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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07554339

Registry updated: 2026-10-20
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Description

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.

Interventions

  • Calderasib (Drug)
    Tablet for oral administration.
  • Durvalumab (Biological)
    Solution for intravenous (IV) infusion.
  • Placebo to MK-1084 (Other)
    Placebo to MK-1084.

Eligibility criteria

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.

Conditions

Non-small Cell Lung Cancer

Locations

  • Duly Healthcare ( Site 0158) — Lisle, Illinois, United States
  • NHO Revive Research Institute LLC ( Site 0118) — Lincoln, Nebraska, United States
  • New York Oncology Hematology P.C ( Site 9000) — Albany, New York, United States
  • WakeMed Raleigh Campus ( Site 0144) — Raleigh, North Carolina, United States
  • Virginia Cancer Specialists ( Site 0114) — Fairfax, Virginia, United States
  • Instituto Alexander Fleming ( Site 0301) — Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina
  • Hospital Italiano de Buenos Aires. ( Site 0300) — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
  • Clinica Adventista Belgrano ( Site 0304) — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303) — Mar del Plata, Buenos Aires, Argentina
  • Hospital Britanico de Buenos Aires ( Site 0305) — Buenos Aires, Buenos Aires F.D., Argentina
  • Sanatorio Parque ( Site 0302) — Rosario, Santa Fe Province, Argentina
  • Northern Beaches Hospital ( Site 2401) — Frenchs Forest, New South Wales, Australia
  • Princess Alexandra Hospital ( Site 2406) — Woolloongabba, Queensland, Australia
  • Frankston Hospital ( Site 2403) — Frankston, Victoria, Australia
  • CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0406) — Fortaleza, Ceará, Brazil
  • AFECC ASSOCIACAO FEMININA EDUCACAO COMBATE CANCER ( Site 0416) — Vitória, Espírito Santo, Brazil
  • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0401) — Barretos, São Paulo, Brazil
  • Anhui Provincial Cancer Hospital ( Site 2209) — Hefei, Anhui, China
  • Beijing Peking Union Medical College Hospital ( Site 2220) — Beijing, Beijing Municipality, China
  • Zhongshan Hospital Affiliated to Xiamen University ( Site 2213) — Xiamen, Fujian, China
  • The First Affiliated Hospital of Xiamen University. ( Site 2239) — Xiamen, Fujian, China
  • The First Affiliated Hospital of Guangzhou Medical University ( Site 2211) — Guangzhou, Guangdong, China
  • The Second Affiliated Hospital of Guilin Medical University ( Site 2212) — Guilin, Guangxi, China
  • Guangxi Medical University Cancer Hospital ( Site 2202) — Nanning, Guangxi, China
  • Fourth Hospital of Hebei Medical University ( Site 2201) — Shijiazhuang, Hebei, China
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2206) — Wuhan, Hubei, China
  • Hubei Cancer Hospital ( Site 2203) — Wuhan, Hubei, China
  • The Second Xiangya Hospital Of Central South University ( Site 2207) — Changsha, Hunan, China
  • Hunan Cancer Hospital ( Site 2214) — Changsha, Hunan, China
  • Nanjing Drum Tower Hospital ( Site 2224) — Nanjing, Jiangsu, China
  • Shandong Cancer Hospital ( Site 2200) — Jinan, Shandong, China
  • Zhongshan Hospital affiliated to Fudan University ( Site 2215) — Shanghai, Shanghai Municipality, China
  • Fudan University Shanghai Cancer Center ( Site 2216) — Shanghai, Shanghai Municipality, China
  • Shanxi Provincial Cancer Hospital ( Site 2227) — Taiyuan, Shanxi, China
  • Sichuan Cancer hospital. ( Site 2218) — Chengdu, Sichuan, China
  • Chongqing University Cancer Hospital ( Site 2236) — Chongqing, Sichuan, China
  • Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2225) — Ürümqi, Xinjiang, China
  • Taizhou Hospital of Zhejiang Province ( Site 2223) — Linhai, Zhejiang, China
  • The First Affiliated Hospital of Wenzhou Medical University ( Site 2235) — Wenzhou, Zhejiang, China
  • Clinique Teissier Groupe ( Site 1006) — Valenciennes, Nord, France
  • Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1108) — Münster, North Rhine-Westphalia, Germany
  • Katholisches Marienkrankenhaus gGmbH ( Site 1101) — Hamburg, Germany
  • ALEXANDRA General Hospital of Athens ( Site 1200) — Athens, Attica, Greece
  • Athens Medical Center ( Site 1201) — Athens, Attica, Greece
  • Metaxa Cancer Hospital of Piraeus ( Site 1203) — Piraeus, Attica, Greece
  • University General Hospital of Alexandroupoli ( Site 1206) — Alexandroupoli, East Macedonia and Thrace, Greece
  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1403) — Meldola, Emilia-Romagna, Italy
  • Istituto Nazionale Tumori Regina Elena ( Site 1404) — Rome, Lazio, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1401) — Rome, Lazio, Italy
  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1400) — Milan, Lombardy, Italy
  • Kobe Minimally Invasive Cancer Center ( Site 2306) — Kobe, Hyōgo, Japan
  • Sendai Kousei Hospital ( Site 2300) — Sendai, Miyagi, Japan
  • Radboudumc ( Site 1504) — Nijmegen, Gelderland, Netherlands
  • Leids Universitair Medisch Centrum ( Site 1503) — Leiden, South Holland, Netherlands
  • University Medical Center Groningen ( Site 1505) — Groningen, Netherlands
  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1602) — Przemyśl, Podkarpackie Voivodeship, Poland
  • National Cancer Center ( Site 2505) — Goyang-si, Kyonggi-do, South Korea
  • Ajou University Hospital ( Site 2504) — Suwon, Kyonggi-do, South Korea
  • Chungbuk National University Hospital ( Site 2502) — Cheongju-si, North Chungcheong, South Korea
  • Keimyung University Dongsan Hospital ( Site 2503) — Daegu, Taegu-Kwangyokshi, South Korea
  • Severance Hospital, Yonsei University Health System ( Site 2501) — Seoul, South Korea
  • Asan Medical Center ( Site 2500) — Seoul, South Korea
  • Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 1807) — Girona, Gerona, Spain
  • Fundación Instituto Valenciano de Oncología ( Site 1809) — Valencia, Valenciana, Comunitat, Spain
  • Hospital Universitari Vall d'Hebron ( Site 1800) — Barcelona, Spain
  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1803) — Madrid, Spain
  • Hospital Clinico San Carlos ( Site 1810) — Madrid, Spain
  • Hospital Universitario La Paz ( Site 1808) — Madrid, Spain
  • Hospital Universitario Virgen Macarena ( Site 1805) — Seville, Spain
  • Taipei Medical University Shuang Ho Hospital ( Site 2612) — New Taipei City, Taiwan
  • National Cheng Kung University Hospital ( Site 2601) — Tainan, Taiwan
  • Mackay Memorial Hospital ( Site 2611) — Taipei, Taiwan
  • National Taiwan University Cancer Center (NTUCC) ( Site 2610) — Taipei, Taiwan
  • Tri-Service General Hospital ( Site 2608) — Taipei, Taiwan
  • Ankara Bilkent Şehir Hastanesi. ( Site 1906) — Çankaya, Ankara, Turkey (Türkiye)
  • KARTAL DR. LÜTF KIRDAR ETM VE ARATIRMA HASTANES. ( Site 1909) — Kartal, Istanbul, Turkey (Türkiye)
  • Adana Medical Park Seyhan Hastanesi ( Site 1910) — Adana, Turkey (Türkiye)
  • Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1903) — Adana, Turkey (Türkiye)
  • Hacettepe Universite Hastaneleri ( Site 1900) — Ankara, Turkey (Türkiye)
  • Liv Hospital Ankara ( Site 1911) — Ankara, Turkey (Türkiye)
  • Erciyes University ( Site 1904) — Kayseri, Turkey (Türkiye)
  • Mersin Sehir Eğitim ve Araştırma Hastanesi. ( Site 1907) — Mersin, Turkey (Türkiye)
  • Recep Tayyip Erdogan University Training and Research Hospital ( Site 1908) — Rize, Turkey (Türkiye)
  • Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 2002) — Chernivtsi, Chernivetska Oblast, Ukraine
  • Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2012) — Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine
  • Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 2006) — Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
  • Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 2013) — Kropyvnytskyi, Kirovohrad Oblast, Ukraine
  • Ukrainian Center of Tomotherapy ( Site 2014) — Kropyvnytskyi, Kirovohrad Oblast, Ukraine
  • Kyiv City Clinical Oncology Center ( Site 2015) — Kyiv, Kyivska Oblast, Ukraine
  • Lviv Oncology Regional Treatment and Diagnostic Center ( Site 2009) — Lviv, Lviv Oblast, Ukraine
  • Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2000) — Lviv, Lviv Oblast, Ukraine
  • Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2011) — Odesa, Odesa Oblast, Ukraine
  • ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2001) — Rivne, Rivne Oblast, Ukraine
  • Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 2004) — Vinnytsia, Vinnytsia Oblast, Ukraine
  • Volyn Regional Clinical Hospital ( Site 2010) — Lutsk, Volyn Oblast, Ukraine
  • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 2005) — Kyiv, Ukraine
  • Shalimov Institute of Surgery and Transplantation ( Site 2003) — Kyiv, Ukraine
  • St James's University Hospital ( Site 2100) — Leeds, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record