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

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат Calderasib
  Tablet for oral administration.
• Биопрепарат Durvalumab
  Solution for intravenous (IV) infusion.
• Другое Placebo to MK-1084
  Placebo to MK-1084.

Первичные конечные точки

• Progression-Free Survival (PFS) [Срок оценки: Up to approximately 6 years]

Вторичные конечные точки (9)

• Overall Survival (OS) [Срок оценки: Up to approximately 9 years]
• Number of Participants Who Experience an Adverse Events (AEs) [Срок оценки: Up to approximately 9 years]
• Number of Participants Who Discontinue Study Treatment Due to an AE [Срок оценки: Up to approximately 9 years]
• Objective Response Rate (ORR) [Срок оценки: Up to approximately 9 years]
• Duration of Response (DOR) [Срок оценки: Up to approximately 9 years]
• Distant Metastasis-Free Survival (DMFS) [Срок оценки: Up to approximately 9 years]
• Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Combined Score [Срок оценки: Baseline and up to approximately 9 years]
• Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score [Срок оценки: Baseline and up to approximately 9 years]
• Change from Baseline in Role Functioning (EORTC QLQ-C30 Items 6 & 7) Combined Score [Срок оценки: Baseline and up to approximately 9 years]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Украина · 13 центров

• Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 2002 — Chernivtsi
• Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2012) — Kryvyi Rih
• Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Fra — Ivano-Frankivsk
• Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Si — Kropyvnytskyi
• Ukrainian Center of Tomotherapy ( Site 2014) — Kropyvnytskyi
• Shalimov Institute of Surgery and Transplantation ( Site 2003) — Kyiv
• Lviv Oncology Regional Treatment and Diagnostic Center ( Site 2009) — Lviv
• Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2000) — Lviv
• … и ещё 5 центров

Китай · 10 центров

• Zhongshan Hospital Affiliated to Xiamen University ( Site 2213) — Xiamen
• The First Affiliated Hospital of Xiamen University. ( Site 2239) — Xiamen
• Guangxi Medical University Affiliated Tumor Hospital ( Site 2202) — Qingxiu District
• Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medica — Ухань
• Hubei Cancer Hospital ( Site 2203) — Ухань
• Nanjing Drum Tower Hospital ( Site 2224) — Нанкин
• Shandong Cancer Hospital ( Site 2200) — Цзинань
• Zhongshan Hospital affiliated to Fudan University ( Site 2215) — Шанхай
• … и ещё 2 центра

South Korea · 6 центров

• National Cancer Center ( Site 2505) — Goyang-si
• Ajou University Hospital ( Site 2504) — Suwon
• Chungbuk National University Hospital ( Site 2502) — Cheongju-si
• Keimyung University Dongsan Hospital ( Site 2503) — Daegu
• Severance Hospital, Yonsei University Health System ( Site 2501) — Seoul
• Asan Medical Center ( Site 2500) — Seoul

Испания · 6 центров

• Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 1807) — Girona
• Fundación Instituto Valenciano de Oncología ( Site 1809) — Valencia
• HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1803) — Madrid
• Hospital Clinico San Carlos ( Site 1810) — Madrid
• Hospital Universitario La Paz ( Site 1808) — Madrid
• Hospital Universitario Virgen Macarena ( Site 1805) — Seville

Аргентина · 4 центра

• Clinica Adventista Belgrano ( Site 0304) — Ciudad Autonoma de Buenos Aires
• Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303) — Mar del Plata
• Hospital Britanico de Buenos Aires ( Site 0305) — Buenos Aires
• Sanatorio Parque ( Site 0302) — Rosario

Тайвань · 4 центра

• Taipei Medical University Shuang Ho Hospital ( Site 2612) — New Taipei City
• National Cheng Kung University Hospital ( Site 2601) — Tainan
• Mackay Memorial Hospital ( Site 2611) — Taipei
• Tri-Service General Hospital ( Site 2608) — Taipei

Греция · 3 центра

• Athens Medical Center ( Site 1201) — Athens
• Metaxa Cancer Hospital of Piraeus ( Site 1203) — Piraeus
• University General Hospital of Alexandroupoli ( Site 1206) — Alexandroupoli

Нидерланды · 3 центра

• Radboudumc ( Site 1504) — Nijmegen
• Leids Universitair Medisch Centrum ( Site 1503) — Leiden
• University Medical Center Groningen ( Site 1505) — Groningen

США · 2 центра

• NHO Revive Research Institute LLC ( Site 0118) — Lincoln
• New York Oncology Hematology P.C ( Site 9000) — Albany

Германия · 1 центр

• Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1108) — Münster

Италия · 1 центр

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sac — Rome

Идентификаторы

NCT: NCT07554339 · 1084-015 · 2025-522038-29-00 · U1111-1321-6971 · MK-1084-015 · KANDLELIT-015 · jRCT2021260021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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