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NCT07554339PHASE3Recruiting

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

Merck Sharp & Dohme LLC

Start Date

6/18/2026

Completion Date

8/17/2037

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Calderasib

BIOLOGICAL

Durvalumab

OTHER

Placebo to MK-1084

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Conditions

Non-small Cell Lung Cancer

Locations

NHO Revive Research Institute LLC ( Site 0118)

Lincoln, Nebraska 68506

United States

New York Oncology Hematology P.C ( Site 9000)

Albany, New York 12206

United States

Clinica Adventista Belgrano ( Site 0304)

Ciudad Autonoma de Buenos Aires, Buenos Aires C1430EGF

Argentina

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303)

Mar del Plata, Buenos Aires B7600FZO

Argentina

Hospital Britanico de Buenos Aires ( Site 0305)

Buenos Aires, Buenos Aires F.D. C1280AEB

Argentina

Sanatorio Parque ( Site 0302)

Rosario, Santa Fe Province S2000DSV

Argentina

Zhongshan Hospital Affiliated to Xiamen University ( Site 2213)

Xiamen, Fujian 361000

China

The First Affiliated Hospital of Xiamen University. ( Site 2239)

Xiamen, Fujian 361003

China

Guangxi Medical University Affiliated Tumor Hospital ( Site 2202)

Qingxiu District, Guangxi 530022

China

Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2206)

Wuhan, Hubei 430048

China

Hubei Cancer Hospital ( Site 2203)

Wuhan, Hubei 430070

China

Nanjing Drum Tower Hospital ( Site 2224)

Nanjing, Jiangsu 210000

China

Shandong Cancer Hospital ( Site 2200)

Jinan, Shandong 250117

China

Zhongshan Hospital affiliated to Fudan University ( Site 2215)

Shanghai, Shanghai Municipality 200030

China

Shanxi Provincial Cancer Hospital ( Site 2227)

Taiyuan, Shanxi 030013

China

Sichuan Cancer hospital. ( Site 2218)

Chengdu, Sichuan 610213

China

Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1108)

Münster, North Rhine-Westphalia 48153

Germany

Athens Medical Center ( Site 1201)

Athens, Attica 151 25

Greece

Metaxa Cancer Hospital of Piraeus ( Site 1203)

Piraeus, Attica 185 37

Greece

University General Hospital of Alexandroupoli ( Site 1206)

Alexandroupoli, East Macedonia and Thrace 681 00

Greece

Radboudumc ( Site 1504)

Nijmegen, Gelderland 6525 GA

Netherlands

Leids Universitair Medisch Centrum ( Site 1503)

Leiden, South Holland 2333 ZA

Netherlands

University Medical Center Groningen ( Site 1505)

Groningen, 9713 GZ

Netherlands

National Cancer Center ( Site 2505)

Goyang-si, Kyonggi-do 10408

South Korea

Ajou University Hospital ( Site 2504)

Suwon, Kyonggi-do 16499

South Korea

Chungbuk National University Hospital ( Site 2502)

Cheongju-si, North Chungcheong 28644

South Korea

Keimyung University Dongsan Hospital ( Site 2503)

Daegu, Taegu-Kwangyokshi 42601

South Korea

Severance Hospital, Yonsei University Health System ( Site 2501)

Seoul, 03722

South Korea

Asan Medical Center ( Site 2500)

Seoul, 05505

South Korea

Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 1807)

Girona, Gerona 17007

Spain

Fundación Instituto Valenciano de Oncología ( Site 1809)

Valencia, Valenciana, Comunitat 46009

Spain

Hospital Clinico San Carlos ( Site 1810)

Madrid, 28040

Spain

Hospital Universitario La Paz ( Site 1808)

Madrid, 28046

Spain

Hospital Universitario Virgen Macarena ( Site 1805)

Seville, 41007

Spain

Taipei Medical University Shuang Ho Hospital ( Site 2612)

New Taipei City, 23561

Taiwan

National Cheng Kung University Hospital ( Site 2601)

Tainan, 704

Taiwan

Mackay Memorial Hospital ( Site 2611)

Taipei, 10449

Taiwan

Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 2002)

Chernivtsi, Chernivetska Oblast 58013

Ukraine

Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2012)

Kryvyi Rih, Dnipropetrovsk Oblast 50000

Ukraine

Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 2006)

Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018

Ukraine

Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 2013)

Kropyvnytskyi, Kirovohrad Oblast 25006

Ukraine

Ukrainian Center of Tomotherapy ( Site 2014)

Kropyvnytskyi, Kirovohrad Oblast 25011

Ukraine

Shalimov Institute of Surgery and Transplantation ( Site 2003)

Kyiv, Kyivska Oblast 03680

Ukraine

Lviv Oncology Regional Treatment and Diagnostic Center ( Site 2009)

Lviv, Lviv Oblast 79031

Ukraine

Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2000)

Lviv, Lviv Oblast 79059

Ukraine

Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2011)

Odesa, Odesa Oblast 65025

Ukraine

ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2001)

Rivne, Rivne Oblast 33010

Ukraine

Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 2004)

Vinnytsia, Vinnytsia Oblast 21029

Ukraine

Volyn Regional Clinical Hospital ( Site 2010)

Lutsk, Volyn Oblast 43018

Ukraine

Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 2005)

Kyiv, 03057

Ukraine