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NCT07554339From ClinicalTrials.govRecruiting

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

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)

  • Non-small Cell Lung Cancer

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
310
Started
18 June 2026
Main results due
15 December 2032
Study sites
84
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(84)

  • NHO Revive Research Institute LLC ( Site 0118)

    Lincoln, Nebraska, United States

    Recruiting

  • New York Oncology Hematology P.C ( Site 9000)

    Albany, New York, United States

    Recruiting

  • WakeMed Raleigh Campus ( Site 0144)

    Raleigh, North Carolina, United States

    Recruiting

  • Virginia Cancer Specialists ( Site 0114)

    Fairfax, Virginia, United States

    Recruiting

  • Instituto Alexander Fleming ( Site 0301)

    Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina

    Recruiting

  • Clinica Adventista Belgrano ( Site 0304)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

    Recruiting

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303)

    Mar del Plata, Buenos Aires, Argentina

    Recruiting

  • Hospital Britanico de Buenos Aires ( Site 0305)

    Buenos Aires, Buenos Aires F.D., Argentina

    Recruiting

  • Sanatorio Parque ( Site 0302)

    Rosario, Santa Fe Province, Argentina

    Recruiting

  • Northern Beaches Hospital ( Site 2401)

    Frenchs Forest, New South Wales, Australia

    Recruiting

  • Princess Alexandra Hospital ( Site 2406)

    Woolloongabba, Queensland, Australia

    Recruiting

  • Frankston Hospital ( Site 2403)

    Frankston, Victoria, Australia

    Recruiting

  • AFECC ASSOCIACAO FEMININA EDUCACAO COMBATE CANCER ( Site 0416)

    Vitória, Espírito Santo, Brazil

    Recruiting

  • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0401)

    Barretos, São Paulo, Brazil

    Recruiting

  • Anhui Provincial Cancer Hospital ( Site 2209)

    Hefei, Anhui, China

    Recruiting

  • Beijing Peking Union Medical College Hospital ( Site 2220)

    Beijing, Beijing Municipality, China

    Recruiting

  • Zhongshan Hospital Affiliated to Xiamen University ( Site 2213)

    Xiamen, Fujian, China

    Recruiting

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

    Xiamen, Fujian, China

    Recruiting

  • Guangxi Medical University Cancer Hospital ( Site 2202)

    Nanning, Guangxi, China

    Recruiting

  • Fourth Hospital of Hebei Medical University ( Site 2201)

    Shijiazhuang, Hebei, China

    Recruiting

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

    Wuhan, Hubei, China

    Recruiting

  • Hubei Cancer Hospital ( Site 2203)

    Wuhan, Hubei, China

    Recruiting

  • The Second Xiangya Hospital Of Central South University ( Site 2207)

    Changsha, Hunan, China

    Recruiting

  • Hunan Cancer Hospital ( Site 2214)

    Changsha, Hunan, China

    Recruiting

  • Nanjing Drum Tower Hospital ( Site 2224)

    Nanjing, Jiangsu, China

    Recruiting

  • Shandong Cancer Hospital ( Site 2200)

    Jinan, Shandong, China

    Recruiting

  • Zhongshan Hospital affiliated to Fudan University ( Site 2215)

    Shanghai, Shanghai Municipality, China

    Recruiting

  • Fudan University Shanghai Cancer Center ( Site 2216)

    Shanghai, Shanghai Municipality, China

    Recruiting

  • Shanxi Provincial Cancer Hospital ( Site 2227)

    Taiyuan, Shanxi, China

    Recruiting

  • Sichuan Cancer hospital. ( Site 2218)

    Chengdu, Sichuan, China

    Recruiting

  • Taizhou Hospital of Zhejiang Province ( Site 2223)

    Linhai, Zhejiang, China

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University ( Site 2235)

    Wenzhou, Zhejiang, China

    Recruiting

  • Clinique Teissier Groupe ( Site 1006)

    Valenciennes, Nord, France

    Recruiting

  • Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1108)

    Münster, North Rhine-Westphalia, Germany

    Recruiting

  • ALEXANDRA General Hospital of Athens ( Site 1200)

    Athens, Attica, Greece

    Recruiting

  • Athens Medical Center ( Site 1201)

    Athens, Attica, Greece

    Recruiting

  • Metaxa Cancer Hospital of Piraeus ( Site 1203)

    Piraeus, Attica, Greece

    Recruiting

  • University General Hospital of Alexandroupoli ( Site 1206)

    Alexandroupoli, East Macedonia and Thrace, Greece

    Recruiting

  • Istituto Nazionale Tumori Regina Elena ( Site 1404)

    Rome, Lazio, Italy

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1401)

    Rome, Lazio, Italy

    Recruiting

  • Sendai Kousei Hospital ( Site 2300)

    Sendai, Miyagi, Japan

    Recruiting

  • Radboudumc ( Site 1504)

    Nijmegen, Gelderland, Netherlands

    Recruiting

  • Leids Universitair Medisch Centrum ( Site 1503)

    Leiden, South Holland, Netherlands

    Recruiting

  • University Medical Center Groningen ( Site 1505)

    Groningen, Netherlands

    Recruiting

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1602)

    Przemyśl, Podkarpackie Voivodeship, Poland

    Recruiting

  • National Cancer Center ( Site 2505)

    Goyang-si, Kyonggi-do, South Korea

    Recruiting

  • Ajou University Hospital ( Site 2504)

    Suwon, Kyonggi-do, South Korea

    Recruiting

  • Chungbuk National University Hospital ( Site 2502)

    Cheongju-si, North Chungcheong, South Korea

    Recruiting

  • Keimyung University Dongsan Hospital ( Site 2503)

    Daegu, Taegu-Kwangyokshi, South Korea

    Recruiting

  • Severance Hospital, Yonsei University Health System ( Site 2501)

    Seoul, South Korea

    Recruiting

  • Asan Medical Center ( Site 2500)

    Seoul, South Korea

    Recruiting

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

    Girona, Gerona, Spain

    Recruiting

  • Fundación Instituto Valenciano de Oncología ( Site 1809)

    Valencia, Valenciana, Comunitat, Spain

    Recruiting

  • Hospital Universitari Vall d'Hebron ( Site 1800)

    Barcelona, Spain

    Recruiting

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1803)

    Madrid, Spain

    Recruiting

  • Hospital Clinico San Carlos ( Site 1810)

    Madrid, Spain

    Recruiting

  • Hospital Universitario La Paz ( Site 1808)

    Madrid, Spain

    Recruiting

  • Hospital Universitario Virgen Macarena ( Site 1805)

    Seville, Spain

    Recruiting

  • Taipei Medical University Shuang Ho Hospital ( Site 2612)

    New Taipei City, Taiwan

    Recruiting

  • National Cheng Kung University Hospital ( Site 2601)

    Tainan, Taiwan

    Recruiting

Showing 60 of 84 sites — filter to narrow it down. 84 of the 84 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07554339. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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