A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)

June 11, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)

This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses:

Hypothesis 1: Combination of calderasib and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

Hypothesis 2: Combination of calderasib plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

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
      • CABA, Buenos Aires, Argentina, C1019ABS
        • Completed
        • AUSTRAL MEDICAL CENTER ( Site 0302)
      • CABA, Buenos Aires, Argentina, C1426AGE
        • Recruiting
        • Centro Oncologico Korben ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: 1157507952
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Recruiting
        • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)
        • Contact:
          • Study Coordinator
          • Phone Number: 02234963224
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DEJ
        • Recruiting
        • Fundacion Estudios Clinicos ( Site 0306)
        • Contact:
          • Study Coordinator
          • Phone Number: +543412221472
      • Rosario, Santa Fe Province, Argentina, S2000DSV
        • Recruiting
        • Sanatorio Parque ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: +54341420-0222
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Chris O'Brien Lifehouse ( Site 3000)
        • Contact:
          • Study Coordinator
          • Phone Number: +61285140140
    • Queensland
      • Urraween, Queensland, Australia, 4655
        • Recruiting
        • Cancer Care Service Hervey Bay ( Site 3003)
        • Contact:
          • Study Coordinator
          • Phone Number: +610743256110
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Frankston Hospital ( Site 3002)
        • Contact:
          • Study Coordinator
          • Phone Number: +61397847777
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • One Clinical Research ( Site 3001)
        • Contact:
          • Study Coordinator
          • Phone Number: +61862799466
  • Austria
      • Vienna, Austria, 1210
        • Recruiting
        • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2400)
        • Contact:
          • Study Coordinator
          • Phone Number: 0043 1 27700 72212
    • Styria
      • Graz, Styria, Austria, 8036
        • Recruiting
        • Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: 004331638512183
  • Brazil
      • Rio de Janeiro, Brazil, 22775-001
        • Recruiting
        • Americas ( Site 0431)
        • Contact:
          • Study Coordinator
          • Phone Number: +552133852088
      • Rio de Janeiro, Brazil, 20230-130
        • Recruiting
        • Instituto Nacional de Câncer - INCA ( Site 0446)
        • Contact:
          • Study Coordinator
          • Phone Number: +552132076564
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30380-472
        • Recruiting
        • Hospital Mario Penna ( Site 0436)
        • Contact:
          • Study Coordinator
          • Phone Number: +553132999543
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50040-000
        • Recruiting
        • Hospital de Câncer de Recife ( Site 0447)
        • Contact:
          • Study Coordinator
          • Phone Number: +558132178084
    • Piauí
      • Teresina, Piauí, Brazil, 64049-200
        • Recruiting
        • Oncoclínica Oncologistas Associados ( Site 0441)
        • Contact:
          • Study Coordinator
          • Phone Number: +558631945000
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59062-000
        • Recruiting
        • Liga Norte Riograndense Contra o Câncer ( Site 0439)
        • Contact:
          • Study Coordinator
          • Phone Number: +558440095595
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700 000
        • Recruiting
        • Hospital de Caridade de Ijuí ( Site 0438)
        • Contact:
          • Study Coordinator
          • Phone Number: +5555991221138
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010-260
        • Recruiting
        • Hospital de Clínicas de Passo Fundo ( Site 0442)
        • Contact:
          • Study Coordinator
          • Phone Number: +5554981271411
      • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
        • Recruiting
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro Multidisciplinar de Pesquisa Clínica ( Site 0435)
        • Contact:
          • Study Coordinator
          • Phone Number: +555132148143
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Recruiting
        • Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0437)
        • Contact:
          • Study Coordinator
          • Phone Number: +551733216638
  • Bulgaria
      • Pleven, Bulgaria, 5804
        • Recruiting
        • MHAT - Heart and Brain ( Site 1006)
        • Contact:
          • Study Coordinator
          • Phone Number: +35988030371
      • Plovdiv, Bulgaria, 4000
        • Recruiting
        • Medical Center Futuremeds ( Site 1007)
        • Contact:
          • Study Coordinator
          • Phone Number: +359886744494
      • Plovdiv, Bulgaria, 4004
        • Recruiting
        • Complex Oncology Center - Plovdiv EOOD ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: +359 32 277 240
    • Pazardzhik
      • Panagyurishte, Pazardzhik, Bulgaria, 4500
        • Recruiting
        • MBAL Uni Hospital-Department of Medical Oncology ( Site 1000)
        • Contact:
          • Study Coordinator
          • Phone Number: +35935788581
    • Sofia (stolitsa)
      • Sofia, Sofia (stolitsa), Bulgaria, 1632
        • Recruiting
        • Multiprofile Hospital for Active Treatment SerdikaМЕD EOOD-Second Department of Medical Oncology ( Site 1002)
        • Contact:
          • Study Coordinator
          • Phone Number: +35929049100
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Recruiting
        • CancerCare Manitoba ( Site 0210)
        • Contact:
          • Study Coordinator
          • Phone Number: 204-787-4156
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Recruiting
        • QEII Health Sciences Centre - Victoria General Site-Dept. of Medical Oncology ( Site 0208)
        • Contact:
          • Study Coordinator
          • Phone Number: 9024737964
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0205)
        • Contact:
          • Study Coordinator
          • Phone Number: 9053879495
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute ( Site 0206)
        • Contact:
          • Study Coordinator
          • Phone Number: 4164805000x687435
    • Quebec
      • Montreal, Quebec, Canada, H3T 1M5
        • Recruiting
        • St. Marys Hospital Center ( Site 0204)
        • Contact:
          • Study Coordinator
          • Phone Number: 5143453511
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • Recruiting
        • Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0207)
        • Contact:
          • Study Coordinator
          • Phone Number: 8196973333x63238
  • Chile
    • Maule Region
      • Talca, Maule Region, Chile, 3465584
        • Recruiting
        • Clinica Universidad Catolica del Maule-Oncology ( Site 0500)
        • Contact:
          • Study Coordinator
          • Phone Number: +56947532700
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500713
        • Recruiting
        • Orlandi Oncologia-Oncology ( Site 0503)
        • Contact:
          • Study Coordinator
          • Phone Number: +56226057491
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP-UIDO ( Site 0501)
        • Contact:
          • Study Coordinator
          • Phone Number: +56224205098
      • Santiago, Region M. de Santiago, Chile, 7560908
        • Recruiting
        • Centro de Oncología de Precisión-Oncology ( Site 0502)
        • Contact:
          • Study Coordinator
          • Phone Number: +56225189885
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill-Clinical Area ( Site 0504)
        • Contact:
          • Study Coordinator
          • Phone Number: +56229490970
  • China
    • Anhui
      • Hefei, Anhui, China, 230031
        • Recruiting
        • Anhui Provincial Cancer Hospital ( Site 3136)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 055165327626
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer hospital ( Site 3133)
        • Contact:
          • Study Coordinator
          • Phone Number: +8601088196497
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer hospital ( Site 3134)
        • Contact:
          • Study Coordinator
          • Phone Number: +8601088121122
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Beijing Peking Union Medical College Hospital-pneumology department ( Site 3102)
        • Contact:
          • Study Coordinator
          • Phone Number: 86-10-69151188
      • Beijing, Beijing Municipality, China, 101149
        • Recruiting
        • Beijing Chest Hospital,Capital Medical University ( Site 3104)
        • Contact:
          • Study Coordinator
          • Phone Number: 861089500153
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Recruiting
        • Chongqing University Cancer Hospital ( Site 3119)
        • Contact:
          • Study Coordinator
          • Phone Number: 15123117697
      • Chongqing, Chongqing Municipality, China, 400042
        • Recruiting
        • Army Medical Center of People's Liberation Army ( Site 3142)
        • Contact:
          • Study Coordinator
          • Phone Number: 13113931434
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital ( Site 3127)
        • Contact:
          • Study Coordinator
          • Phone Number: 0591-62002053
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated hospital of Xiamen University ( Site 3148)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 13860458889
    • Guangdong
      • Guangzhou, Guangdong, China, 510160
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University ( Site 3108)
        • Contact:
          • Study Coordinator
          • Phone Number: 13710249454
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University Nanfang Hospital ( Site 3128)
        • Contact:
          • Study Coordinator
          • Phone Number: 020-61641575
      • Guangzhou, Guangdong, China, 510555
        • Recruiting
        • Sun Yat-sen University Cancer Center ( Site 3137)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 13928791406
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital ( Site 3123)
        • Contact:
          • Study Coordinator
          • Phone Number: 0451-86298000
      • Jiamusi, Heilongjiang, China, 154007
        • Recruiting
        • JIAMUSI TUBERCULOSIS HOSPITAL(CANCER HOSPITAL) ( Site 3124)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613704540727
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital ( Site 3149)
        • Contact:
          • Study Coordinator
          • Phone Number: 15713837082
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Tongji Hospital Tongji Medical,Science & Technology ( Site 3113)
        • Contact:
          • Study Coordinator
          • Phone Number: 027-83663312
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital ( Site 3126)
        • Contact:
          • Study Coordinator
          • Phone Number: 027-87670291
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital ( Site 3141)
        • Contact:
          • Study Coordinator
          • Phone Number: 0731-89762320
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University ( Site 3130)
        • Contact:
          • Study Coordinator
          • Phone Number: 0731-85295929
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Gulou Hospital ( Site 3122)
        • Contact:
          • Study Coordinator
          • Phone Number: 025-83106666
      • Nanjing, Jiangsu, China, 210012
        • Active, not recruiting
        • Nanjing First Hospital ( Site 3154)
      • Suzhou, Jiangsu, China, 215006
        • Completed
        • The First Affiliated Hospital of Soochow University ( Site 3146)
      • Wuxi, Jiangsu, China, 214122
        • Recruiting
        • Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3155)
        • Contact:
          • Study Coordinator
          • Phone Number: 0510-88682999
    • Jiangxi
      • Nanchang, Jiangxi, China, 330209
        • Recruiting
        • The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 3138)
        • Contact:
          • Study Coordinator
          • Phone Number: 079186319333
      • Nanchang, Jiangxi, China, 330000
        • Active, not recruiting
        • The Second Affiliated Hospital of Nanchang University ( Site 3139)
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • Jilin Province Tumor Hospital ( Site 3107)
        • Contact:
          • Study Coordinator
          • Phone Number: 86-431-80596607
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 3150)
        • Contact:
          • Study Coordinator
          • Phone Number: 8602985324935
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital ( Site 3116)
        • Contact:
          • Study Coordinator
          • Phone Number: 053187984777
      • Linyi, Shandong, China, 276001
        • Recruiting
        • LinYi Cancer Hospital ( Site 3111)
        • Contact:
          • Study Coordinator
          • Phone Number: 0539-8125078
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Recruiting
        • Shanghai Chest Hospital ( Site 3100)
        • Contact:
          • Study Coordinator
          • Phone Number: 86021222000005455
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center ( Site 3144)
        • Contact:
          • Study Coordinator
          • Phone Number: 02164175590
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Zhongshan Hospital,Fudan University ( Site 3143)
        • Contact:
          • Study Coordinator
          • Phone Number: 021-64041990-692331
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Recruiting
        • Shanxi Cancer Hospital ( Site 3131)
        • Contact:
          • Study Coordinator
          • Phone Number: 0351-4651523
      • Xian, Shanxi, China, 710038
        • Recruiting
        • The Second Affiliated Hospital of Air Force Medical University ( Site 3152)
        • Contact:
          • Study Coordinator
          • Phone Number: 02984777777
      • Xian, Shanxi, China, 710038
        • Active, not recruiting
        • The Second Affiliated Hospital of Air Force Medical University ( Site 3117)
    • Sichuan
      • Chengdu, Sichuan, China, 610031
        • Recruiting
        • The Third People's Hospital of Chengdu (CDTPH) ( Site 3157)
        • Contact:
          • Study Coordinator
          • Phone Number: 028-61318530
      • Chengdu, Sichuan, China, 610042
        • Recruiting
        • Sichuan Cancer hospital. ( Site 3109)
        • Contact:
          • Study Coordinator
          • Phone Number: 028-60670301
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • West China Hospital, Sichuan University ( Site 3140)
        • Contact:
          • Study Coordinator
          • Phone Number: +8618980606625
      • Neijiang, Sichuan, China, 641000
        • Recruiting
        • The Second People's Hospital of Neijiang ( Site 3105)
        • Contact:
          • Study Coordinator
          • Phone Number: 0832-2383101
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Completed
        • Xinjiang Medical University Cancer Hospital - Urumqi ( Site 3101)
    • Yunnan
      • Kunming, Yunnan, China, 650107
        • Recruiting
        • Yunnan Province Cancer Hospital ( Site 3153)
        • Contact:
          • Study Coordinator
          • Phone Number: 0871-68103376
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 3121)
        • Contact:
          • Study Coordinator
          • Phone Number: 0571-86090073
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3115)
        • Contact:
          • Study Coordinator
          • Phone Number: 0571-87236114
      • Linhai, Zhejiang, China, 317000
        • Recruiting
        • Taizhou Hospital of Zhejiang Province ( Site 3145)
        • Contact:
          • Study Coordinator
          • Phone Number: 86057685199810
      • Wenzhou, Zhejiang, China, 325015
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University ( Site 3151)
        • Contact:
          • Study Coordinator
          • Phone Number: 0577-55578166
  • France
    • Bourgogne-Franche-Comté
      • Dijon, Bourgogne-Franche-Comté, France, 21000
        • Recruiting
        • Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: +33380293772
    • Gard
      • Nîmes, Gard, France, 30029
        • Recruiting
        • Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire ( Site 1106)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 4 66 68 32 21
    • Nord
      • Valenciennes, Nord, France, 59304
        • Recruiting
        • Clinique Teissier Groupe ( Site 1100)
        • Contact:
          • Study Coordinator
          • Phone Number: +33327142337
    • Puy-de-Dome
      • Clermont-Ferrand, Puy-de-Dome, France, 63003
        • Recruiting
        • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: +33473278005
    • Vaucluse
      • Avignon, Vaucluse, France, 84000
        • Recruiting
        • Centre Hospitalier d'Avignon-Service d'Oncologie médicale et d'hématologie clinique ( Site 1104)
        • Contact:
          • Study Coordinator
          • Phone Number: +33432753333
    • Île-de-France Region
      • Boulogne-Billancourt, Île-de-France Region, France, 92100
        • Recruiting
        • Hôpital Ambroise Paré-Department of Respiratory Diseases and Thoracic Oncology ( Site 1105)
        • Contact:
          • Study Coordinator
          • Phone Number: +33149095806
  • Georgia
      • Tbilisi, Georgia, 0112
        • Recruiting
        • Todua Clinic, LLC ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: +995322575757
      • Tbilisi, Georgia, 0162
        • Recruiting
        • New Hospitals ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: +995 598 988 566
      • Tbilisi, Georgia, 0177
        • Recruiting
        • Cancer Research Centre. Mardaleishvili Medical Centre ( Site 1205)
        • Contact:
          • Study Coordinator
          • Phone Number: +995322430100
      • Tbilisi, Georgia, 0102
        • Recruiting
        • American Hospital Network LLC ( Site 1208)
        • Contact:
          • Study Coordinator
          • Phone Number: +995 571 300 705
      • Tbilisi, Georgia, 1206
        • Completed
        • Tbilisi Institute of Medicine ( Site 1206)
      • Tbilisi, Georgia, 0144
        • Completed
        • TSMU and Ingorokva High Medical Technology University Clinic LTD ( Site 1201)
    • Adjara
      • Batumi, Adjara, Georgia, 6000
        • Recruiting
        • High Technology Hospital Medcenter ( Site 1203)
        • Contact:
          • Study Coordinator
          • Phone Number: +995596226060
      • Tbilisi, Adjara, Georgia, 0186
        • Recruiting
        • Caucasus Medical Centre ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: +995 597 550 140
  • Germany
    • Baden-Wurttemberg
      • Stuttgart, Baden-Wurttemberg, Germany, 70199
        • Recruiting
        • Marienhospital Stuttgart ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: +49711064893273
    • North Rhine-Westphalia
      • Bielefeld, North Rhine-Westphalia, Germany, 33611
        • Recruiting
        • Evangelisches Krankenhaus Bielefeld - Johannesstift ( Site 1307)
        • Contact:
          • Study Coordinator
          • Phone Number: 0521 772 75504
      • Solingen, North Rhine-Westphalia, Germany, 42699
        • Recruiting
        • Krankenhaus Bethanien ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: +49212636661
  • Greece
      • Thessaloniki, Greece, 570 10
        • Recruiting
        • G. Papanikolaou General Hospital-Pulmonary Clinic of Aristotle University of Thessaloniki ( Site 1405)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 231330787476
      • Thessaloniki, Greece, 552 36
        • Recruiting
        • Agios Loukas Clinic ( Site 1404)
        • Contact:
          • Study Coordinator
          • Phone Number: +302310380000
    • Achaia
      • Pátrai, Achaia, Greece, 26504
        • Recruiting
        • UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: +302610999791
    • Attica
      • Athens, Attica, Greece, 115 27
        • Recruiting
        • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1400)
        • Contact:
          • Study Coordinator
          • Phone Number: +302107700220
      • Athens, Attica, Greece, 115 22
        • Recruiting
        • Agios Savvas Regional Cancer Hospital-2nd Medical Oncology Department ( Site 1407)
        • Contact:
          • Study Coordinator
          • Phone Number: +302106409501
      • Marousi, Attica, Greece, 151 25
        • Recruiting
        • Athens Medical Center ( Site 1406)
        • Contact:
          • Study Coordinator
          • Phone Number: +302107464642
    • Thessaly
      • Larissa, Thessaly, Greece, 411 10
        • Recruiting
        • University General Hospital of Larissa-Oncology Clinic ( Site 1403)
        • Contact:
          • Study Coordinator
          • Phone Number: +302413502124
  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400004
        • Recruiting
        • Sir H. N. Reliance Foundation Hospital and Research Centre ( Site 3201)
        • Contact:
          • Study Coordinator
          • Phone Number: +91-9619607339
      • Mumbai, Maharashtra, India, 400012
        • Recruiting
        • Tata Memorial Hospital ( Site 3205)
        • Contact:
          • Study Coordinator
          • Phone Number: 02224177000
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110076
        • Recruiting
        • Indraprastha Apollo Hospitals-APOLLO RESEARCH INNOVATION ( Site 3203)
        • Contact:
          • Study Coordinator
          • Phone Number: +919426166688
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • Recruiting
        • AIIMS New Delhi Dept of Medicine ( Site 3206)
        • Contact:
          • Study Coordinator
          • Phone Number: +91-9650629370
  • Italy
      • Padova, Italy, 35131
        • Recruiting
        • IOV - Istituto Oncologico Veneto IRCCS UOSD - Unità di ricerca clinica ( Site 1603)
        • Contact:
          • Study Coordinator
          • Phone Number: +390498215649
    • Campania
      • Naples, Campania, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia clinica sperimentale Toraco-Polmonare ( Site 1607)
        • Contact:
          • Study Coordinator
          • Phone Number: +390811777029
    • Emilia-Romagna
      • Ravenna, Emilia-Romagna, Italy, 48121
        • Recruiting
        • Ospedale Santa Maria delle Croci ( Site 1606)
        • Contact:
          • Study Coordinator
          • Phone Number: +390544285247
    • Friuli Venezia Giulia
      • Aviano, Friuli Venezia Giulia, Italy, 33081
        • Recruiting
        • CRO-IRCCS-Clinical Oncology ( Site 1605)
        • Contact:
          • Study Coordinator
          • Phone Number: +390434309464
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1601)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390630156318
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1600)
        • Contact:
          • Study Coordinator
          • Phone Number: +390223903829
      • Milan, Lombardy, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1604)
        • Contact:
          • Study Coordinator
          • Phone Number: +390257489482
    • Napoli
      • Naples, Napoli, Italy, 80131
        • Recruiting
        • A.O.R.N. Ospedale dei Colli - Monaldi V.-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: 0817062652
    • Roma
      • Rome, Roma, Italy, 00144
        • Recruiting
        • Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1609)
        • Contact:
          • Study Coordinator
          • Phone Number: +390652662205
    • Tuscany
      • Livorno, Tuscany, Italy, 57124
        • Recruiting
        • Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno-UOC Oncologia Medica Livorno ( Site 1608)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390586223416
  • Japan
      • Chiba, Japan, 260-8677
        • Recruiting
        • Chiba University Hospital ( Site 3322)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-43-222-7171
      • Hiroshima, Japan, 730-8518
        • Recruiting
        • Hiroshima City Hiroshima Citizens Hospital ( Site 3314)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-82-221-2291
      • Kumamoto, Japan, 861-4193
        • Recruiting
        • Saiseikai Kumamoto Hospital ( Site 3318)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-96-351-8000
      • Niigata, Japan, 951-8520
        • Recruiting
        • Niigata University Medical & Dental Hospital ( Site 3323)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-25-223-6161
      • Osaka, Japan, 545-8586
        • Recruiting
        • Osaka Metropolitan University Hospital ( Site 3321)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6645-2121
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Recruiting
        • Nagoya University Hospital ( Site 3309)
        • Contact:
          • Study Coordinator
          • Phone Number: ＋81-52-741-2111
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Recruiting
        • Fujita Health University Hospital ( Site 3310)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-562-93-2111
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East ( Site 3303)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-4-7133-1111
    • Ehime
      • Matsuyam, Ehime, Japan, 719-0280
        • Recruiting
        • National Hospital Organization Shikoku Cancer Center ( Site 3315)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-89-999-1111
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 811-1395
        • Recruiting
        • National Hospital Organization Kyushu Cancer Center ( Site 3316)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-92-541-3231
      • Kurume, Fukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital ( Site 3317)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-942-35-3311
    • Gunma
      • Ōta, Gunma, Japan, 373-8550
        • Recruiting
        • Gunma Prefectural Cancer Center ( Site 3302)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-276-38-0771
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Recruiting
        • Sapporo Medical University Hospital ( Site 3324)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-11-611-2111
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital ( Site 3308)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-76-265-2000
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Recruiting
        • St. Marianna University Hospital ( Site 3320)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-44-977-8111
    • Mie-ken
      • Matsusaka, Mie-ken, Japan, 515-8544
        • Recruiting
        • Saiseikai Matsusaka Municipal Hospital ( Site 3311)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-598-23-1515
    • Miyagi
      • Natori-shi, Miyagi, Japan, 981-1293
        • Recruiting
        • Miyagi Cancer Center ( Site 3301)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-22-384-3151
      • Sendai, Miyagi, Japan, 981-0914
        • Recruiting
        • Sendai Kousei Hospital ( Site 3300)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-22-222-6181
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital ( Site 3312)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-804-0101
      • Takatsuki, Osaka, Japan, 569-8686
        • Recruiting
        • Osaka Medical and Pharmaceutical University Hospital ( Site 3313)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-683-1221
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Recruiting
        • Saitama Prefectural Cancer Center ( Site 3304)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-48-722-1111
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8603
        • Recruiting
        • Nippon Medical School Hospital ( Site 3306)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3822-2131
      • Shinjuku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital ( Site 3307)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3342-6111
      • Shinjuku, Tokyo, Japan, 162-8655
        • Recruiting
        • National Center for Global Health and Medicine ( Site 3305)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3202-7181
      • Ōta-ku, Tokyo, Japan, 143-8541
        • Recruiting
        • Toho University Omori Medical Center ( Site 3319)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3762-4151
  • Mexico
      • Oaxaca City, Mexico, 68000
        • Recruiting
        • Oaxaca Site Management Organization S.C. ( Site 0603)
        • Contact:
          • Study Coordinator
          • Phone Number: +529515147056
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06700
        • Recruiting
        • Arké SMO S.A. de C.V. ( Site 0602)
        • Contact:
          • Study Coordinator
          • Phone Number: 5533345856
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 66460
        • Recruiting
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 0600)
        • Contact:
          • Study Coordinator
          • Phone Number: +528180883663
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • Universitair Medisch Centrum Utrecht ( Site 1704)
        • Contact:
          • Study Coordinator
          • Phone Number: 00318875555555
    • Gelderland
      • Ede, Gelderland, Netherlands, 6716 RP
        • Recruiting
        • Ziekenhuis Gelderse Vallei ( Site 1705)
        • Contact:
          • Study Coordinator
          • Phone Number: 0318435499
      • Harderwijk, Gelderland, Netherlands, 3844 DG
        • Recruiting
        • Ziekenhuis St. Jansdal-Poli Longziekten ( Site 1701)
        • Contact:
          • Study Coordinator
          • Phone Number: 0031341463504
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025 AB
        • Recruiting
        • Isala, locatie Zwolle-Poli Longziekten ( Site 1700)
        • Contact:
          • Study Coordinator
          • Phone Number: 0031886243254
  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • Auckland City Hospital ( Site 3400)
        • Contact:
          • Study Coordinator
          • Phone Number: +6493074949
  • Philippines
    • National Capital Region
      • Pasig, National Capital Region, Philippines, 1600
        • Recruiting
        • The Medical City ( Site 3507)
        • Contact:
          • Study Coordinator
          • Phone Number: (02)6356789 loc 5083
      • Quezon City, National Capital Region, Philippines, 1100
        • Recruiting
        • Lung Center of the Philippines-Pulmonary, Critical Care and Sleep Medicine ( Site 3503)
        • Contact:
          • Study Coordinator
          • Phone Number: +632 892 46101*1309
      • Quezon City, National Capital Region, Philippines, 1100
        • Recruiting
        • Veterans Memorial Medical Center-Section of Oncology ( Site 3505)
        • Contact:
          • Study Coordinator
          • Phone Number: +63289276426
      • Quezon City, National Capital Region, Philippines, 1102
        • Recruiting
        • ST. LUKE'S MEDICAL CENTER-Medical oncology ( Site 3501)
        • Contact:
          • Study Coordinator
          • Phone Number: +63287230101
  • Poland
    • Lesser Poland Voivodeship
      • Gorlice, Lesser Poland Voivodeship, Poland, 38-300
        • Active, not recruiting
        • Szpital Specjalistyczny im. Henryka Klimontowicza ( Site 1801)
      • Krakow, Lesser Poland Voivodeship, Poland, 30-727
        • Recruiting
        • Pratia MCM Krakow ( Site 1808)
        • Contact:
          • Study Coordinator
          • Phone Number: 48122954139
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-090
        • Recruiting
        • Uniwersytecki Szpital Kliniczny nr 4 w Lublinie ( Site 1805)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 814485180
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 1800)
        • Contact:
          • Study Coordinator
          • Phone Number: +48225462336
    • Podkarpackie Voivodeship
      • Przemyśl, Podkarpackie Voivodeship, Poland, 37-700
        • Recruiting
        • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1804)
        • Contact:
          • Study Coordinator
          • Phone Number: +48166775000
    • Warmian-Masurian Voivodeship
      • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-357
        • Recruiting
        • Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie ( Site 1809)
        • Contact:
          • Study Coordinator
          • Phone Number: +48895322978
  • Romania
      • Brasov, Romania, 500052
        • Recruiting
        • SC ONCO CARD SRL ( Site 1995)
        • Contact:
          • Study Coordinator
          • Phone Number: +40268 994
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • Institutul Oncologic Cluj-Oncologie Medicala ( Site 1999)
        • Contact:
          • Study Coordinator
          • Phone Number: +40264598362
      • Suceava, Romania, 720214
        • Recruiting
        • Sigmedical Services SRL ( Site 1997)
        • Contact:
          • Study Coordinator
          • Phone Number: +4 0330 803 483
    • Bucharest
      • Bucharest, Bucharest, Romania, 020335
        • Recruiting
        • Centrul de Diagnostic si Tratament Provita. ( Site 1992)
        • Contact:
          • Study Coordinator
          • Phone Number: +4021.9432
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • Recruiting
        • Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1994)
        • Contact:
          • Study Coordinator
          • Phone Number: +40731604432
    • Timiș County
      • Timișoara, Timiș County, Romania, 300239
        • Recruiting
        • Cabinet Medical Oncomed ( Site 1998)
        • Contact:
          • Study Coordinator
          • Phone Number: +40356460995
  • South Korea
      • Incheon, South Korea, 22332
        • Recruiting
        • Inha University Hospital ( Site 3610)
        • Contact:
          • Study Coordinator
          • Phone Number: +82328901038
      • Seoul, South Korea, 02447
        • Recruiting
        • Kyung Hee University Hospital ( Site 3605)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-958-8511
      • Seoul, South Korea, 08308
        • Recruiting
        • Korea University Guro Hospital ( Site 3601)
        • Contact:
          • Study Coordinator
          • Phone Number: +82226261914
      • Seoul, South Korea, 03312
        • Recruiting
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3608)
        • Contact:
          • Study Coordinator
          • Phone Number: +82220304340
      • Seoul, South Korea, 02841
        • Recruiting
        • Korea University Anam Hospital ( Site 3609)
        • Contact:
          • Study Coordinator
          • Phone Number: +8229206409
    • Incheon
      • Bupyeong-gu, Incheon, South Korea, 21431
        • Recruiting
        • The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 3606)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-32-280-6474
    • Jeonranamdo
      • Hwasun, Jeonranamdo, South Korea, 58128
        • Completed
        • Chonnam National University Hwasun Hospital-Pulmonology ( Site 3604)
    • Kyonggi-do
      • Suwon, Kyonggi-do, South Korea, 16247
        • Recruiting
        • The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3600)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-31-244-7983
    • Kyongsangnam-do
      • Yangsan, Kyongsangnam-do, South Korea, 50612
        • Recruiting
        • Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3603)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-55-360-1415
    • Taegu-Kwangyokshi
      • Daegu, Taegu-Kwangyokshi, South Korea, 42601
        • Recruiting
        • Keimyung University Dongsan Hospital ( Site 3611)
        • Contact:
          • Study Coordinator
          • Phone Number: +82532587737
      • Daegu, Taegu-Kwangyokshi, South Korea, 42415
        • Recruiting
        • Yeungnam University Hospital ( Site 3607)
        • Contact:
          • Study Coordinator
          • Phone Number: +82536203848
    • Taejon-Kwangyokshi
      • Junggu, Taejon-Kwangyokshi, South Korea, 35015
        • Recruiting
        • Chungnam national university hospital ( Site 3602)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-42-257-5753
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d Hebron ( Site 2010)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 932 543 450
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 2017)
        • Contact:
          • Study Coordinator
          • Phone Number: 34915504800x253900
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario La Princesa ( Site 2020)
        • Contact:
          • Study Coordinator
          • Phone Number: +34915202200
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria ( Site 2021)
        • Contact:
          • Study Coordinator
          • Phone Number: 0034671594566
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2015)
        • Contact:
          • Study Coordinator
          • Phone Number: 34954712941
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35001
        • Recruiting
        • Hospital Insular de Gran Canaria-Oncology ( Site 2019)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 928441738
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28009
        • Recruiting
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2012)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 915868115
    • Malaga
      • Málaga, Malaga, Spain, 29011
        • Recruiting
        • H.R.U Málaga - Hospital General-Oncology ( Site 2014)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 951308130
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01140
        • Recruiting
        • Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2107)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 322 456 19 00
      • Ankara, Turkey (Türkiye), 06010
        • Recruiting
        • SBU GULHANE EGITIM VE ARASTIRMA HASTANESI Onkoloji ( Site 2104)
        • Contact:
          • Study Coordinator
          • Phone Number: +905058726378
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri-oncology hospital ( Site 2101)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 312 305 10 80
      • Ankara, Turkey (Türkiye), 06520
        • Recruiting
        • Memorial Ankara Hastanesi-Medical Oncology ( Site 2106)
        • Contact:
          • Study Coordinator
          • Phone Number: +903122536666
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi ( Site 2100)
        • Contact:
          • Study Coordinator
          • Phone Number: +903125526000
      • Istanbul, Turkey (Türkiye), 34214
        • Recruiting
        • Medipol Mega Universite Hastanesi-oncology ( Site 2105)
        • Contact:
          • Study Coordinator
          • Phone Number: +902124447044
      • Istanbul, Turkey (Türkiye), 34722
        • Recruiting
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2103)
        • Contact:
          • Study Coordinator
          • Phone Number: +902166065200
    • İzmir
      • Bornova, İzmir, Turkey (Türkiye), 35100
        • Recruiting
        • Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2102)
        • Contact:
          • Study Coordinator
          • Phone Number: +905322202675
  • Ukraine
    • Cherkasy Oblast
      • Cherkasy, Cherkasy Oblast, Ukraine, 18009
        • Active, not recruiting
        • COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 2209)
    • Chernivetska Oblast
      • Chernivtsi, Chernivetska Oblast, Ukraine, 58013
        • Recruiting
        • Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 2210)
        • Contact:
          • Study Coordinator
          • Phone Number: +380955077568
    • Dnipropetrovsk Oblast
      • Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine, 50000
        • Recruiting
        • Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2215)
        • Contact:
          • Study Coordinator
          • Phone Number: +380973567855
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
        • Recruiting
        • Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 2202)
        • Contact:
          • Study Coordinator
          • Phone Number: +380978411455
    • Kirovohrad Oblast
      • Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25011
        • Recruiting
        • Kirovohrad Regional Oncology Center-Chemotherapy department ( Site 2204)
        • Contact:
          • Study Coordinator
          • Phone Number: +380508412400
    • Kyivska Oblast
      • Kiev, Kyivska Oblast, Ukraine, 03022
        • Recruiting
        • Medical Center "MedOffice Group" ( Site 2219)
        • Contact:
          • Study Coordinator
          • Phone Number: +380503858689
    • Lviv Oblast
      • Lviv, Lviv Oblast, Ukraine, 79059
        • Recruiting
        • Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2217)
        • Contact:
          • Study Coordinator
          • Phone Number: +380506749772
    • Rivne Oblast
      • Rivne, Rivne Oblast, Ukraine, 33007
        • Completed
        • Rivne Regional Clinical Hospital ( Site 2205)
      • Rivne, Rivne Oblast, Ukraine, 33010
        • Recruiting
        • ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2920)
        • Contact:
          • Study Coordinator
          • Phone Number: +380362633075
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21029
        • Recruiting
        • Communal Noncommercial Enterprise "Podillia Regional Oncolog-Cardiothoracic department ( Site 2211)
        • Contact:
          • Study Coordinator
          • Phone Number: +380953105783
    • Volyn Oblast
      • Lutsk, Volyn Oblast, Ukraine, 43018
        • Recruiting
        • ME Volyn Regional Clinical Hospital of the Volyn Regional Council ( Site 2216)
        • Contact:
          • Study Coordinator
          • Phone Number: +380503782998
  • United Kingdom
    • Buckinghamshire
      • Milton Keynes, Buckinghamshire, United Kingdom, MK6 5LD
        • Recruiting
        • Milton Keynes Hospital ( Site 2304)
        • Contact:
          • Study Coordinator
          • Phone Number: 01908 997609
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Recruiting
        • Royal Devon & Exeter Hospital-Oncology ( Site 2302)
        • Contact:
          • Study Coordinator
          • Phone Number: +44 (0) 1392 402869
  • United States
    • California
      • Bakersfield, California, United States, 93309
        • Recruiting
        • CBCC Global Research, Inc. ( Site 0123)
        • Contact:
          • Study Coordinator
          • Phone Number: 661-322-2206
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Beverly Hills Cancer Center ( Site 0116)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-432-8955
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • Recruiting
        • Stamford Hospital ( Site 0136)
        • Contact:
          • Study Coordinator
          • Phone Number: 877-233-9355
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Completed
        • Mount Sinai Cancer Center ( Site 0137)
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Recruiting
        • Orchard Healthcare Research Inc. ( Site 0115)
        • Contact:
          • Study Coordinator
          • Phone Number: 224-534-7580
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Truman Medical Center ( Site 0126)
        • Contact:
          • Study Coordinator
          • Phone Number: 816-404-4093
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • Cox Medical Center North ( Site 0133)
        • Contact:
          • Study Coordinator
          • Phone Number: 417-875-3000
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • St. Vincent Frontier Cancer Center-Research ( Site 0105)
        • Contact:
          • Study Coordinator
          • Phone Number: 402-238-6685
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Atlantic Health System Morristown Medical Center ( Site 0121)
        • Contact:
          • Study Coordinator
          • Phone Number: 973-275-7788
    • New York
      • Albany, New York, United States, 12206
        • Recruiting
        • New York Oncology Hematology, P.C. ( Site 0132)
        • Contact:
          • Study Coordinator
          • Phone Number: 518-489-3612
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103)
        • Contact:
          • Study Coordinator
          • Phone Number: 513-556-6000
      • Kettering, Ohio, United States, 45429
        • Completed
        • Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106)
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • Recruiting
        • Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0134)
        • Contact:
          • Study Coordinator
          • Phone Number: 717-544-9400
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Oncology Consultants P.A. ( Site 0113)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-600-0900
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Recruiting
        • Circuit Clinical/SSM Health Dean Medical Group ( Site 0129)
        • Contact:
          • Study Coordinator
          • Phone Number: 608-410-2767

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

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

Inclusion Criteria:

  • Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
  • Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation as determined by a multidisciplinary tumor board and/or by radiation oncologist, surgeon, and medical oncologist or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
  • Provides an archival tumor tissue sample (≤5 years) or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, PD-L1 status, and biomarker research
  • If have had adverse events (AEs) due to previous anticancer therapies, must have recovered to < Grade 1 or baseline
  • If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)
  • If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
  • If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable

Exclusion Criteria:

  • Has diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present, the participant is ineligible
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
  • Has known history of, or active, neurologic paraneoplastic syndrome
  • Has an active infection requiring systemic therapy, with exceptions
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Has one or more of the following ophthalmological findings/conditions: intraocular pressure >21 mmHg and/or any diagnosis of glaucoma, diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion, diagnosis of retinal degenerative disease
  • Has received prior systemic anticancer therapy for their locally advanced or metastatic NSCLC
  • Has received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention
  • Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not required corticosteroids, and not have had radiation pneumonitis
  • Has known active central nervous system metastases and/or carcinomatous meningitis
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has active autoimmune disease that has required systemic treatment in the past 2 years
  • Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Is HIV-infected and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has history of allogenic tissue/solid organ transplant
  • Has not fully recovered from any effects of major surgical procedure

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Placebo with Pembrolizumab
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and placebo by oral tablets once daily until discontinuation criterion is met.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA ®
Other: Placebo
Oral tablets
Experimental: Calderasib with Pembrolizumab
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and calderasib by oral tablets until discontinuation criterion is met.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA ®
Drug: Calderasib
Oral tablets
Other Names:
  • MK-1084

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to approximately 42 months
PFS is defined as the time from randomization until either documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. PFS as determined by blinded independent central review (BICR) will be presented.
Up to approximately 42 months
Overall Survival (OS)
Time Frame: Up to approximately 56 months
OS is defined as the time from randomization to death due to any cause.
Up to approximately 56 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to approximately 42 months
ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
Up to approximately 42 months
Duration of Response (DOR)
Time Frame: Up to approximately 42 months
For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Up to approximately 42 months
Number of Participants Who Experience One or More Adverse Event (AEs)
Time Frame: Up to approximately 56 months
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experience an AE will be presented.
Up to approximately 56 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Time Frame: Up to approximately 56 months
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinue study treatment due to an AE will be presented.
Up to approximately 56 months
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
Time Frame: Baseline and Up to approximately 24 months
The EORTC QLQ-C30 is a 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?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. Higher scores indicate a better overall health status.
Baseline and Up to approximately 24 months
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score
Time Frame: Baseline and Up to approximately 24 months
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. Higher scores indicate a better level of functioning.
Baseline and Up to approximately 24 months
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score
Time Frame: Baseline and Up to approximately 24 months
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. Higher scores indicate a better level of functioning.
Baseline and Up to approximately 24 months
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score
Time Frame: Baseline and Up to approximately 24 months
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. A higher score indicates a worse level of dyspnea.
Baseline and Up to approximately 24 months
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score
Time Frame: Baseline and Up to approximately 24 months
The EORTC QLQ-C13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C13 Item 31 will be presented. A higher score indicates more frequent coughing.
Baseline and Up to approximately 24 months
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) Chest pain (Item 40) Score
Time Frame: Baseline and Up to approximately 24 months
The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C13 Item 40 will be presented. A higher score indicates a worse level of chest pain.
Baseline and Up to approximately 24 months
Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
Time Frame: Baseline and Up to approximately 24 months
TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in global health status (GHS) and quality of life (QoL) (EORTC QLQ-C30 Items 29 and 30) score. 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?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in GHS and QoL, will be presented. A longer TTD indicates a better outcome.
Baseline and Up to approximately 24 months
Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score
Time Frame: Baseline and Up to approximately 24 months
TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in physical functioning (EORTC QLQ-C30 Items 1-5) score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome.
Baseline and Up to approximately 24 months
Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score
Time Frame: Baseline and Up to approximately 24 months
TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in role functioning (EORTC QLQ-C30 Items 6 and 7) score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in role functioning score, will be presented. A longer TTD indicates a better outcome.
Baseline and Up to approximately 24 months
Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score
Time Frame: Baseline and Up to approximately 24 months
TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in dyspnea (EORTC QLQ-C30 Item 8) score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in dyspnea score, will be presented. A longer TTD indicates a better outcome.
Baseline and Up to approximately 24 months
Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score
Time Frame: Baseline and Up to approximately 24 months
TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in cough (EORTC QLQ-C13 Item 31) score. The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in cough score, will be presented. A longer TTD indicates a better outcome.
Baseline and Up to approximately 24 months
Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Chest pain (Item 40) Score
Time Frame: Baseline and Up to approximately 24 months
TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in chest pain (EORTC QLQ-C13 Item 40) score. The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline chest pain score, will be presented. A longer TTD indicates a better outcome.
Baseline and Up to approximately 24 months

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

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)

May 24, 2024

Primary Completion (Estimated)

February 19, 2029

Study Completion (Estimated)

February 18, 2031

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1084-004
  • MK-1084-004 (Other Identifier: MSD)
  • U1111-1296-8093 (Registry Identifier: UTN)
  • jRCT2031240213 (Registry Identifier: jRCT)
  • PHRR241128-007796 (Registry Identifier: PHRR)
  • 2023-507776-42-00 (Registry Identifier: EU CT)
  • KANDLELIT-004 (Other Identifier: MSD)

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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