MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) (KANDLELIT-013)

June 1, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Adjuvant Placebo Plus MK-3475A in Participants With Completely Resected Stage IIA-IIIB (N2), KRAS G12C-mutant Non-small Cell Lung Cancer Following Receipt of Either Neoadjuvant Pembrolizumab Plus Chemotherapy or Adjuvant Chemotherapy (KANDLELIT-013)

This is a phase 3, randomized, double-blind study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy. The primary goal of the study is to compare adjuvant calderasib plus MK-3475A to adjuvant placebo plus MK-3475A with respect to disease-free survival (DFS) as assessed by the investigator.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

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
      • CABA, Argentina, C1431FWO
        • Recruiting
        • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0309)
        • Contact:
          • Study Coordinator
          • Phone Number: +5491160006609
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming ( Site 0310)
        • Contact:
          • Study Coordinator
          • Phone Number: +541132218900
  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 404199
        • Recruiting
        • Chongqing University Three Gorges Hospital ( Site 2138)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613896327099
    • Guangxi
      • Nanning, Guangxi, China, 530201
        • Recruiting
        • Guangxi Medical University Cancer Hospital ( Site 2115)
        • Contact:
          • Study Coordinator
          • Phone Number: 0771-5310848
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Sichuan Cancer hospital ( Site 2101)
        • Contact:
          • Study Coordinator
          • Phone Number: +8663066886
      • Chengdu, Sichuan, China, 610031
        • Recruiting
        • The Third Peoples Hospital Of Chengdu ( Site 2141)
        • Contact:
          • Study Coordinator
          • Phone Number: +8602861318720
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital ( Site 3100)
        • Contact:
          • Study Coordinator
          • Phone Number: 85239103299
  • South Korea
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital Yonsei University Health System ( Site 3601)
        • Contact:
          • Study Coordinator
          • Phone Number: +8215991004
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center ( Site 3600)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-3010-3214
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, South Korea, 10408
        • Recruiting
        • National Cancer Center ( Site 3603)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-31-920-1676
      • Suwon, Kyonggi-do, South Korea, 16247
        • Recruiting
        • The Catholic University of Korea St. Vincent s Hospital ( Site 3602)
        • Contact:
          • Study Coordinator
          • Phone Number: +82 31 249 8485
    • Taegu-Kwangyokshi
      • Daegu, Taegu-Kwangyokshi, South Korea, 42601
        • Recruiting
        • Keimyung University Dongsan Hospital ( Site 3605)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-53-258-6671
  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario la Paz ( Site 1710)
        • Contact:
          • Study Coordinator
          • Phone Number: +34917277516
      • Madrid, Spain, 28223
        • Recruiting
        • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1707)
        • Contact:
          • Study Coordinator
          • Phone Number: 913303000
    • Gerona
      • Girona, Gerona, Spain, 17007
        • Recruiting
        • Institut Català d'Oncologia (ICO) - Girona ( Site 1703)
        • Contact:
          • Study Coordinator
          • Phone Number: +34972225834
  • Taiwan
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital ( Site 3706)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-6-2353535#3120
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06280
        • Recruiting
        • Ankara Atatürk Sanatoryum Eğitim ve Araştırma Hastanesi ( Site 1825)
        • Contact:
          • Study Coordinator
          • Phone Number: +9005360653456
      • Ankara, Turkey (Türkiye), 06410
        • Recruiting
        • Hacettepe Universite Hastaneleri ( Site 1810)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 5415762496
      • Ankara, Turkey (Türkiye), 6680
        • Recruiting
        • Liv Hospital Ankara ( Site 1828)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 5520045315
      • Istanbul, Turkey (Türkiye), 34865
        • Recruiting
        • Kartal Lütfi Kırdar Şehir Hastanesi ( Site 1826)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 536 719 73 95
      • Malatya, Turkey (Türkiye), 44280
        • Recruiting
        • İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 1815)
        • Contact:
          • Study Coordinator
          • Phone Number: +905396194044
      • Mersin, Turkey (Türkiye), 33240
        • Recruiting
        • Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 1824)
        • Contact:
          • Study Coordinator
          • Phone Number: +905074436940
  • Ukraine
      • Kyiv, Ukraine, 03057
        • Recruiting
        • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1915)
        • Contact:
          • Study Coordinator
          • Phone Number: +380669472333
      • Kyiv, Ukraine, 03126
        • Recruiting
        • Shalimov Institute of Surgery and Transplantation ( Site 1907)
        • Contact:
          • Study Coordinator
          • Phone Number: +380444081800
    • Cherkasy Oblast
      • Cherkasy, Cherkasy Oblast, Ukraine, 18009
        • Recruiting
        • COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 1904)
        • Contact:
          • Study Coordinator
          • Phone Number: +380472370123
    • Chernivetska Oblast
      • Chernivtsi, Chernivetska Oblast, Ukraine, 58013
        • Recruiting
        • Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 1909)
        • Contact:
          • Study Coordinator
          • Phone Number: +380505144910
    • Dnipropetrovsk Oblast
      • Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine, 50000
        • Recruiting
        • Medical Center "Mriya Med-Service" ( Site 1911)
        • Contact:
          • Study Coordinator
          • Phone Number: +380677490687
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
        • Recruiting
        • Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio ( Site 1900)
        • Contact:
          • Study Coordinator
          • Phone Number: +380342507353
    • Kirovohrad Oblast
      • Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25006
        • Recruiting
        • Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 1916)
        • Contact:
          • Study Coordinator
          • Phone Number: +380969680396
      • Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25011
        • Recruiting
        • Ukrainian Center of Tomotherapy ( Site 1917)
        • Contact:
          • Study Coordinator
          • Phone Number: +380958718674
    • Lviv Oblast
      • Lviv, Lviv Oblast, Ukraine, 79031
        • Recruiting
        • Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutical ( Site 1908)
        • Contact:
          • Study Coordinator
          • Phone Number: +380973342609
      • Lviv, Lviv Oblast, Ukraine, 79059
        • Recruiting
        • Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 1902)
        • 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 1913)
        • Contact:
          • Study Coordinator
          • Phone Number: +380931860876
    • Rivne Oblast
      • Rivne, Rivne Oblast, Ukraine, 33010
        • Recruiting
        • ME "Rivne Regional Antitumor Center" Rivne Regional Council ( Site 1912)
        • 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 1903)
        • Contact:
          • Study Coordinator
          • Phone Number: +380988936318
    • Volyn Oblast
      • Lutsk, Volyn Oblast, Ukraine, 43018
        • Recruiting
        • Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council ( Site 1914)
        • Contact:
          • Study Coordinator
          • Phone Number: +380332773100

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:

  • Has a histological/cytological diagnosis of non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology and meets one of the following criteria:

    • Has newly diagnosed, treatment-naïve, resectable, clinical Stage IIA-IIIB (N2) NSCLC
    • Has completely resected, pathological Stage IIA-IIIB (N2) NSCLC, including those previously treated outside the study with neoadjuvant platinum-doublet chemotherapy plus pembrolizumab or MK-3475A, or those who received adjuvant platinum-doublet chemotherapy.
  • Tumor tissue shows the presence of Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
  • No more than 12 weeks have elapsed between either the surgery following neoadjuvant treatment or last dose of adjuvant platinum-based chemotherapy and the first dose of investigational adjuvant study intervention.
  • Has no evidence of disease based on postsurgical radiological assessment as documented by contrast-enhanced chest/abdomen computed tomography (or magnetic resonance imaging) within 28 days before randomization
  • Has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 10 days before the first dose of the study intervention
  • Human immunodeficiency virus-infected participants must have well controlled HIV on antiretroviral therapy
  • Participants who are Hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

  • Has a diagnosis of any 1 of the following tumor types/locations: small cell lung cancer or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or NSCLC involving the superior sulcus
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention
  • Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, or malabsorption)
  • Has 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 except replacement therapy
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has active infection requiring systemic therapy
  • 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
Active Comparator: Placebo + MK-3475A
Participants receive placebo qd and MK-3475A q6w for up to 9 doses.
Drug: Placebo
Placebo oral tablet
Biological: MK-3475A
Fixed dose coformulated product of hyaluronidase/pembrolizumab administered via SC injection.
Other Names:
  • Pembrolizumab (+) Berahyaluronidase alfa
Experimental: Calderasib + MK-3475A
Participants receive calderasib daily (qd) and MK-3475A every 6 weeks (q6w) for up to 9 doses.
Biological: MK-3475A
Fixed dose coformulated product of hyaluronidase/pembrolizumab administered via SC injection.
Other Names:
  • Pembrolizumab (+) Berahyaluronidase alfa
Drug: Calderasib
MK-1084 oral tablet
Other Names:
  • MK-1084

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free Survival (DFS)
Time Frame: Up to ~11 years
DFS is the time from randomization to any recurrence (local, locoregional, regional, or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
Up to ~11 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to ~11 years
OS is the time from randomization to death due to any cause.
Up to ~11 years
Distant Metastasis-Free Survival (DMFS)
Time Frame: Up to ~11 years
DMFS is the time from randomization to the first documented distant metastasis or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.
Up to ~11 years
Lung Cancer Specific Survival (LCSS)
Time Frame: Up to ~11 years
LCSS is the time from randomization to the date of death due to lung cancer.
Up to ~11 years
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
Time Frame: Up to ~11 years
Change from baseline in Global health status/QoL score (QLQ-C30 Items 29 and 30).
Up to ~11 years
Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score
Time Frame: Up to ~11 years
Change from baseline in physical functioning score (QLQ-C30 Items 1 to 5).
Up to ~11 years
Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
Time Frame: Up to ~11 years
Change from baseline in role functioning score (QLQ-C30 Items 6 and 7).
Up to ~11 years
Change from Baseline in the EORTC-QLQ-C30 Dyspnea (Item 8) Score
Time Frame: Up to ~11 years
Change from baseline in dyspnea (QLQ-C30 Item 8).
Up to ~11 years
Change from Baseline in the EORTC-Quality of Life Questionnaire-Lung Cancer 24 (QLQ-LC24) Coughing (Items 31 and 52) Combined Score
Time Frame: Up to ~11 years
Change from baseline in coughing scores (EORTC QLQ-LC24 Items 31 and 52).
Up to ~11 years
Change from Baseline in the EORTC-QLQ-LC24 Chest Pain (Item 40) Score
Time Frame: Up to ~11 years
Change from baseline in chest pain score (EORTC QLQ-LC24 Item 40).
Up to ~11 years
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to ~13.5 years
Number of participants with ≥1 AE.
Up to ~13.5 years
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to ~13.5 years
Number of participants discontinuing from study therapy due to AE.
Up to ~13.5 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)

March 18, 2026

Primary Completion (Estimated)

October 26, 2039

Study Completion (Estimated)

October 26, 2039

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1084-013
  • U1111-1312-0627 (Registry Identifier: UTN)
  • 2024-517337-41-00 (Registry Identifier: EU CT)

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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