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Clinical Trials in the USA / NCT07554339
Recruiting Phase 3

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

NCT07554339 · tracked via the Priya Life Science USA tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2026-06-18
Last updated
2026-09-14

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

CalderasibDurvalumabPlacebo to MK-1084

Calderasib: Tablet for oral administration.

Durvalumab: Solution for intravenous (IV) infusion.

Placebo to MK-1084: Placebo to MK-1084.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (73)

FacilityCityRegionStatus
NHO Revive Research Institute LLC ( Site 0118) Lincoln Nebraska Recruiting
New York Oncology Hematology P.C ( Site 9000) Albany New York Recruiting
WakeMed Raleigh Campus ( Site 0144) Raleigh North Carolina Recruiting
Instituto Alexander Fleming ( Site 0301) Ciudad Autonoma de Buenos Aires. Buenos Aires Recruiting
Clinica Adventista Belgrano ( Site 0304) Ciudad Autonoma de Buenos Aires Buenos Aires Recruiting
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303) Mar del Plata Buenos Aires Recruiting
Hospital Britanico de Buenos Aires ( Site 0305) Buenos Aires Buenos Aires F.D. Recruiting
Sanatorio Parque ( Site 0302) Rosario Santa Fe Province Recruiting
Northern Beaches Hospital ( Site 2401) Frenchs Forest New South Wales Recruiting
Princess Alexandra Hospital ( Site 2406) Woolloongabba Queensland Recruiting
AFECC ASSOCIACAO FEMININA EDUCACAO COMBATE CANCER ( Site 0416) Vitória Espírito Santo Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0401) Barretos São Paulo Recruiting
Anhui Provincial Cancer Hospital ( Site 2209) Hefei Anhui Recruiting
Beijing Peking Union Medical College Hospital ( Site 2220) Beijing Beijing Municipality Recruiting
Zhongshan Hospital Affiliated to Xiamen University ( Site 2213) Xiamen Fujian Recruiting
The First Affiliated Hospital of Xiamen University. ( Site 2239) Xiamen Fujian Recruiting
Guangxi Medical University Cancer Hospital ( Site 2202) Nanning Guangxi Recruiting
Fourth Hospital of Hebei Medical University ( Site 2201) Shijiazhuang Hebei Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2206) Wuhan Hubei Recruiting
Hubei Cancer Hospital ( Site 2203) Wuhan Hubei Recruiting
The Second Xiangya Hospital Of Central South University ( Site 2207) Changsha Hunan Recruiting
Nanjing Drum Tower Hospital ( Site 2224) Nanjing Jiangsu Recruiting
Shandong Cancer Hospital ( Site 2200) Jinan Shandong Recruiting
Zhongshan Hospital affiliated to Fudan University ( Site 2215) Shanghai Shanghai Municipality Recruiting
Fudan University Shanghai Cancer Center ( Site 2216) Shanghai Shanghai Municipality Recruiting
Shanxi Provincial Cancer Hospital ( Site 2227) Taiyuan Shanxi Recruiting
Sichuan Cancer hospital. ( Site 2218) Chengdu Sichuan Recruiting
Taizhou Hospital of Zhejiang Province ( Site 2223) Linhai Zhejiang Recruiting
Clinique Teissier Groupe ( Site 1006) Valenciennes Nord Recruiting
Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1108) Münster North Rhine-Westphalia Recruiting
ALEXANDRA General Hospital of Athens ( Site 1200) Athens Attica Recruiting
Athens Medical Center ( Site 1201) Athens Attica Recruiting
Metaxa Cancer Hospital of Piraeus ( Site 1203) Piraeus Attica Recruiting
University General Hospital of Alexandroupoli ( Site 1206) Alexandroupoli East Macedonia and Thrace Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1401) Rome Lazio Recruiting
Sendai Kousei Hospital ( Site 2300) Sendai Miyagi Recruiting
Radboudumc ( Site 1504) Nijmegen Gelderland Recruiting
Leids Universitair Medisch Centrum ( Site 1503) Leiden South Holland Recruiting
University Medical Center Groningen ( Site 1505) Groningen Netherlands Recruiting
National Cancer Center ( Site 2505) Goyang-si Kyonggi-do Recruiting

+ 33 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07554339 on ClinicalTrials.gov ↗ ← All trials in the USA