator, +6564368000

    Recruiting

  • Tan Tock Seng Hospital ( Site 2252)

    Singapore, Central Singapore, 308433

    Study Coordinator, +65 6256 6011

    Recruiting

Other trials in Singapore

Sweden1 site, 1 recruiting

  • Karolinska Universitetssjukhuset Solna ( Site 1951)

    Stockholm, Stockholm County, 171 64

    Study Coordinator, 46812370000

    Recruiting

Other trials in Sweden

About this study

Official title: 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).

Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2), Individualized neoantigen therapy (INT)
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    IV Infusion

  • CisplatinDrug

    Also called Platinol®, Platinol®-AQ

    IV infusion

  • CarboplatinDrug

    Also called Paraplatin®

    IV infusion

  • PemetrexedDrug

    Also called Alimta®

    IV infusion

  • GemcitabineDrug

    Also called Gemzar

    IV infusion

  • PaclitaxelDrug

    Also called Taxol®, Onxol®

    IV infusion

  • Intismeran autogeneBiological

    Also called mRNA-4157, V940

    IM injection

  • PlaceboOther

    IM injection

Study groups in NCT06623422
Study groupRoleWhat they receive
Pembrolizumab + Intismeran autogeneExperimentalFor 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).
Receives: Biological: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Gemcitabine; Drug: Paclitaxel; Biological: Intismeran autogene
Pembrolizumab + PlaceboActive comparatorFor 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).
Receives: Biological: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Gemcitabine; Drug: Paclitaxel; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-Free Survival (DFS)

    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.

    Measured: Up to ~97 months

Secondary outcomes (9)

  1. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to ~129 months

  2. Distant Metastasis-Free Survival (DMFS)

    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.

    Measured: Up to ~129 months

  3. Disease-Free Survival 2 (DFS2)

    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.

    Measured: Up to ~129 months

  4. Lung Cancer Specific Survival (LCSS)

    LCSS is defined as the time from randomization to death due to lung cancer specifically as assessed by the investigator.

    Measured: Up to ~129 months

  5. 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)

    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.

    Measured: Baseline and up to ~129 months

  6. Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5)

    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.

    Measured: Baseline and up to ~129 months

  7. Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7)

    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.

    Measured: Baseline and up to ~129 months

  8. Number of participants with ≥1 adverse event (AE)

    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.

    Measured: Up to ~129 months

  9. Number of participants discontinuing from study therapy due to AE(s)

    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.

    Measured: Up to ~129 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2024
  2. Study start21 Oct 2024
  3. Primary completion16 May 2033 (estimated)
  4. Study completion26 Jan 2038 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
680 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06623422
Sponsor's protocol ID
V940-009
Other IDs
2023-506327-29-00, U1111-1293-5814, INTerpath-009, jRCT2061240105, 2023
Status last verified
Oct 2026
First submitted
5 Sep 2024
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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