AzTrials
AzTrials

Non-small Cell Lung CancerPhase 3NCT06345729

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)

A Phase 3 study testing Calderasib and Pembrolizumab in people with Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 244 sites in 30 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

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Calderasib and Pembrolizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
348 participants
Where
244 sitesin 30 countries
Study dates
24 May 2024to 18 Feb 2031
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

  • 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 sample (≤5 years) or newly obtained core, incisional, or excisional biopsy or fine needle aspirate (FNA) of a tumor lesion, not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, programmed cell death ligand 1 (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

Who cannot join

  • 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 received prior systemic anticancer therapy for their locally advanced or metastatic NSCLC
Show all 15Show fewer
  • Has received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention
  • Has received radiotherapy to non-central nervous system (CNS) disease 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 CNS 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

Trial locations and contacts

244 sites in 30 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 30 countries

China45 sites

  • Beijing Cancer hospital ( Site 3133)

    Beijing, Beijing Municipality, 100142

    Active, not recruiting

  • Beijing Cancer hospital ( Site 3134)

    Beijing, Beijing Municipality, 100142

    Active, not recruiting

  • Beijing Peking Union Medical College Hospital-pneumology department ( Site 3102)

    Beijing, Beijing Municipality, 100730

    Active, not recruiting

  • Beijing Chest Hospital,Capital Medical University ( Site 3104)

    Beijing, Beijing Municipality, 101149

    Active, not recruiting

  • Jilin Province Tumor Hospital ( Site 3107)

    Changchun, Jilin, 130012

    Active, not recruiting

  • The Second Xiangya Hospital of Central South University ( Site 3130)

    Changsha, Hunan, 410011

    Completed

  • Hunan Cancer Hospital ( Site 3141)

    Changsha, Hunan, 410013

    Active, not recruiting

  • West China Hospital, Sichuan University ( Site 3140)

    Chengdu, Sichuan, 610000

    Active, not recruiting

  • The Third People's Hospital of Chengdu (CDTPH) ( Site 3157)

    Chengdu, Sichuan, 610031

    Active, not recruiting

  • Sichuan Cancer hospital. ( Site 3109)

    Chengdu, Sichuan, 610042

    Active, not recruiting

  • Chongqing University Cancer Hospital ( Site 3119)

    Chongqing, Chongqing Municipality, 400030

    Active, not recruiting

  • Army Medical Center of People's Liberation Army ( Site 3142)

    Chongqing, Chongqing Municipality, 400042

    Completed

  • Fujian Cancer Hospital ( Site 3127)

    Fuzhou, Fujian, 350014

    Active, not recruiting

  • The First Affiliated Hospital of Guangzhou Medical University ( Site 3108)

    Guangzhou, Guangdong, 510160

    Completed

  • Southern Medical University Nanfang Hospital ( Site 3128)

    Guangzhou, Guangdong, 510515

    Active, not recruiting

  • Sun Yat-sen University Cancer Center ( Site 3137)

    Guangzhou, Guangdong, 510555

    Completed

  • The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3115)

    Hangzhou, Zhejiang, 310006

    Active, not recruiting

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 3121)

    Hangzhou, Zhejiang, 310016

    Active, not recruiting

  • Harbin Medical University Cancer Hospital ( Site 3123)

    Harbin, Heilongjiang, 150081

    Active, not recruiting

  • Anhui Provincial Cancer Hospital ( Site 3136)

    Hefei, Anhui, 230031

    Active, not recruiting

  • JIAMUSI TUBERCULOSIS HOSPITAL(CANCER HOSPITAL) ( Site 3124)

    Jiamusi, Heilongjiang, 154007

    Active, not recruiting

  • Shandong Cancer Hospital ( Site 3116)

    Jinan, Shandong, 250117

    Active, not recruiting

  • Yunnan Province Cancer Hospital ( Site 3153)

    Kunming, Yunnan, 650107

    Active, not recruiting

  • Taizhou Hospital of Zhejiang Province ( Site 3145)

    Linhai, Zhejiang, 317000

    Active, not recruiting

  • LinYi Cancer Hospital ( Site 3111)

    Linyi, Shandong, 276001

    Active, not recruiting

  • The Second Affiliated Hospital of Nanchang University ( Site 3139)

    Nanchang, Jiangxi, 330000

    Completed

  • The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 3138)

    Nanchang, Jiangxi, 330209

    Active, not recruiting

  • Nanjing Gulou Hospital ( Site 3122)

    Nanjing, Jiangsu, 210008

    Active, not recruiting

  • Nanjing First Hospital ( Site 3154)

    Nanjing, Jiangsu, 210012

    Completed

  • The Second People's Hospital of Neijiang ( Site 3105)

    Neijiang, Sichuan, 641000

    Active, not recruiting

  • Shanghai Chest Hospital ( Site 3100)

    Shanghai, Shanghai Municipality, 200030

    Active, not recruiting

  • Fudan University Shanghai Cancer Center ( Site 3144)

    Shanghai, Shanghai Municipality, 200032

    Active, not recruiting

  • Zhongshan Hospital,Fudan University ( Site 3143)

    Shanghai, Shanghai Municipality, 200032

    Active, not recruiting

  • The First Affiliated Hospital of Soochow University ( Site 3146)

    Suzhou, Jiangsu, 215006

    Completed

  • Shanxi Cancer Hospital ( Site 3131)

    Taiyuan, Shanxi, 030000

    Active, not recruiting

  • Xinjiang Medical University Cancer Hospital - Urumqi ( Site 3101)

    Ürümqi, Xinjiang, 830000

    Completed

  • The First Affiliated Hospital of Wenzhou Medical University ( Site 3151)

    Wenzhou, Zhejiang, 325015

    Active, not recruiting

  • Tongji Hospital Tongji Medical,Science & Technology ( Site 3113)

    Wuhan, Hubei, 430000

    Active, not recruiting

  • Hubei Cancer Hospital ( Site 3126)

    Wuhan, Hubei, 430079

    Active, not recruiting

  • Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3155)

    Wuxi, Jiangsu, 214122

    Active, not recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 3150)

    Xi'an, Shaanxi, 710000

    Completed

  • The First Affiliated hospital of Xiamen University ( Site 3148)

    Xiamen, Fujian, 361003

    Active, not recruiting

  • The Second Affiliated Hospital of Air Force Medical University ( Site 3117)

    Xian, Shanxi, 710038

    Completed

  • The Second Affiliated Hospital of Air Force Medical University ( Site 3152)

    Xian, Shanxi, 710038

    Active, not recruiting

  • Henan Cancer Hospital ( Site 3149)

    Zhengzhou, Henan, 450008

    Active, not recruiting

Other trials in China

Japan25 sites, 25 recruiting

  • Nippon Medical School Hospital ( Site 3306)

    Bunkyo, Tokyo, 113-8603

    Study Coordinator, +81-3-3822-2131

    Recruiting

  • Chiba University Hospital ( Site 3322)

    Chiba, 260-8677

    Study Coordinator, +81-43-222-7171

    Recruiting

  • National Hospital Organization Kyushu Cancer Center ( Site 3316)

    Fukuoka, Fukuoka, 811-1395

    Study Coordinator, +81-92-541-3231

    Recruiting

  • Kansai Medical University Hospital ( Site 3312)

    Hirakata, Osaka, 573-1191

    Study Coordinator, +81-72-804-0101

    Recruiting

  • Hiroshima City Hiroshima Citizens Hospital ( Site 3314)

    Hiroshima, 730-8518

    Study Coordinator, +81-82-221-2291

    Recruiting

  • Kanazawa University Hospital ( Site 3308)

    Kanazawa, Ishikawa-ken, 920-8641

    Study Coordinator, +81-76-265-2000

    Recruiting

  • National Cancer Center Hospital East ( Site 3303)

    Kashiwa, Chiba, 277-8577

    Study Coordinator, +81-4-7133-1111

    Recruiting

  • St. Marianna University Hospital ( Site 3320)

    Kawasaki, Kanagawa, 216-8511

    Study Coordinator, +81-44-977-8111

    Recruiting

  • Saitama Prefectural Cancer Center ( Site 3304)

    Kitaadachi-gun, Saitama, 362-0806

    Study Coordinator, +81-48-722-1111

    Recruiting

  • Saiseikai Kumamoto Hospital ( Site 3318)

    Kumamoto, 861-4193

    Study Coordinator, +81-96-351-8000

    Recruiting

  • Kurume University Hospital ( Site 3317)

    Kurume, Fukuoka, 830-0011

    Study Coordinator, +81-942-35-3311

    Recruiting

  • Saiseikai Matsusaka Municipal Hospital ( Site 3311)

    Matsusaka, Mie-ken, 515-8544

    Study Coordinator, +81-598-23-1515

    Recruiting

  • National Hospital Organization Shikoku Cancer Center ( Site 3315)

    Matsuyam, Ehime, 719-0280

    Study Coordinator, +81-89-999-1111

    Recruiting

  • Nagoya University Hospital ( Site 3309)

    Nagoya, Aichi-ken, 466-8560

    Study Coordinator, +81-52-741-2111

    Recruiting

  • Miyagi Cancer Center ( Site 3301)

    Natori-shi, Miyagi, 981-1293

    Study Coordinator, +81-22-384-3151

    Recruiting

  • Niigata University Medical & Dental Hospital ( Site 3323)

    Niigata, 951-8520

    Study Coordinator, +81-25-223-6161

    Recruiting

  • Osaka Metropolitan University Hospital ( Site 3321)

    Osaka, 545-8586

    Study Coordinator, +81-6-6645-2121

    Recruiting

  • Gunma Prefectural Cancer Center ( Site 3302)

    Ōta, Gunma, 373-8550

    Study Coordinator, +81-276-38-0771

    Recruiting

  • Toho University Omori Medical Center ( Site 3319)

    Ōta-ku, Tokyo, 143-8541

    Study Coordinator, +81-3-3762-4151

    Recruiting

  • Sapporo Medical University Hospital ( Site 3324)

    Sapporo, Hokkaido, 060-8543

    Study Coordinator, +81-11-611-2111

    Recruiting

  • Sendai Kousei Hospital ( Site 3300)

    Sendai, Miyagi, 981-0914

    Study Coordinator, +81-22-222-6181

    Recruiting

  • Tokyo Medical University Hospital ( Site 3307)

    Shinjuku, Tokyo, 160-0023

    Study Coordinator, +81-3-3342-6111

    Recruiting

  • National Center for Global Health and Medicine ( Site 3305)

    Shinjuku, Tokyo, 162-8655

    Study Coordinator, +81-3-3202-7181

    Recruiting

  • Osaka Medical and Pharmaceutical University Hospital ( Site 3313)

    Takatsuki, Osaka, 569-8686

    Study Coordinator, +81-72-683-1221

    Recruiting

  • Fujita Health University Hospital ( Site 3310)

    Toyoake, Aichi-ken, 470-1192

    Study Coordinator, +81-562-93-2111

    Recruiting

Other trials in Japan

United States15 sites, 12 recruiting

  • New York Oncology Hematology, P.C. ( Site 0132)

    Albany, New York, 12206

    Study Coordinator, 518-489-3612

    Recruiting

  • CBCC Global Research, Inc. ( Site 0123)

    Bakersfield, California, 93309

    Study Coordinator, 661-322-2206

    Recruiting

  • Beverly Hills Cancer Center ( Site 0116)

    Beverly Hills, California, 90211

    Study Coordinator, 310-432-8955

    Recruiting

  • St. Vincent Frontier Cancer Center-Research ( Site 0105)

    Billings, Montana, 59102

    Study Coordinator, 402-238-6685

    Recruiting

  • University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103)

    Cincinnati, Ohio, 45219

    Study Coordinator, 513-556-6000

    Recruiting

  • Oncology Consultants P.A. ( Site 0113)

    Houston, Texas, 77030

    Study Coordinator, 713-600-0900

    Recruiting

  • Truman Medical Center ( Site 0126)

    Kansas City, Missouri, 64108

    Study Coordinator, 816-404-4093

    Recruiting

  • Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106)

    Kettering, Ohio, 45429

    Completed

  • Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0134)

    Lancaster, Pennsylvania, 17601

    Study Coordinator, 717-544-9400

    Recruiting

  • Circuit Clinical/SSM Health Dean Medical Group ( Site 0129)

    Madison, Wisconsin, 53715

    Study Coordinator, 608-410-2767

    Recruiting

  • Mount Sinai Cancer Center ( Site 0137)

    Miami Beach, Florida, 33140

    Completed

  • Atlantic Health System Morristown Medical Center ( Site 0121)

    Morristown, New Jersey, 07960

    Completed

  • Orchard Healthcare Research Inc. ( Site 0115)

    Skokie, Illinois, 60077

    Study Coordinator, 224-534-7580

    Recruiting

  • Cox Medical Center North ( Site 0133)

    Springfield, Missouri, 65807

    Study Coordinator, 417-875-3000

    Recruiting

  • Stamford Hospital ( Site 0136)

    Stamford, Connecticut, 06902

    Study Coordinator, 877-233-9355

    Recruiting

Other trials in United States

South Korea12 sites, 11 recruiting

  • The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 3606)

    Bupyeong-gu, Incheon, 21431

    Study Coordinator, +82-32-280-6474

    Recruiting

  • Yeungnam University Hospital ( Site 3607)

    Daegu, Taegu-Kwangyokshi, 42415

    Study Coordinator, +82536203848

    Recruiting

  • Keimyung University Dongsan Hospital ( Site 3611)

    Daegu, Taegu-Kwangyokshi, 42601

    Study Coordinator, +82532587737

    Recruiting

  • Chonnam National University Hwasun Hospital-Pulmonology ( Site 3604)

    Hwasun, Jeonranamdo, 58128

    Completed

  • Inha University Hospital ( Site 3610)

    Incheon, 22332

    Study Coordinator, +82328901038

    Recruiting

  • Chungnam national university hospital ( Site 3602)

    Junggu, Taejon-Kwangyokshi, 35015

    Study Coordinator, 82-42-257-5753

    Recruiting

  • Kyung Hee University Hospital ( Site 3605)

    Seoul, 02447

    Study Coordinator, 82-2-958-8511

    Recruiting

  • Korea University Anam Hospital ( Site 3609)

    Seoul, 02841

    Study Coordinator, +8229206409

    Recruiting

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3608)

    Seoul, 03312

    Study Coordinator, +82220304340

    Recruiting

  • Korea University Guro Hospital ( Site 3601)

    Seoul, 08308

    Study Coordinator, +82226261914

    Recruiting

  • The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3600)

    Suwon, Kyonggi-do, 16247

    Study Coordinator, 82-31-244-7983

    Recruiting

  • Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3603)

    Yangsan, Kyongsangnam-do, 50612

    Study Coordinator, +82-55-360-1415

    Recruiting

Other trials in South Korea

Ukraine12 sites, 10 recruiting

  • COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 2209)

    Cherkasy, Cherkasy Oblast, 18009

    Completed

  • Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 2210)

    Chernivtsi, Chernivetska Oblast, 58013

    Study Coordinator, +380955077568

    Recruiting

  • Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 2202)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

    Study Coordinator, +380978411455

    Recruiting

  • Medical Center "MedOffice Group" ( Site 2219)

    Kiev, Kyivska Oblast, 03022

    Study Coordinator, +380503858689

    Recruiting

  • Kirovohrad Regional Oncology Center-Chemotherapy department ( Site 2204)

    Kropyvnytskyi, Kirovohrad Oblast, 25011

    Study Coordinator, +380508412400

    Recruiting

  • Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2215)

    Kryvyi Rih, Dnipropetrovsk Oblast, 50000

    Study Coordinator, +380973567855

    Recruiting

  • LLC Clinic Verum Expert ( Site 2223)

    Kyiv, Kyivska Oblast, 03039

    Study Coordinator, +380443835959

    Recruiting

  • ME Volyn Regional Clinical Hospital of the Volyn Regional Council ( Site 2216)

    Lutsk, Volyn Oblast, 43018

    Study Coordinator, +380503782998

    Recruiting

  • Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2217)

    Lviv, Lviv Oblast, 79059

    Study Coordinator, +380506749772

    Recruiting

  • Rivne Regional Clinical Hospital ( Site 2205)

    Rivne, Rivne Oblast, 33007

    Completed

  • ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2920)

    Rivne, Rivne Oblast, 33010

    Study Coordinator, +380362633075

    Recruiting

  • Communal Noncommercial Enterprise "Podillia Regional Oncolog-Cardiothoracic department ( Site 2211)

    Vinnytsia, Vinnytsia Oblast, 21029

    Study Coordinator, +380953105783

    Recruiting

Other trials in Ukraine

Brazil10 sites, 9 recruiting

  • Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0437)

    Barretos, São Paulo, 14784-400

    Study Coordinator, +551733216638

    Recruiting

  • Hospital Mario Penna ( Site 0436)

    Belo Horizonte, Minas Gerais, 30380-472

    Study Coordinator, +553132999543

    Recruiting

  • Hospital de Caridade de Ijuí ( Site 0438)

    Ijuí, Rio Grande do Sul, 98700 000

    Study Coordinator, +5555991221138

    Recruiting

  • Liga Norte Riograndense Contra o Câncer ( Site 0439)

    Natal, Rio Grande do Norte, 59062-000

    Study Coordinator, +558440095595

    Recruiting

  • Hospital de Clínicas de Passo Fundo ( Site 0442)

    Passo Fundo, Rio Grande do Sul, 99010-260

    Study Coordinator, +5554981271411

    Recruiting

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro Multidisciplinar de Pesquisa Clínica ( Site 0435)

    Porto Alegre, Rio Grande do Sul, 90050-170

    Study Coordinator, +555132148143

    Recruiting

  • Hospital de Câncer de Recife ( Site 0447)

    Recife, Pernambuco, 50040-000

    Study Coordinator, +558132178084

    Recruiting

  • Instituto Nacional de Câncer - INCA ( Site 0446)

    Rio de Janeiro, 20230-130

    Study Coordinator, +552132076564

    Recruiting

  • Americas ( Site 0431)

    Rio de Janeiro, 22775-001

    Study Coordinator, +552133852088

    Recruiting

  • Oncoclínica Oncologistas Associados ( Site 0441)

    Teresina, Piauí, 64049-200

    Completed

Other trials in Brazil

Georgia10 sites, 8 recruiting

  • High Technology Hospital Medcenter ( Site 1203)

    Batumi, Adjara, 6000

    Study Coordinator, +995596226060

    Recruiting

  • JSC "Vian" ( Site 1211)

    Kutaisi, Imereti, 4600

    Study Coordinator, +995599705858

    Recruiting

  • Caucasus Medical Centre ( Site 1202)

    Tbilisi, Adjara, 0186

    Study Coordinator, +995 597 550 140

    Recruiting

  • American Hospital Network LLC ( Site 1208)

    Tbilisi, 0102

    Study Coordinator, +995 571 300 705

    Recruiting

  • Todua Clinic, LLC ( Site 1204)

    Tbilisi, 0112

    Study Coordinator, +995322575757

    Recruiting

  • TSMU and Ingorokva High Medical Technology University Clinic LTD ( Site 1201)

    Tbilisi, 0144

    Completed

  • "Institute of Clinical Oncology" LTD ( Site 1210)

    Tbilisi, 0159

    Study Coordinator, +995599406920

    Recruiting

  • New Hospitals ( Site 1200)

    Tbilisi, 0162

    Study Coordinator, +995 598 988 566

    Recruiting

  • Cancer Research Centre. Mardaleishvili Medical Centre ( Site 1205)

    Tbilisi, 0177

    Study Coordinator, +995322430100

    Recruiting

  • Tbilisi Institute of Medicine ( Site 1206)

    Tbilisi, 1206

    Completed

Other trials in Georgia

Italy10 sites, 10 recruiting

  • CRO-IRCCS-Clinical Oncology ( Site 1605)

    Aviano, Friuli Venezia Giulia, 33081

    Study Coordinator, +390434309464

    Recruiting

  • Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno-UOC Oncologia Medica Livorno ( Site 1608)

    Livorno, Tuscany, 57124

    Study Coordinator, 00390586223416

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1600)

    Milan, Lombardy, 20133

    Study Coordinator, +390223903829

    Recruiting

  • Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1604)

    Milan, Lombardy, 20141

    Study Coordinator, +390257489482

    Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia clinica sperimentale Toraco-Polmonare ( Site 1607)

    Naples, Campania, 80131

    Study Coordinator, +390811777029

    Recruiting

  • A.O.R.N. Ospedale dei Colli - Monaldi V.-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1602)

    Naples, Napoli, 80131

    Study Coordinator, 0817062652

    Recruiting

  • IOV - Istituto Oncologico Veneto IRCCS UOSD - Unità di ricerca clinica ( Site 1603)

    Padova, 35131

    Study Coordinator, +390498215649

    Recruiting

  • Ospedale Santa Maria delle Croci ( Site 1606)

    Ravenna, Emilia-Romagna, 48121

    Study Coordinator, +390544285247

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1601)

    Rome, Lazio, 00168

    Study Coordinator, 00390630156318

    Recruiting

  • Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1609)

    Rome, Roma, 00144

    Study Coordinator, +390652662205

    Recruiting

Other trials in Italy

Turkey (Türkiye)10 sites, 10 recruiting

  • Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2107)

    Adana, 01140

    Study Coordinator, +90 322 456 19 00

    Recruiting

  • SBU GULHANE EGITIM VE ARASTIRMA HASTANESI Onkoloji ( Site 2104)

    Ankara, 06010

    Study Coordinator, +905058726378

    Recruiting

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 2101)

    Ankara, 06230

    Study Coordinator, +90 312 305 10 80

    Recruiting

  • Memorial Ankara Hastanesi-Medical Oncology ( Site 2106)

    Ankara, 06520

    Study Coordinator, +903122536666

    Recruiting

  • Ankara Bilkent Şehir Hastanesi ( Site 2100)

    Ankara, 06800

    Study Coordinator, +903125526000

    Recruiting

  • Dokuz Eylul Universitesi Hastanesi ( Site 2108)

    Balçova, İzmir, 35340

    Study Coordinator, +902323434343

    Recruiting

  • Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2102)

    Bornova, İzmir, 35100

    Study Coordinator, +905322202675

    Recruiting

  • Medipol Mega Universite Hastanesi-oncology ( Site 2105)

    Istanbul, 34214

    Study Coordinator, +902124447044

    Recruiting

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2103)

    Istanbul, 34722

    Study Coordinator, +902166065200

    Recruiting

  • Sakarya Training and Research Hospital ( Site 2109)

    Sakarya, 54290

    Study Coordinator, +902648884000

    Recruiting

Other trials in Turkey (Türkiye)

Spain9 sites, 9 recruiting

  • Hospital Universitari Vall d Hebron ( Site 2010)

    Barcelona, 08035

    Study Coordinator, +34 932 543 450

    Recruiting

  • Hospital Insular de Gran Canaria-Oncology ( Site 2019)

    Las Palmas de Gran Canaria, Las Palmas, 35001

    Study Coordinator, +34 928441738

    Recruiting

  • Hospital Universitario Severo Ochoa ( Site 2024)

    Leganés, Madrid, Comunidad de, 28911

    Study Coordinator, +34914818000

    Recruiting

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2012)

    Madrid, Madrid, Comunidad de, 28009

    Study Coordinator, +34 915868115

    Recruiting

  • Hospital Universitario La Princesa ( Site 2020)

    Madrid, 28006

    Study Coordinator, +34915202200

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 2017)

    Madrid, 28040

    Study Coordinator, 34915504800x253900

    Recruiting

  • H.R.U Málaga - Hospital General-Oncology ( Site 2014)

    Málaga, Malaga, 29011

    Study Coordinator, +34 951308130

    Recruiting

  • Hospital Universitario Virgen de la Victoria ( Site 2021)

    Málaga, 29010

    Study Coordinator, 0034671594566

    Recruiting

  • Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2015)

    Seville, 41009

    Study Coordinator, 34954712941

    Recruiting

Other trials in Spain

Argentina7 sites, 6 recruiting

  • Centro de Oncología e Investigación de Buenos Aires ( Site 0308)

    Berazategui, Buenos Aires, B1884BBF

    Study Coordinator, +541142262013

    Recruiting

  • AUSTRAL MEDICAL CENTER ( Site 0302)

    CABA, Buenos Aires, C1019ABS

    Completed

  • Centro Oncologico Korben ( Site 0304)

    CABA, Buenos Aires, C1426AGE

    Study Coordinator, 1157507952

    Recruiting

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)

    Mar del Plata, Buenos Aires, B7600FZO

    Study Coordinator, 02234963224

    Recruiting

  • Fundacion Estudios Clinicos ( Site 0306)

    Rosario, Santa Fe Province, S2000DEJ

    Study Coordinator, +543412221472

    Recruiting

  • Sanatorio Parque ( Site 0301)

    Rosario, Santa Fe Province, S2000DSV

    Study Coordinator, +54341420-0222

    Recruiting

  • Clinica Viedma S. A ( Site 0307)

    Viedma, Río Negro Province, R8500ACE

    Study Coordinator, +54 2920 42-8700

    Recruiting

Other trials in Argentina

France7 sites, 7 recruiting

  • Centre Hospitalier d'Avignon-Service d'Oncologie médicale et d'hématologie clinique ( Site 1104)

    Avignon, Vaucluse, 84000

    Study Coordinator, +33432753333

    Recruiting

  • Hôpital Ambroise Paré-Department of Respiratory Diseases and Thoracic Oncology ( Site 1105)

    Boulogne-Billancourt, Île-de-France Region, 92100

    Study Coordinator, +33149095806

    Recruiting

  • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 1101)

    Clermont-Ferrand, Puy-de-Dome, 63003

    Study Coordinator, +33473278005

    Recruiting

  • Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1103)

    Dijon, Bourgogne-Franche-Comté, 21000

    Study Coordinator, +33380293772

    Recruiting

  • Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1108)

    Nice, Alpes-Maritimes, 06000

    Study Coordinator, +33492038281

    Recruiting

  • Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire ( Site 1106)

    Nîmes, Gard, 30029

    Study Coordinator, +33 4 66 68 32 21

    Recruiting

  • Clinique Teissier Groupe ( Site 1100)

    Valenciennes, Nord, 59304

    Study Coordinator, +33327142337

    Recruiting

Other trials in France

Greece7 sites, 7 recruiting

  • Agios Savvas Regional Cancer Hospital-2nd Medical Oncology Department ( Site 1407)

    Athens, Attica, 115 22

    Study Coordinator, +302106409501

    Recruiting

  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1400)

    Athens, Attica, 115 27

    Study Coordinator, +302107700220

    Recruiting

  • University General Hospital of Larissa-Oncology Clinic ( Site 1403)

    Larissa, Thessaly, 411 10

    Study Coordinator, +302413502124

    Recruiting

  • Athens Medical Center ( Site 1406)

    Marousi, Attica, 151 25

    Study Coordinator, +302107464642

    Recruiting

  • UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1402)

    Pátrai, Achaia, 26504

    Study Coordinator, +302610999791

    Recruiting

  • European Interbalkan Medical Center ( Site 1404)

    Thessaloniki, 570 01

    Study Coordinator, +302310380000

    Recruiting

  • G. Papanikolaou General Hospital-Pulmonary Clinic of Aristotle University of Thessaloniki ( Site 1405)

    Thessaloniki, 570 10

    Study Coordinator, 0030 231330787476

    Recruiting

Other trials in Greece

Romania7 sites, 7 recruiting

  • SC ONCO CARD SRL ( Site 1995)

    Brasov, 500052

    Study Coordinator, +40268 994

    Recruiting

  • Centrul de Diagnostic si Tratament Provita. ( Site 1992)

    Bucharest, Bucharest, 020335

    Study Coordinator, +4021.9432

    Recruiting

  • SC MNT HEALTHCARE EUROPE SRL ( Site 1991)

    Bucharest, 077190

    Study Coordinator, +40722927377

    Recruiting

  • Institutul Oncologic Cluj-Oncologie Medicala ( Site 1999)

    Cluj-Napoca, 400015

    Study Coordinator, +40264598362

    Recruiting

  • Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1994)

    Craiova, Dolj, 200542

    Study Coordinator, +40731604432

    Recruiting

  • Sigmedical Services SRL ( Site 1997)

    Suceava, 720214

    Study Coordinator, +4 0330 803 483

    Recruiting

  • Cabinet Medical Oncomed ( Site 1998)

    Timișoara, Timiș County, 300239

    Study Coordinator, +40356460995

    Recruiting

Other trials in Romania

Canada6 sites, 6 recruiting

  • QEII Health Sciences Centre - Victoria General Site-Dept. of Medical Oncology ( Site 0208)

    Halifax, Nova Scotia, B3H 2Y9

    Study Coordinator, 9024737964

    Recruiting

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0205)

    Hamilton, Ontario, L8V 5C2

    Study Coordinator, 9053879495

    Recruiting

  • St. Marys Hospital Center ( Site 0204)

    Montreal, Quebec, H3T 1M5

    Study Coordinator, 5143453511

    Recruiting

  • Sunnybrook Research Institute ( Site 0206)

    Toronto, Ontario, M4N 3M5

    Study Coordinator, 4164805000x687435

    Recruiting

  • Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0207)

    Trois-Rivières, Quebec, G8Z 3R9

    Study Coordinator, 8196973333x63238

    Recruiting

  • CancerCare Manitoba ( Site 0210)

    Winnipeg, Manitoba, R3E 0V9

    Study Coordinator, 204-787-4156

    Recruiting

Other trials in Canada

Poland6 sites, 4 recruiting

  • Szpital Specjalistyczny im. Henryka Klimontowicza ( Site 1801)

    Gorlice, Lesser Poland Voivodeship, 38-300

    Active, not recruiting

  • Pratia MCM Krakow ( Site 1808)

    Krakow, Lesser Poland Voivodeship, 30-727

    Completed

  • Uniwersytecki Szpital Kliniczny nr 4 w Lublinie ( Site 1805)

    Lublin, Lublin Voivodeship, 20-090

    Study Coordinator, +48 814485180

    Recruiting

  • Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie ( Site 1809)

    Olsztyn, Warmian-Masurian Voivodeship, 10-357

    Study Coordinator, +48895322978

    Recruiting

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1804)

    Przemyśl, Podkarpackie Voivodeship, 37-700

    Study Coordinator, +48166775000

    Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 1800)

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, +48225462336

    Recruiting

Other trials in Poland

Bulgaria5 sites, 5 recruiting

  • MBAL Uni Hospital-Department of Medical Oncology ( Site 1000)

    Panagyurishte, Pazardzhik, 4500

    Study Coordinator, +35935788581

    Recruiting

  • MHAT - Heart and Brain ( Site 1006)

    Pleven, 5804

    Study Coordinator, +35988030371

    Recruiting

  • Medical Center Futuremeds ( Site 1007)

    Plovdiv, 4000

    Study Coordinator, +359886744494

    Recruiting

  • Complex Oncology Center - Plovdiv EOOD ( Site 1003)

    Plovdiv, 4004

    Study Coordinator, +359 32 277 240

    Recruiting

  • Multiprofile Hospital for Active Treatment SerdikaМЕD EOOD-Second Department of Medical Oncology ( Site 1002)

    Sofia, Sofia (stolitsa), 1632

    Study Coordinator, +35929049100

    Recruiting

Other trials in Bulgaria

Chile5 sites, 5 recruiting

  • Orlandi Oncologia-Oncology ( Site 0503)

    Santiago, Region M. de Santiago, 7500713

    Study Coordinator, +56226057491

    Recruiting

  • FALP-UIDO ( Site 0501)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, +56224205098

    Recruiting

  • Centro de Oncología de Precisión ( Site 0502)

    Santiago, Region M. de Santiago, 7560913

    Study Coordinator, 56991612199

    Recruiting

  • Bradfordhill-Clinical Area ( Site 0504)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +56229490970

    Recruiting

  • Clinica Universidad Catolica del Maule-Oncology ( Site 0500)

    Talca, Maule Region, 3465584

    Study Coordinator, +56947532700

    Recruiting

Other trials in Chile

Netherlands5 sites, 5 recruiting

  • Ziekenhuis Gelderse Vallei ( Site 1705)

    Ede, Gelderland, 6716 RP

    Study Coordinator, 0318435499

    Recruiting

  • Ziekenhuis St. Jansdal-Poli Longziekten ( Site 1701)

    Harderwijk, Gelderland, 3844 DG

    Study Coordinator, 0031341463504

    Recruiting

  • Ziekenhuisgroep Twente, locatie Almelo ( Site 1706)

    Hengelo, Overijssel, 7555 DL

    Study Coordinator, +31887087878

    Recruiting

  • Universitair Medisch Centrum Utrecht ( Site 1704)

    Utrecht, 3584 CX

    Study Coordinator, 00318875555555

    Recruiting

  • Isala, locatie Zwolle-Poli Longziekten ( Site 1700)

    Zwolle, Overijssel, 8025 AB

    Study Coordinator, 0031886243254

    Recruiting

Other trials in Netherlands

Australia4 sites, 4 recruiting

  • Chris O'Brien Lifehouse ( Site 3000)

    Camperdown, New South Wales, 2050

    Study Coordinator, +61285140140

    Recruiting

  • Frankston Hospital ( Site 3002)

    Frankston, Victoria, 3199

    Study Coordinator, +61397847777

    Recruiting

  • One Clinical Research ( Site 3001)

    Nedlands, Western Australia, 6009

    Study Coordinator, +61862799466

    Recruiting

  • Cancer Care Service Hervey Bay ( Site 3003)

    Urraween, Queensland, 4655

    Study Coordinator, +610743256110

    Recruiting

Other trials in Australia

Colombia4 sites, 4 recruiting

  • Clinica Oncologica Colsubsidio ( Site 4003)

    Bogota, Cundinamarca, 110111

    Study Coordinator, +573142059194

    Recruiting

  • Hemato Oncologos SA ( Site 4002)

    Cali, Valle del Cauca Department, 76001

    Study Coordinator, +573167711932

    Recruiting

  • Oncologos del Occidente ( Site 4005)

    Pereira, Risaralda Department, 660001

    Study Coordinator, +57 3187715522

    Recruiting

  • Sociedad De Oncología y Hematología Del Cesar SAS ( Site 4000)

    Valledupar, Cesar Department, 200001

    Study Coordinator, +573122354788

    Recruiting

Other trials in Colombia

Germany4 sites, 4 recruiting

  • Evangelisches Krankenhaus Bielefeld - Johannesstift ( Site 1307)

    Bielefeld, North Rhine-Westphalia, 33611

    Study Coordinator, 0521 772 75504

    Recruiting

  • Universitätsmedizin Greifswald ( Site 1308)

    Greifswald, Mecklenburg-Vorpommern, 17489

    Study Coordinator, +4938348622006

    Recruiting

  • Krankenhaus Bethanien ( Site 1303)

    Solingen, North Rhine-Westphalia, 42699

    Study Coordinator, +49212636661

    Recruiting

  • Marienhospital Stuttgart ( Site 1302)

    Stuttgart, Baden-Wurttemberg, 70199

    Study Coordinator, +49711064893273

    Recruiting

Other trials in Germany

India4 sites, 3 recruiting

  • Sir H. N. Reliance Foundation Hospital and Research Centre ( Site 3201)

    Mumbai, Maharashtra, 400004

    Active, not recruiting

  • Tata Memorial Hospital ( Site 3205)

    Mumbai, Maharashtra, 400012

    Study Coordinator, 02224177000

    Recruiting

  • AIIMS New Delhi Dept of Medicine ( Site 3206)

    New Delhi, National Capital Territory of Delhi, 110029

    Study Coordinator, +91-9650629370

    Recruiting

  • Indraprastha Apollo Hospitals-APOLLO RESEARCH INNOVATION ( Site 3203)

    New Delhi, National Capital Territory of Delhi, 110076

    Study Coordinator, +919426166688

    Recruiting

Other trials in India

Mexico4 sites, 4 recruiting

  • Instituto Nacional de Cancerologia. ( Site 0608)

    México, 14080

    Study Coordinator, +525556280400

    Recruiting

  • Arké SMO S.A. de C.V. ( Site 0602)

    Mexico City, Mexico City, 06700

    Study Coordinator, 5533345856

    Recruiting

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 0600)

    Monterrey, Nuevo León, 66460

    Study Coordinator, +528180883663

    Recruiting

  • Oaxaca Site Management Organization S.C. ( Site 0603)

    Oaxaca City, 68000

    Study Coordinator, +529515147056

    Recruiting

Other trials in Mexico

Philippines4 sites, 3 recruiting

  • The Medical City ( Site 3507)

    Pasig, National Capital Region, 1600

    Study Coordinator, (02)6356789 loc 5083

    Recruiting

  • Lung Center of the Philippines-Pulmonary, Critical Care and Sleep Medicine ( Site 3503)

    Quezon City, National Capital Region, 1100

    Study Coordinator, +632 892 46101*1309

    Recruiting

  • Veterans Memorial Medical Center-Section of Oncology ( Site 3505)

    Quezon City, National Capital Region, 1100

    Active, not recruiting

  • ST. LUKE'S MEDICAL CENTER-Medical oncology ( Site 3501)

    Quezon City, National Capital Region, 1102

    Study Coordinator, +63287230101

    Recruiting

Other trials in Philippines

Austria2 sites, 2 recruiting

  • Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 2401)

    Graz, Styria, 8036

    Study Coordinator, 004331638512183

    Recruiting

  • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2400)

    Vienna, 1210

    Study Coordinator, 0043 1 27700 72212

    Recruiting

Other trials in Austria

United Kingdom2 sites, 2 recruiting

  • Royal Devon & Exeter Hospital-Oncology ( Site 2302)

    Exeter, Devon, EX2 5DW

    Study Coordinator, +44 (0) 1392 402869

    Recruiting

  • Milton Keynes Hospital ( Site 2304)

    Milton Keynes, Buckinghamshire, MK6 5LD

    Study Coordinator, 01908 997609

    Recruiting

Other trials in United Kingdom

Costa Rica1 site, 1 recruiting

  • Onco Tech, S.A. ( Site 4102)

    San José, 10103

    Study Coordinator, +50622586260

    Recruiting

Other trials in Costa Rica

New Zealand1 site, 1 recruiting

  • Auckland City Hospital ( Site 3400)

    Auckland, 1023

    Study Coordinator, +6493074949

    Recruiting

Other trials in New Zealand

Peru1 site, 1 recruiting

  • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 4301)

    Lima, 15036

    Study Coordinator, 511 2241598 anex 121

    Recruiting

Other trials in Peru

About this study

Official title: 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 is one primary study hypothesis:

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).

Read the detailed description

Per Protocol Amendment 04, overall survival (OS) was moved to be a secondary outcome measure. Additionally, no new participants will be offered Second Course treatment for pembrolizumab.

Being tested
Calderasib, Placebo, Pembrolizumab
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), Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C)
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.

  • CalderasibDrug

    Also called MK-1084

    Oral tablets

  • PlaceboOther

    Oral tablets

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA ®

    IV infusion

Study groups in NCT06345729
Study groupRoleWhat they receive
Calderasib with PembrolizumabExperimentalParticipants 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.
Receives: Drug: Calderasib; Biological: Pembrolizumab
Placebo with PembrolizumabActive comparatorParticipants 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.
Receives: Other: Placebo; Biological: Pembrolizumab

What is being measured

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

  1. Progression-Free Survival (PFS)

    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.

    Measured: Up to approximately 42 months

Secondary outcomes (17)

  1. Overall Survival

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

    Measured: Up to approximately 57 months

  2. Objective Response Rate (ORR)

    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.

    Measured: Up to approximately 42 months

  3. Duration of Response (DOR)

    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.

    Measured: Up to approximately 42 months

  4. Number of Participants Who Experience One or More Adverse Event (AEs)

    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.

    Measured: Up to approximately 80 months

  5. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)

    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.

    Measured: Up to approximately 80 months

  6. 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

    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.

    Measured: Baseline and Up to approximately 24 months

  7. Change From Baseline in EORTC QLQ-C30 Physical Functioning (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). 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.

    Measured: Baseline and Up to approximately 24 months

  8. Change From Baseline in EORTC QLQ-C30 Role Functioning (Items 6-7) 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). 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.

    Measured: Baseline and Up to approximately 24 months

  9. Change From Baseline in EORTC QLQ-C30 Dyspnea (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). 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.

    Measured: Baseline and Up to approximately 24 months

  10. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module (EORTC QLQ-LC13) Cough (Item 31) Score

    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.

    Measured: Baseline and Up to approximately 24 months

  11. Change From Baseline in EORTC QLQ-LC13 Chest Pain (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). 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.

    Measured: Baseline and Up to approximately 24 months

  12. Time to Deterioration (TTD) in EORTC-QLQ-C30 Global Health Status (Item 29) Quality of Life (Item 30) Combined Score

    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.

    Measured: Baseline and Up to approximately 24 months

  13. TTD in EORTC-QLQ-C30 Physical Functioning (Items 1-5) Score

    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.

    Measured: Baseline and Up to approximately 24 months

  14. TTD in EORTC-QLQ-C30 Role Functioning (Items 6-7) Score

    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.

    Measured: Baseline and Up to approximately 24 months

  15. TTD in EORTC-QLQ-C30 Dyspnea (Item 8) Score

    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.

    Measured: Baseline and Up to approximately 24 months

  16. TTD in EORTC QLQ-LC13 Cough (Item 31) Score

    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.

    Measured: Baseline and Up to approximately 24 months

  17. TTD in EORTC QLQ-LC13 Chest Pain (Item 40) Score

    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.

    Measured: Baseline and Up to approximately 24 months

Timeline

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

  1. First posted3 Apr 2024
  2. Study start24 May 2024
  3. Primary completion24 Jan 2028 (estimated)
  4. Study completion18 Feb 2031 (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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
348 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06345729
Sponsor's protocol ID
1084-004
Other IDs
MK-1084-004, U1111-1296-8093, 2023-507776-42-00, jRCT2031240213, PHRR241128-007796, KANDLELIT-004, 2023
Status last verified
Oct 2026
First submitted
28 Mar 2024
Last updated
20 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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