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RECRUITING
NCT07431827
PHASE3

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2026-03-18

Completion Date

2039-10-26

Last Updated

2026-05-11

Healthy Volunteers

No

Interventions

DRUG

Calderasib

MK-1084 oral tablet

BIOLOGICAL

MK-3475A

Fixed dose coformulated product of hyaluronidase/pembrolizumab administered via SC injection.

DRUG

Placebo

Placebo oral tablet

Locations (24)

Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0309)

CABA, Argentina

Guangxi Medical University Cancer Hospital ( Site 2115)

Nanning, Guangxi, China

Sichuan Cancer hospital ( Site 2101)

Chengdu, Sichuan, China

The Third Peoples Hospital Of Chengdu ( Site 2141)

Chengdu, Sichuan, China

Queen Mary Hospital ( Site 3100)

Hong Kong, Hong Kong

National Cancer Center ( Site 3603)

Goyang-si, Kyonggi-do, South Korea

Keimyung University Dongsan Hospital ( Site 3605)

Daegu, Taegu-Kwangyokshi, South Korea

Severance Hospital Yonsei University Health System ( Site 3601)

Seoul, South Korea

Asan Medical Center ( Site 3600)

Seoul, South Korea

National Cheng Kung University Hospital ( Site 3706)

Tainan, Taiwan

COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 1904)

Cherkasy, Cherkasy Oblast, Ukraine

Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 1909)

Chernivtsi, Chernivetska Oblast, Ukraine

Medical Center "Mriya Med-Service" ( Site 1911)

Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine

Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio ( Site 1900)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 1916)

Kropyvnytskyi, Kirovohrad Oblast, Ukraine

Ukrainian Center of Tomotherapy ( Site 1917)

Kropyvnytskyi, Kirovohrad Oblast, Ukraine

Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutical ( Site 1908)

Lviv, Lviv Oblast, Ukraine

Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 1902)

Lviv, Lviv Oblast, Ukraine

Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 1913)

Odesa, Odesa Oblast, Ukraine

ME "Rivne Regional Antitumor Center" Rivne Regional Council ( Site 1912)

Rivne, Rivne Oblast, Ukraine

Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 1903)

Vinnytsia, Vinnytsia Oblast, Ukraine

Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council ( Site 1914)

Lutsk, Volyn Oblast, Ukraine

Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1915)

Kyiv, Ukraine

Shalimov Institute of Surgery and Transplantation ( Site 1907)

Kyiv, Ukraine