AzTrials
AzTrials

Non-small Cell Lung CancerPhase 3NCT07554339

A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)

A Phase 3 study testing Calderasib and Durvalumab in people with Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 98 sites in 18 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

Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radiation therapy. 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 Durvalumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
310 participants
Where
98 sitesin 18 countries
Study dates
18 Jun 2026to 17 Aug 2037
Phase
Phase 3

Key requirements

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

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

Who may be able to join

  • The main inclusion criteria include but are not limited to the following:
  • Has a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology.
  • Has completed definitive platinum-based concurrent chemoradiotherapy (CCRT) prior to enrollment, without disease progression.
  • Has provided a tumor tissue sample for central laboratory testing of Kirsten rat sarcoma G12C (KRAS G12C) status, programmed cell death ligand 1 (PD-L1) status, and biomarker research.
  • Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result.
  • If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART).
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  • If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy.
  • If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.
  • Has a body weight ≥35 kg.

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Has a diagnosis of small cell lung cancer or mixed tumors with small cell elements.
  • Has a gastrointestinal disorder affecting absorption or is unable to swallow orally administered medication.
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease.
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
  • Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
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  • Has received prior treatment (other than definitive CCRT) for NSCLC.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years.
  • Has a history of, or has current, (noninfectious) pneumonitis/interstitial lung disease that required/requires steroids.
  • Has an active infection requiring systemic therapy.
  • Has a history of stem cell/solid organ transplant.
  • Has not adequately recovered from major surgery or has ongoing surgical complications.

Trial locations and contacts

98 sites in 18 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

98 sites in 18 countries

China22 sites, 22 recruiting

  • Beijing Peking Union Medical College Hospital ( Site 2220)

    Beijing, Beijing Municipality, 100730

    Study Coordinator, +8601069151188

    Recruiting

  • The Second Xiangya Hospital Of Central South University ( Site 2207)

    Changsha, Hunan, 410011

    Study Coordinator, 0731-85295888

    Recruiting

  • Hunan Cancer Hospital ( Site 2214)

    Changsha, Hunan, 410013

    Study Coordinator, 0731-89761269

    Recruiting

  • Sichuan Cancer hospital. ( Site 2218)

    Chengdu, Sichuan, 610213

    Study Coordinator, +8618227667677

    Recruiting

  • Chongqing University Cancer Hospital ( Site 2236)

    Chongqing, Sichuan, 400030

    Study Coordinator, 023-65456552

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University ( Site 2211)

    Guangzhou, Guangdong, 510145

    Study Coordinator, 02083062338

    Recruiting

  • The Second Affiliated Hospital of Guilin Medical University ( Site 2212)

    Guilin, Guangxi, 541199

    Study Coordinator, 07735590035

    Recruiting

  • Anhui Provincial Cancer Hospital ( Site 2209)

    Hefei, Anhui, 230031

    Study Coordinator, +8655165327666

    Recruiting

  • Shandong Cancer Hospital ( Site 2200)

    Jinan, Shandong, 250117

    Study Coordinator, +8613793150996

    Recruiting

  • Taizhou Hospital of Zhejiang Province ( Site 2223)

    Linhai, Zhejiang, 317000

    Study Coordinator, 057685199810

    Recruiting

  • Nanjing Drum Tower Hospital ( Site 2224)

    Nanjing, Jiangsu, 210000

    Study Coordinator, (86)025-83105910

    Recruiting

  • Guangxi Medical University Cancer Hospital ( Site 2202)

    Nanning, Guangxi, 530022

    Study Coordinator, +867715310045

    Recruiting

  • Zhongshan Hospital affiliated to Fudan University ( Site 2215)

    Shanghai, Shanghai Municipality, 200030

    Study Coordinator, +86 13621830381

    Recruiting

  • Fudan University Shanghai Cancer Center ( Site 2216)

    Shanghai, Shanghai Municipality, 200032

    Study Coordinator, 8602138196379

    Recruiting

  • Fourth Hospital of Hebei Medical University ( Site 2201)

    Shijiazhuang, Hebei, 050011

    Study Coordinator, +8631166696241

    Recruiting

  • Shanxi Provincial Cancer Hospital ( Site 2227)

    Taiyuan, Shanxi, 030013

    Study Coordinator, +863514881611

    Recruiting

  • Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2225)

    Ürümqi, Xinjiang, 830000

    Study Coordinator, +8609917968111

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University ( Site 2235)

    Wenzhou, Zhejiang, 325000

    Study Coordinator, 0577-55578100

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2206)

    Wuhan, Hubei, 430048

    Study Coordinator, +862783261400

    Recruiting

  • Hubei Cancer Hospital ( Site 2203)

    Wuhan, Hubei, 430070

    Study Coordinator, +862787670275

    Recruiting

  • Zhongshan Hospital Affiliated to Xiamen University ( Site 2213)

    Xiamen, Fujian, 361000

    Study Coordinator, +8613906036392

    Recruiting

  • The First Affiliated Hospital of Xiamen University. ( Site 2239)

    Xiamen, Fujian, 361003

    Study Coordinator, +8613860458889

    Recruiting

Other trials in China

Ukraine14 sites, 14 recruiting

  • Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 2002)

    Chernivtsi, Chernivetska Oblast, 58013

    Study Coordinator, +380505144910

    Recruiting

  • Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 2006)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

    Study Coordinator, +380342540325

    Recruiting

  • Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 2013)

    Kropyvnytskyi, Kirovohrad Oblast, 25006

    Study Coordinator, +380969680396

    Recruiting

  • Ukrainian Center of Tomotherapy ( Site 2014)

    Kropyvnytskyi, Kirovohrad Oblast, 25011

    Study Coordinator, +380676239652

    Recruiting

  • Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2012)

    Kryvyi Rih, Dnipropetrovsk Oblast, 50000

    Study Coordinator, +380973567855

    Recruiting

  • Kyiv City Clinical Oncology Center ( Site 2015)

    Kyiv, Kyivska Oblast, 03115

    Study Coordinator, +380672455533

    Recruiting

  • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 2005)

    Kyiv, 03057

    Study Coordinator, +380669472333

    Recruiting

  • Shalimov Institute of Surgery and Transplantation ( Site 2003)

    Kyiv, 03680

    Study Coordinator, +380933333911

    Recruiting

  • Volyn Regional Clinical Hospital ( Site 2010)

    Lutsk, Volyn Oblast, 43018

    Study Coordinator, +380503782998

    Recruiting

  • Lviv Oncology Regional Treatment and Diagnostic Center ( Site 2009)

    Lviv, Lviv Oblast, 79031

    Study Coordinator, +380975814015

    Recruiting

  • Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2000)

    Lviv, Lviv Oblast, 79059

    Study Coordinator, +380977453295

    Recruiting

  • Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2011)

    Odesa, Odesa Oblast, 65025

    Study Coordinator, +380972147211

    Recruiting

  • ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2001)

    Rivne, Rivne Oblast, 33010

    Study Coordinator, +380971921000

    Recruiting

  • Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 2004)

    Vinnytsia, Vinnytsia Oblast, 21029

    Study Coordinator, +380432511160

    Recruiting

Other trials in Ukraine

Turkey (Türkiye)9 sites, 9 recruiting

  • Adana Medical Park Seyhan Hastanesi ( Site 1910)

    Adana, 01140

    Study Coordinator, 00904444484

    Recruiting

  • Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1903)

    Adana, 01250

    Study Coordinator, 905353067506

    Recruiting

  • Hacettepe Universite Hastaneleri ( Site 1900)

    Ankara, 06230

    Study Coordinator, +903123052841

    Recruiting

  • Liv Hospital Ankara ( Site 1911)

    Ankara, 06680

    Study Coordinator, +90 5520045315

    Recruiting

  • Ankara Bilkent Şehir Hastanesi. ( Site 1906)

    Çankaya, Ankara, 6800

    Study Coordinator, 903125526000

    Recruiting

  • KARTAL DR. LÜTF KIRDAR ETM VE ARATIRMA HASTANES. ( Site 1909)

    Kartal, Istanbul, 34890

    Study Coordinator, +902164413900

    Recruiting

  • Erciyes University ( Site 1904)

    Kayseri, 38039

    Study Coordinator, +90 207 666 6270

    Recruiting

  • Mersin Sehir Eğitim ve Araştırma Hastanesi. ( Site 1907)

    Mersin, 33240

    Study Coordinator, 903242251000

    Recruiting

  • Recep Tayyip Erdogan University Training and Research Hospital ( Site 1908)

    Rize, 53020

    Study Coordinator, +905069939926

    Recruiting

Other trials in Turkey (Türkiye)

Spain7 sites, 7 recruiting

  • Hospital Universitari Vall d'Hebron ( Site 1800)

    Barcelona, 08035

    Study Coordinator, +34932746000

    Recruiting

  • Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 1807)

    Girona, Gerona, 17007

    Study Coordinator, +34972225834

    Recruiting

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1803)

    Madrid, 28007

    Study Coordinator, +34915868115

    Recruiting

  • Hospital Clinico San Carlos ( Site 1810)

    Madrid, 28040

    Study Coordinator, +34913303000x484835

    Recruiting

  • Hospital Universitario La Paz ( Site 1808)

    Madrid, 28046

    Study Coordinator, +34917277516

    Recruiting

  • Hospital Universitario Virgen Macarena ( Site 1805)

    Seville, 41007

    Study Coordinator, +34955008000

    Recruiting

  • Fundación Instituto Valenciano de Oncología ( Site 1809)

    Valencia, Valenciana, Comunitat, 46009

    Study Coordinator, +34961114230

    Recruiting

Other trials in Spain

Argentina6 sites, 6 recruiting

  • Hospital Britanico de Buenos Aires ( Site 0305)

    Buenos Aires, Buenos Aires F.D., C1280AEB

    Study Coordinator, +541127698713

    Recruiting

  • Hospital Italiano de Buenos Aires. ( Site 0300)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB

    Study Coordinator, +541149590200

    Recruiting

  • Clinica Adventista Belgrano ( Site 0304)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1430EGF

    Study Coordinator, +541132682903

    Recruiting

  • Instituto Alexander Fleming ( Site 0301)

    Ciudad Autonoma de Buenos Aires., Buenos Aires, C1426ANZ

    Study Coordinator, +541132218900

    Recruiting

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303)

    Mar del Plata, Buenos Aires, B7600FZO

    Study Coordinator, +542234963223

    Recruiting

  • Sanatorio Parque ( Site 0302)

    Rosario, Santa Fe Province, S2000DSV

    Study Coordinator, 54 341 40200222

    Recruiting

Other trials in Argentina

South Korea6 sites, 6 recruiting

  • Chungbuk National University Hospital ( Site 2502)

    Cheongju-si, North Chungcheong, 28644

    Study Coordinator, +82432696015

    Recruiting

  • Keimyung University Dongsan Hospital ( Site 2503)

    Daegu, Taegu-Kwangyokshi, 42601

    Study Coordinator, +82532586671

    Recruiting

  • National Cancer Center ( Site 2505)

    Goyang-si, Kyonggi-do, 10408

    Study Coordinator, +82319201694

    Recruiting

  • Severance Hospital, Yonsei University Health System ( Site 2501)

    Seoul, 03722

    Study Coordinator, 82-2-2228-0831

    Recruiting

  • Asan Medical Center ( Site 2500)

    Seoul, 05505

    Study Coordinator, +82230103214

    Recruiting

  • Ajou University Hospital ( Site 2504)

    Suwon, Kyonggi-do, 16499

    Study Coordinator, +8216886114

    Recruiting

Other trials in South Korea

United States5 sites, 5 recruiting

  • New York Oncology Hematology P.C ( Site 9000)

    Albany, New York, 12206

    Study Coordinator, 518-489-0044

    Recruiting

  • Virginia Cancer Specialists ( Site 0114)

    Fairfax, Virginia, 22031

    Study Coordinator, 703-208-3110

    Recruiting

  • NHO Revive Research Institute LLC ( Site 0118)

    Lincoln, Nebraska, 68506

    Study Coordinator, 402-484-4900

    Recruiting

  • Duly Healthcare ( Site 0158)

    Lisle, Illinois, 60532

    Study Coordinator, 630-545-7760

    Recruiting

  • WakeMed Raleigh Campus ( Site 0144)

    Raleigh, North Carolina, 27610

    Study Coordinator, 919-350-2873

    Recruiting

Other trials in United States

Taiwan5 sites, 5 recruiting

  • Taipei Medical University Shuang Ho Hospital ( Site 2612)

    New Taipei City, 23561

    Study Coordinator, +886-970-747-515

    Recruiting

  • National Cheng Kung University Hospital ( Site 2601)

    Tainan, 704

    Study Coordinator, +886-6-2353535#3120

    Recruiting

  • Mackay Memorial Hospital ( Site 2611)

    Taipei, 10449

    Study Coordinator, +886-2543-3535

    Recruiting

  • National Taiwan University Cancer Center (NTUCC) ( Site 2610)

    Taipei, 106

    Study Coordinator, +886-2-2312-3456

    Recruiting

  • Tri-Service General Hospital ( Site 2608)

    Taipei, 114

    Study Coordinator, +886287923311

    Recruiting

Other trials in Taiwan

Greece4 sites, 4 recruiting

  • University General Hospital of Alexandroupoli ( Site 1206)

    Alexandroupoli, East Macedonia and Thrace, 681 00

    Study Coordinator, +306973489404

    Recruiting

  • ALEXANDRA General Hospital of Athens ( Site 1200)

    Athens, Attica, 115 28

    Study Coordinator, +306934137080

    Recruiting

  • Athens Medical Center ( Site 1201)

    Athens, Attica, 151 25

    Study Coordinator, +306986817837

    Recruiting

  • Metaxa Cancer Hospital of Piraeus ( Site 1203)

    Piraeus, Attica, 185 37

    Study Coordinator, +306940583449

    Recruiting

Other trials in Greece

Italy4 sites, 4 recruiting

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1403)

    Meldola, Emilia-Romagna, 47014

    Study Coordinator, +390543739100

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1400)

    Milan, Lombardy, 20133

    Study Coordinator, +390223903831

    Recruiting

  • Istituto Nazionale Tumori Regina Elena ( Site 1404)

    Rome, Lazio, 00144

    Study Coordinator, +3906544289247

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1401)

    Rome, Lazio, 00168

    Study Coordinator, +390630155202

    Recruiting

Other trials in Italy

Australia3 sites, 3 recruiting

  • Frankston Hospital ( Site 2403)

    Frankston, Victoria, 3199

    Study Coordinator, +61 3 9784 7777

    Recruiting

  • Northern Beaches Hospital ( Site 2401)

    Frenchs Forest, New South Wales, 2086

    Study Coordinator, +61291055090

    Recruiting

  • Princess Alexandra Hospital ( Site 2406)

    Woolloongabba, Queensland, 4102

    Study Coordinator, +61731766577

    Recruiting

Other trials in Australia

Brazil3 sites, 3 recruiting

  • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0401)

    Barretos, São Paulo, 14784-400

    Study Coordinator, +551733216638

    Recruiting

  • CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0406)

    Fortaleza, Ceará, 60336-232

    Study Coordinator, +55 85 32865934

    Recruiting

  • AFECC ASSOCIACAO FEMININA EDUCACAO COMBATE CANCER ( Site 0416)

    Vitória, Espírito Santo, 29043-260

    Study Coordinator, +5527998469004

    Recruiting

Other trials in Brazil

Netherlands3 sites, 3 recruiting

  • University Medical Center Groningen ( Site 1505)

    Groningen, 9713 GZ

    Study Coordinator, +31503614679

    Recruiting

  • Leids Universitair Medisch Centrum ( Site 1503)

    Leiden, South Holland, 2333 ZA

    Study Coordinator, +31715566376

    Recruiting

  • Radboudumc ( Site 1504)

    Nijmegen, Gelderland, 6525 GA

    Study Coordinator, + 31243610353

    Recruiting

Other trials in Netherlands

Germany2 sites, 2 recruiting

  • Katholisches Marienkrankenhaus gGmbH ( Site 1101)

    Hamburg, 22087

    Study Coordinator, +494025460

    Recruiting

  • Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1108)

    Münster, North Rhine-Westphalia, 48153

    Study Coordinator, +492519764537

    Recruiting

Other trials in Germany

Japan2 sites, 2 recruiting

  • Kobe Minimally Invasive Cancer Center ( Site 2306)

    Kobe, Hyōgo, 650-0046

    Study Coordinator, +81-78-304-4100

    Recruiting

  • Sendai Kousei Hospital ( Site 2300)

    Sendai, Miyagi, 981-0914

    Study Coordinator, +81-22-728-8000

    Recruiting

Other trials in Japan

France1 site, 1 recruiting

  • Clinique Teissier Groupe ( Site 1006)

    Valenciennes, Nord, 59300

    Study Coordinator, +33327142434

    Recruiting

Other trials in France

Poland1 site, 1 recruiting

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1602)

    Przemyśl, Podkarpackie Voivodeship, 37-700

    Study Coordinator, +48166775000

    Recruiting

Other trials in Poland

United Kingdom1 site, 1 recruiting

  • St James's University Hospital ( Site 2100)

    Leeds, LS9 7TF

    Study Coordinator, +441132068436

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)

Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radiation therapy.

The goal of this trial is to learn if participants who receive calderasib and durvalumab live longer without the cancer growing or spreading compared to participants who receive placebo and durvalumab.

Being tested
Calderasib, Durvalumab, Placebo to MK-1084
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • CalderasibDrug

    Also called MK-1084

    Tablet for oral administration.

  • DurvalumabBiological

    Also called IMFINZI®

    Solution for intravenous (IV) infusion.

  • Placebo to MK-1084Other

    Placebo to MK-1084.

Study groups in NCT07554339
Study groupRoleWhat they receive
Calderasib + DurvalumabExperimentalParticipants will receive calderasib and durvalumab.
Receives: Drug: Calderasib; Biological: Durvalumab
Placebo + DurvalumabActive comparatorParticipants will receive placebo to calderasib and durvalumab.
Receives: Biological: Durvalumab; Other: Placebo to MK-1084

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 to the first documented disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 6 years

Secondary outcomes (9)

  1. Overall Survival (OS)

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

    Measured: Up to approximately 9 years

  2. Number of Participants Who Experience an Adverse Events (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 9 years

  3. Number of Participants Who Discontinue Study Treatment Due to an 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 9 years

  4. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.

    Measured: Up to approximately 9 years

  5. 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 9 years

  6. Distant Metastasis-Free Survival (DMFS)

    DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis as assessed by investigator, or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread beyond the original (primary) tumor/regional metastases to distant organs or distant lymph nodes.

    Measured: Up to approximately 9 years

  7. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Combined Score

    EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("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). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in GHS and QoL combined score will be presented.

    Measured: Baseline and up to approximately 9 years

  8. Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score will be presented.

    Measured: Baseline and up to approximately 9 years

  9. Change from Baseline in Role Functioning (EORTC QLQ-C30 Items 6 & 7) Combined Score

    The EORTC QLQ-C30 is a cancer specific health-related quality of life questionnaire. The role functioning score is based on participant responses to questions scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score was computed by averaging the raw scores of Items 6 and 7 and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. Higher scores indicate better role functioning. The change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) combined score will be reported.

    Measured: Baseline and up to approximately 9 years

Timeline

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

  1. First posted28 Apr 2026
  2. Study start18 Jun 2026
  3. Primary completion15 Dec 2032 (estimated)
  4. Study completion17 Aug 2037 (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
310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07554339
Sponsor's protocol ID
1084-015
Other IDs
2025-522038-29-00, U1111-1321-6971, MK-1084-015, KANDLELIT-015, jRCT2021260021, 2025
Status last verified
Oct 2026
First submitted
21 Apr 2026
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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