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

August 27, 2026 updated by: Merck Sharp & Dohme LLC

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

310

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
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1430EGF
        • Recruiting
        • Clinica Adventista Belgrano ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: +541132682903
      • Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: +541132218900
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Recruiting
        • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: +542234963223
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1280AEB
        • Recruiting
        • Hospital Britanico de Buenos Aires ( Site 0305)
        • Contact:
          • Study Coordinator
          • Phone Number: +541127698713
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DSV
        • Recruiting
        • Sanatorio Parque ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: 54 341 40200222
  • Australia
    • New South Wales
      • Frenchs Forest, New South Wales, Australia, 2086
        • Recruiting
        • Northern Beaches Hospital ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: +61291055090
  • Brazil
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29043-260
        • Recruiting
        • AFECC ASSOCIACAO FEMININA EDUCACAO COMBATE CANCER ( Site 0416)
        • Contact:
          • Study Coordinator
          • Phone Number: +5527998469004
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Recruiting
        • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0401)
        • Contact:
          • Study Coordinator
          • Phone Number: +551733216638
  • China
    • Anhui
      • Hefei, Anhui, China, 230031
        • Recruiting
        • Anhui Provincial Cancer Hospital ( Site 2209)
        • Contact:
          • Study Coordinator
          • Phone Number: +8655165327666
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Recruiting
        • Zhongshan Hospital Affiliated to Xiamen University ( Site 2213)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613906036392
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated Hospital of Xiamen University. ( Site 2239)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613860458889
    • Guangxi
      • Qingxiu District, Guangxi, China, 530022
        • Recruiting
        • Guangxi Medical University Affiliated Tumor Hospital ( Site 2202)
        • Contact:
          • Study Coordinator
          • Phone Number: +867715310045
    • Hubei
      • Wuhan, Hubei, China, 430048
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2206)
        • Contact:
          • Study Coordinator
          • Phone Number: +862783261400
      • Wuhan, Hubei, China, 430070
        • Recruiting
        • Hubei Cancer Hospital ( Site 2203)
        • Contact:
          • Study Coordinator
          • Phone Number: +862787670275
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital Of Central South University ( Site 2207)
        • Contact:
          • Study Coordinator
          • Phone Number: 0731-85295888
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Drum Tower Hospital ( Site 2224)
        • Contact:
          • Study Coordinator
          • Phone Number: (86)025-83105910
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital ( Site 2200)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613793150996
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Recruiting
        • Zhongshan Hospital affiliated to Fudan University ( Site 2215)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 13621830381
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Recruiting
        • Shanxi Provincial Cancer Hospital ( Site 2227)
        • Contact:
          • Study Coordinator
          • Phone Number: +863514881611
    • Sichuan
      • Chengdu, Sichuan, China, 610213
        • Recruiting
        • Sichuan Cancer hospital. ( Site 2218)
        • Contact:
          • Study Coordinator
          • Phone Number: +8618227667677
  • France
    • Nord
      • Valenciennes, Nord, France, 59300
        • Recruiting
        • Clinique Teissier Groupe ( Site 1006)
        • Contact:
          • Study Coordinator
          • Phone Number: +33327142434
  • Germany
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48153
        • Recruiting
        • Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1108)
        • Contact:
          • Study Coordinator
          • Phone Number: +492519764537
  • Greece
    • Attica
      • Athens, Attica, Greece, 151 25
        • Recruiting
        • Athens Medical Center ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: +306986817837
      • Athens, Attica, Greece, 115 28
        • Recruiting
        • ALEXANDRA General Hospital of Athens ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: +306934137080
      • Piraeus, Attica, Greece, 185 37
        • Recruiting
        • Metaxa Cancer Hospital of Piraeus ( Site 1203)
        • Contact:
          • Study Coordinator
          • Phone Number: +306940583449
    • East Macedonia and Thrace
      • Alexandroupoli, East Macedonia and Thrace, Greece, 681 00
        • Recruiting
        • University General Hospital of Alexandroupoli ( Site 1206)
        • Contact:
          • Study Coordinator
          • Phone Number: +306973489404
  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: +390630155202
  • Japan
    • Miyagi
      • Sendai, Miyagi, Japan, 981-0914
        • Recruiting
        • Sendai Kousei Hospital ( Site 2300)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-22-728-8000
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • University Medical Center Groningen ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: +31503614679
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Recruiting
        • Radboudumc ( Site 1504)
        • Contact:
          • Study Coordinator
          • Phone Number: + 31243610353
    • South Holland
      • Leiden, South Holland, Netherlands, 2333 ZA
        • Recruiting
        • Leids Universitair Medisch Centrum ( Site 1503)
        • Contact:
          • Study Coordinator
          • Phone Number: +31715566376
  • South Korea
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System ( Site 2501)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-2228-0831
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center ( Site 2500)
        • Contact:
          • Study Coordinator
          • Phone Number: +82230103214
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, South Korea, 10408
        • Recruiting
        • National Cancer Center ( Site 2505)
        • Contact:
          • Study Coordinator
          • Phone Number: +82319201694
      • Suwon, Kyonggi-do, South Korea, 16499
        • Recruiting
        • Ajou University Hospital ( Site 2504)
        • Contact:
          • Study Coordinator
          • Phone Number: +8216886114
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea, 28644
        • Recruiting
        • Chungbuk National University Hospital ( Site 2502)
        • Contact:
          • Study Coordinator
          • Phone Number: +82432696015
    • Taegu-Kwangyokshi
      • Daegu, Taegu-Kwangyokshi, South Korea, 42601
        • Recruiting
        • Keimyung University Dongsan Hospital ( Site 2503)
        • Contact:
          • Study Coordinator
          • Phone Number: +82532586671
  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos ( Site 1810)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913303000x484835
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz ( Site 1808)
        • Contact:
          • Study Coordinator
          • Phone Number: +34917277516
      • Madrid, Spain, 28007
        • Recruiting
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1803)
        • Contact:
          • Study Coordinator
          • Phone Number: +34915868115
      • Seville, Spain, 41007
        • Recruiting
        • Hospital Universitario Virgen Macarena ( Site 1805)
        • Contact:
          • Study Coordinator
          • Phone Number: +34955008000
    • Gerona
      • Girona, Gerona, Spain, 17007
        • Recruiting
        • Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 1807)
        • Contact:
          • Study Coordinator
          • Phone Number: +34972225834
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46009
        • Recruiting
        • Fundación Instituto Valenciano de Oncología ( Site 1809)
        • Contact:
          • Study Coordinator
          • Phone Number: +34961114230
  • Taiwan
      • New Taipei City, Taiwan, 23561
        • Recruiting
        • Taipei Medical University Shuang Ho Hospital ( Site 2612)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-970-747-515
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital ( Site 2601)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-6-2353535#3120
      • Taipei, Taiwan, 10449
        • Recruiting
        • Mackay Memorial Hospital ( Site 2611)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-2543-3535
      • Taipei, Taiwan, 114
        • Recruiting
        • Tri-Service General Hospital ( Site 2608)
        • Contact:
          • Study Coordinator
          • Phone Number: +886287923311
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri ( Site 1900)
        • Contact:
          • Study Coordinator
          • Phone Number: +903123052841
  • Ukraine
      • Kyiv, Ukraine, 03057
        • Recruiting
        • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 2005)
        • Contact:
          • Study Coordinator
          • Phone Number: +380669472333
    • Chernivetska Oblast
      • Chernivtsi, Chernivetska Oblast, Ukraine, 58013
        • Recruiting
        • Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 2002)
        • Contact:
          • Study Coordinator
          • Phone Number: +380505144910
    • Dnipropetrovsk Oblast
      • Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine, 50000
        • Recruiting
        • Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2012)
        • Contact:
          • Study Coordinator
          • Phone Number: +380973567855
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
        • Recruiting
        • Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 2006)
        • Contact:
          • Study Coordinator
          • Phone Number: +380342540325
    • Kirovohrad Oblast
      • Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25006
        • Recruiting
        • Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 2013)
        • Contact:
          • Study Coordinator
          • Phone Number: +380969680396
      • Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25011
        • Recruiting
        • Ukrainian Center of Tomotherapy ( Site 2014)
        • Contact:
          • Study Coordinator
          • Phone Number: +380676239652
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 03680
        • Recruiting
        • Shalimov Institute of Surgery and Transplantation ( Site 2003)
        • Contact:
          • Study Coordinator
          • Phone Number: +380933333911
    • Lviv Oblast
      • Lviv, Lviv Oblast, Ukraine, 79031
        • Recruiting
        • Lviv Oncology Regional Treatment and Diagnostic Center ( Site 2009)
        • Contact:
          • Study Coordinator
          • Phone Number: +380975814015
      • Lviv, Lviv Oblast, Ukraine, 79059
        • Recruiting
        • Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2000)
        • Contact:
          • Study Coordinator
          • Phone Number: +380977453295
    • Odesa Oblast
      • Odesa, Odesa Oblast, Ukraine, 65025
        • Recruiting
        • Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2011)
        • Contact:
          • Study Coordinator
          • Phone Number: +380972147211
    • Rivne Oblast
      • Rivne, Rivne Oblast, Ukraine, 33010
        • Recruiting
        • ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: +380971921000
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21029
        • Recruiting
        • Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 2004)
        • Contact:
          • Study Coordinator
          • Phone Number: +380432511160
    • Volyn Oblast
      • Lutsk, Volyn Oblast, Ukraine, 43018
        • Recruiting
        • Volyn Regional Clinical Hospital ( Site 2010)
        • Contact:
          • Study Coordinator
          • Phone Number: +380503782998
  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Recruiting
        • NHO Revive Research Institute LLC ( Site 0118)
        • Contact:
          • Study Coordinator
          • Phone Number: 402-484-4900
    • New York
      • Albany, New York, United States, 12206
        • Recruiting
        • New York Oncology Hematology P.C ( Site 9000)
        • Contact:
          • Study Coordinator
          • Phone Number: 518-489-0044

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

  • Has 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).
  • 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.

Exclusion Criteria:

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.
  • 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.

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
Experimental: Calderasib + Durvalumab
Participants will receive calderasib and durvalumab.
Drug: Calderasib
Tablet for oral administration.
Other Names:
  • MK-1084
Biological: Durvalumab
Solution for intravenous (IV) infusion.
Other Names:
  • IMFINZI®
Active Comparator: Placebo + Durvalumab
Participants will receive placebo to calderasib and durvalumab.
Biological: Durvalumab
Solution for intravenous (IV) infusion.
Other Names:
  • IMFINZI®
Other: Placebo to MK-1084
Placebo to 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 6 years
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Up to approximately 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 9 years
OS is defined as the time from randomization to death due to any cause.
Up to approximately 9 years
Number of Participants Who Experience an Adverse Events (AEs)
Time Frame: Up to approximately 9 years
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 9 years
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 9 years
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 9 years
Objective Response Rate (ORR)
Time Frame: Up to approximately 9 years
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.
Up to approximately 9 years
Duration of Response (DOR)
Time Frame: Up to approximately 9 years
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 9 years
Distant Metastasis-Free Survival (DMFS)
Time Frame: Up to approximately 9 years
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.
Up to approximately 9 years
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
Time Frame: Baseline and up to approximately 9 years
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.
Baseline and up to approximately 9 years
Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score
Time Frame: Baseline and up to approximately 9 years
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.
Baseline and up to approximately 9 years
Change from Baseline in Role Functioning (EORTC QLQ-C30 Items 6 & 7) Combined Score
Time Frame: Baseline and up to approximately 9 years
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.
Baseline and up to approximately 9 years

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)

June 18, 2026

Primary Completion (Estimated)

December 15, 2032

Study Completion (Estimated)

August 17, 2037

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1084-015
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-522038-29-00 (Registry Identifier: EU CT)
  • U1111-1321-6971 (Registry Identifier: UTN)
  • MK-1084-015 (Other Identifier: MSD)
  • KANDLELIT-015 (Other Identifier: MSD)
  • jRCT2021260021 (Registry Identifier: jRCT)

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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