Last updated 7 days ago
A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)
310 patients around the world
Available in United States, Argentina
Merck Sharp & Dohme LLC
6Research sites
310Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Sanatorio Parque - Rosario
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
StudyKANDLELIT-015
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07554339
