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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)

Status: Recruiting
Location: See all (95) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Argentina
Centro de Educación Médica e Investigaciones clínicas Dr. Norberto Quirno (CEMIC) ( Site 0309)
RECRUITING
Caba
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0306)
RECRUITING
Caba
Instituto Alexander Fleming ( Site 0310)
RECRUITING
Ciudad Autónoma De Buenos Aires
Sanatorio Parque ( Site 0311)
RECRUITING
Rosario
Australia
Peninsula University Hospital ( Site 3011)
RECRUITING
Frankston
Northern Beaches Hospital ( Site 3009)
RECRUITING
Frenchs Forest
Brazil
PRONUTRIR ( Site 0425)
RECRUITING
Fortaleza
Faculdade de Medicina do ABC ( Site 0415)
RECRUITING
Santo André
Hospital Alemao Oswaldo Cruz ( Site 0416)
RECRUITING
São Paulo
Canada
Moncton Hospital ( Site 0200)
RECRUITING
Moncton
Centre Hospitalier de l'Université de Montréal ( Site 0219)
RECRUITING
Montreal
Chile
Centro de Oncología de Precisión-Oncology ( Site 0503)
RECRUITING
Las Condes
Clínica MEDS La Dehesa ( Site 0509)
RECRUITING
Lo Barnechea
FALP ( Site 0501)
RECRUITING
Santiago
China
Beijing Cancer hospital ( Site 2106)
RECRUITING
Beijing
Peking Union Medical College Hospital ( Site 2105)
RECRUITING
Beijing
Peking University People's Hospital ( Site 2100)
RECRUITING
Beijing
Xiangya Hospital Central South University ( Site 2136)
RECRUITING
Changsha
Sichuan Cancer hospital ( Site 2101)
RECRUITING
Chengdu
The Third Peoples Hospital Of Chengdu ( Site 2141)
RECRUITING
Chengdu
West China Hospital, Sichuan University ( Site 2142)
RECRUITING
Chengdu
Chongqing University Three Gorges Hospital ( Site 2138)
RECRUITING
Chongqing
Fujian Cancer Hospital ( Site 2122)
RECRUITING
Fuzhou
The First Affiliated Hospital Of Fujian Medical University ( Site 2123)
RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center ( Site 2134)
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 2118)
RECRUITING
Hangzhou
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 2103)
RECRUITING
Hangzhou
Zhejiang Cancer Hospital ( Site 2117)
RECRUITING
Hangzhou
Fourth Hospital Of Hebei Medical University ( Site 2107)
RECRUITING
Hshijiazhuang
Yunnan Province Cancer Hospital ( Site 2131)
RECRUITING
Kunming
The First Affiliated Hospital of Nanchang University ( Site 2121)
RECRUITING
Nanchang
Guangxi Medical University Cancer Hospital ( Site 2115)
RECRUITING
Nanning
Ningbo No. 2 Hospital ( Site 2124)
RECRUITING
Ningbo
Fudan University Shanghai Cancer Center ( Site 2137)
RECRUITING
Shanghai
Shanghai Pulmonary Hospital ( Site 2125)
RECRUITING
Shanghai
Zhongshan Hospital of Fudan University ( Site 2119)
RECRUITING
Shanghai
The Affiliated Cancer Hospital of Xinjiang Medical ( Site 2110)
RECRUITING
Urumuqi
Tongji Hospital Tongji Medical,Science & Technology ( Site 2140)
RECRUITING
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 2139)
RECRUITING
Wuhan
France
Centre de Cancérologie du Grand Montpellier ( Site 1016)
RECRUITING
Montpellier
Greece
Athens Medical Center ( Site 1202)
RECRUITING
Athens
Errikos Dunant Hospital Center ( Site 1201)
RECRUITING
Athens
Evangelismos General Hospital of Athens ( Site 1204)
RECRUITING
Athens
THORACIC GENERAL HOSPITAL OF ATHENS I SOTIRIA ( Site 1206)
RECRUITING
Athens
Metaxa Cancer Hospital of Piraeus ( Site 1207)
RECRUITING
Piraeus
G. Papanikolaou General Hospital ( Site 1203)
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Queen Mary Hospital ( Site 3100)
RECRUITING
Hong Kong
Tuen Mun Hospital ( Site 3102)
RECRUITING
Hong Kong
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1400)
RECRUITING
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1401)
RECRUITING
Roma
Japan
Fukushima Medical University Hospital ( Site 2202)
RECRUITING
Fukushima
Republic of Korea
Keimyung University Dongsan Hospital ( Site 3605)
RECRUITING
Daegu
National Cancer Center ( Site 3603)
RECRUITING
Goyang-si
Asan Medical Center ( Site 3600)
RECRUITING
Seoul
Severance Hospital Yonsei University Health System ( Site 3601)
RECRUITING
Seoul
The Catholic University of Korea St. Vincent s Hospital ( Site 3602)
RECRUITING
Suwon
Spain
Hospital Universitari Vall d'Hebron ( Site 1700)
RECRUITING
Barcelona
Institut Català d'Oncologia (ICO) - Girona ( Site 1703)
RECRUITING
Girona
Hospital Insular de Gran Canaria ( Site 1704)
RECRUITING
Las Palmas De Gran Canaria
Hospital Clinico San Carlos ( Site 1706)
RECRUITING
Madrid
Hospital Universitario la Paz ( Site 1710)
RECRUITING
Madrid
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1707)
RECRUITING
Madrid
Hospital Puerta de Hierro ( Site 1705)
RECRUITING
Majadahonda
H.R.U Malaga - Hospital General ( Site 1708)
RECRUITING
Málaga
Hospital Universitario Virgen Macarena ( Site 1709)
RECRUITING
Seville
Taiwan
Taipei Medical University Shuang Ho Hospital ( Site 3700)
RECRUITING
New Taipei City
National Cheng Kung University Hospital ( Site 3706)
RECRUITING
Tainan
Mackay Memorial Hospital ( Site 3701)
RECRUITING
Taipei
Tri-Service General Hospital ( Site 3708)
RECRUITING
Taipei
Turkey
Adana Medical Park Seyhan Hastanesi ( Site 1827)
RECRUITING
Adana
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1812)
RECRUITING
Adana
Ankara Atatürk Sanatoryum Eğitim ve Araştırma Hastanesi ( Site 1825)
RECRUITING
Ankara
Ankara Bilkent Şehir Hastanesi ( Site 1811)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri ( Site 1810)
RECRUITING
Ankara
Liv Hospital Ankara ( Site 1828)
RECRUITING
Ankara
Kartal Lütfi Kırdar Şehir Hastanesi ( Site 1826)
RECRUITING
Istanbul
İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 1815)
RECRUITING
Malatya
Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 1824)
RECRUITING
Mersin
Recep Tayyip Erdogan University Training and Research Hospital ( Site 1816)
RECRUITING
Rize
Sakarya Egitim ve Arastırma Hastanesi ( Site 1817)
RECRUITING
Sakarya
Ukraine
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 1904)
RECRUITING
Cherkasy
Regional Municipal Non-profit Enterprise Bukovinian Clinical Oncology Center ( Site 1909)
RECRUITING
Chernivtsi
Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio ( Site 1900)
RECRUITING
Ivano-frankivsk
Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 1916)
RECRUITING
Kropyvnytskyi
Ukrainian Center of Tomotherapy ( Site 1917)
RECRUITING
Kropyvnytskyi
Medical Center Mriya Med-Service ( Site 1911)
RECRUITING
Kryvyi Rih
Medical Center Universal Clinic Oberig of Limited Liability Company Kapytal ( Site 1915)
RECRUITING
Kyiv
Shalimov Institute of Surgery and Transplantation ( Site 1907)
RECRUITING
Kyiv
Municipal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council ( Site 1914)
RECRUITING
Lutsk
Communal noncommercial enterprise of Lviv regional council Lviv oncological regional therapeutical ( Site 1908)
RECRUITING
Lviv
Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 1902)
RECRUITING
Lviv
Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 1913)
RECRUITING
Odesa
ME Rivne Regional Antitumor Center Rivne Regional Council ( Site 1912)
RECRUITING
Rivne
Communal Noncommercial Enterprise Podillia Regional Oncology Center Of Vinnytsia Regional Council ( Site 1903)
RECRUITING
Vinnytsia
United Kingdom
Queen Alexandra Hospital ( Site 2011)
RECRUITING
Portsmouth
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2026-03-18
Estimated Completion Date: 2039-10-26
Participants
Target number of participants: 400
Treatments
Experimental: Calderasib + MK-3475A
Participants receive calderasib daily (qd) and MK-3475A every 6 weeks (q6w) for up to 9 doses.
Active_comparator: Placebo + MK-3475A
Participants receive placebo qd and MK-3475A q6w for up to 9 doses.
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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