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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)

Status: Recruiting
Location: See all (63) locations...
Intervention Type: Drug, Biological, Other
Study Type: Interventional
Study Phase: Phase 3
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. 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.

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

⁃ 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.

Locations
United States
Nebraska
NHO Revive Research Institute LLC ( Site 0118)
RECRUITING
Lincoln
New York
New York Oncology Hematology P.C ( Site 9000)
RECRUITING
Albany
Other Locations
Argentina
Hospital Britanico de Buenos Aires ( Site 0305)
RECRUITING
Buenos Aires
Clinica Adventista Belgrano ( Site 0304)
RECRUITING
Ciudad Autonoma De Buenos Aires
Instituto Alexander Fleming ( Site 0301)
RECRUITING
Ciudad Autonoma De Buenos Aires.
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303)
RECRUITING
Mar Del Plata
Sanatorio Parque ( Site 0302)
RECRUITING
Rosario
Australia
Northern Beaches Hospital ( Site 2401)
RECRUITING
Frenchs Forest
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0401)
RECRUITING
Barretos
AFECC ASSOCIACAO FEMININA EDUCACAO COMBATE CANCER ( Site 0416)
RECRUITING
Vitória
China
The Second Xiangya Hospital Of Central South University ( Site 2207)
RECRUITING
Changsha
Sichuan Cancer hospital. ( Site 2218)
RECRUITING
Chengdu
Anhui Provincial Cancer Hospital ( Site 2209)
RECRUITING
Hefei
Shandong Cancer Hospital ( Site 2200)
RECRUITING
Jinan
Nanjing Drum Tower Hospital ( Site 2224)
RECRUITING
Nanjing
Guangxi Medical University Affiliated Tumor Hospital ( Site 2202)
RECRUITING
Qingxiu District
Zhongshan Hospital affiliated to Fudan University ( Site 2215)
RECRUITING
Shanghai
Shanxi Provincial Cancer Hospital ( Site 2227)
RECRUITING
Taiyuan
Hubei Cancer Hospital ( Site 2203)
RECRUITING
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2206)
RECRUITING
Wuhan
The First Affiliated Hospital of Xiamen University. ( Site 2239)
RECRUITING
Xiamen
Zhongshan Hospital Affiliated to Xiamen University ( Site 2213)
RECRUITING
Xiamen
France
Clinique Teissier Groupe ( Site 1006)
RECRUITING
Valenciennes
Germany
Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1108)
RECRUITING
Münster
Greece
University General Hospital of Alexandroupoli ( Site 1206)
RECRUITING
Alexandroupoli
ALEXANDRA General Hospital of Athens ( Site 1200)
RECRUITING
Athens
Athens Medical Center ( Site 1201)
RECRUITING
Athens
Metaxa Cancer Hospital of Piraeus ( Site 1203)
RECRUITING
Piraeus
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1401)
RECRUITING
Rome
Japan
Sendai Kousei Hospital ( Site 2300)
RECRUITING
Sendai
Netherlands
University Medical Center Groningen ( Site 1505)
RECRUITING
Groningen
Leids Universitair Medisch Centrum ( Site 1503)
RECRUITING
Leiden
Radboudumc ( Site 1504)
RECRUITING
Nijmegen
Republic of Korea
Chungbuk National University Hospital ( Site 2502)
RECRUITING
Cheongju-si
Keimyung University Dongsan Hospital ( Site 2503)
RECRUITING
Daegu
National Cancer Center ( Site 2505)
RECRUITING
Goyang-si
Asan Medical Center ( Site 2500)
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System ( Site 2501)
RECRUITING
Seoul
Ajou University Hospital ( Site 2504)
RECRUITING
Suwon
Spain
Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 1807)
RECRUITING
Girona
Hospital Clinico San Carlos ( Site 1810)
RECRUITING
Madrid
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1803)
RECRUITING
Madrid
Hospital Universitario La Paz ( Site 1808)
RECRUITING
Madrid
Hospital Universitario Virgen Macarena ( Site 1805)
RECRUITING
Seville
Fundación Instituto Valenciano de Oncología ( Site 1809)
RECRUITING
Valencia
Taiwan
Taipei Medical University Shuang Ho Hospital ( Site 2612)
RECRUITING
New Taipei City
National Cheng Kung University Hospital ( Site 2601)
RECRUITING
Tainan
Mackay Memorial Hospital ( Site 2611)
RECRUITING
Taipei
Tri-Service General Hospital ( Site 2608)
RECRUITING
Taipei
Turkey
Hacettepe Universite Hastaneleri ( Site 1900)
RECRUITING
Ankara
Ukraine
Regional Municipal Non-profit Enterprise Bukovinian Clinical Oncology Center ( Site 2002)
RECRUITING
Chernivtsi
Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Reg ( Site 2006)
RECRUITING
Ivano-frankivsk
Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 2013)
RECRUITING
Kropyvnytskyi
Ukrainian Center of Tomotherapy ( Site 2014)
RECRUITING
Kropyvnytskyi
Medical Center Mriya Med-Service-Clinical Research Department ( Site 2012)
RECRUITING
Kryvyi Rih
Medical Center Universal Clinic Oberig of Limited Liability Company Kapytal ( Site 2005)
RECRUITING
Kyiv
Shalimov Institute of Surgery and Transplantation ( Site 2003)
RECRUITING
Kyiv
Volyn Regional Clinical Hospital ( Site 2010)
RECRUITING
Lutsk
Lviv Oncology Regional Treatment and Diagnostic Center ( Site 2009)
RECRUITING
Lviv
Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2000)
RECRUITING
Lviv
Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2011)
RECRUITING
Odesa
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2001)
RECRUITING
Rivne
Communal Noncommercial Enterprise Podillia Regional Oncology Center Of Vinnytsia Regional Council ( Site 2004)
RECRUITING
Vinnytsia
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2026-06-18
Estimated Completion Date: 2037-08-17
Participants
Target number of participants: 310
Treatments
Experimental: Calderasib + Durvalumab
Participants will receive calderasib and durvalumab.
Active_comparator: Placebo + Durvalumab
Participants will receive placebo to calderasib and durvalumab.
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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