A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)

Официальное название

A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)

Обзор

Researchers are looking for new ways to treat high-risk, localized non-small cell lung cancer (NSCLC) that has been removed with surgery. People with high-risk, localized NSCLC are often treated with surgery. Researchers want to learn if participants can receive 1 or 2 trial treatments to help prevent NSCLC from coming back after surgery. One trial medicine is intismeran (also called V940/mRNA-4157) and the other is subcutaneous pembrolizumab (also called SC pembrolizumab and MK-3475A). Intismeran is designed to help a person's immune system attack their specific cancer. SC pembrolizumab is an immunotherapy treatment which helps the immune system fight cancer. The main purpose of this study is to evaluate whether adjuvant intismeran autogene (V940) in combination with SC pembrolizumab and berahyaluronidase alfa (MK-3475A) or intismeran monotherapy improves disease-free survival (DFS) compared with placebo in participants with completely resected high-risk Stage I NSCLC.

Вмешательства

• Биопрепарат Intismeran
  IM injection
• Биопрепарат Pembrolizumab coformulated with berahyaluronidase alfa
  SC injection
• Другое Placebo
  IM injection

Первичные конечные точки

• Disease-Free Survival (DFS) as Assessed by Blinded Independent Central Review (BICR) in Participants With Nonsquamous Non-Small Cell Lung Cancer (NSCLC) in Arm A and Arm C [Срок оценки: Up to approximately 98 months]

Вторичные конечные точки (8)

• DFS as Assessed by BICR [Срок оценки: Up to approximately 98 months]
• Distant Metastasis-Free Survival (DMFS) [Срок оценки: Up to approximately 111 months]
• Overall Survival (OS) [Срок оценки: Up to approximately 123 months]
• Number Participants Who Experience an Adverse Events (AE) [Срок оценки: Up to approximately 144 months]
• Number of Participants Who Discontinue Study Treatment Due to an AE [Срок оценки: Up to approximately 144 months]
• Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score [Срок оценки: Baseline and up to approximately 36 months]
• Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score [Срок оценки: Baseline and up to approximately 36 months]
• Change From Baseline in Role Functioning (EORTC QLQ-C30 Items 6-7) Score [Срок оценки: Baseline and up to approximately 36 months]

Критерии участия

Критерии включения

The main inclusion criteria include but are not limited to the following:

• Has a histological diagnosis of pathological Stage I (tumor ≤4 cm) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) 9th Edition with at least 1of the following high-risk pathologic features as assessed locally: tumor size >2cm, visceral pleural invasion, lymphovascular invasion, or high-grade histology
• Has undergone a complete surgical resection of the primary NSCLC
• Has not received other prior treatment outside of definitive surgery (including but not limited to chemotherapy, immunotherapy, targeted therapy, or radiotherapy) for their current Stage I NSCLC
• Has provided a tissue sample from recent surgery along with the required blood sample
• Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
• Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization
• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Критерии исключения

The main exclusion criteria include but are not limited to the following:

• Has diagnosis of any 1 of the following: small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or two synchronous primary NSCLCs
• Has any clinically significant cardiovascular disease within 12 months before randomization, including a history of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), valvular heart disease requiring surgical intervention, New York Heart Association Class III-IV heart failure, unstable angina, myocardial infarction (MI), pulmonary hypertension, cardiovascular accident (CVA), or hemodynamically unstable cardiac arrhythmia
• HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• Has known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
• Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has active infection requiring systemic therapy other than those permitted in protocol
• Has history of stem cell/solid organ transplant
• Participants who have not adequately recovered from major surgery or have 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

США · 9 центров

• Smilow Cancer Center at Yale-New Haven ( Site 3253) — New Haven
• Billings Clinic ( Site 3255) — Billings
• NHO Revive Research Institute, LLC ( Site 3218) — Lincoln
• Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207) — Reno
• White Plains Hospital ( Site 3213) — White Plains
• WakeMed Raleigh Campus ( Site 3214) — Raleigh
• Altru Health System ( Site 3254) — Grand Forks
• The University of Tennessee Medical Center ( Site 3223) — Knoxville
• … и ещё 1 центр

Израиль · 5 центров

• Rambam Health Care Campus ( Site 3303) — Haifa
• Shaare Zedek Medical Center ( Site 3301) — Jerusalem
• Hadassah Medical Center ( Site 3305) — Jerusalem
• Meir medical center ( Site 3306) — Kfar Saba
• Sheba Medical Center ( Site 3302) — Ramat Gan

Нидерланды · 5 центров

• Ziekenhuis St. Jansdal ( Site 4800) — Harderwijk
• Radboudumc ( Site 4806) — Nijmegen
• Frisius Medisch Centrum ( Site 4808) — Leeuwarden
• Meander Medisch Centrum ( Site 4802) — Amersfoort
• University Medical Center Groningen ( Site 4807) — Groningen

Тайвань · 5 центров

• Chang Gung Memorial Hospital at Kaohsiung ( Site 5302) — Kaohsiung City
• China Medical University Hospital ( Site 5303) — Taichung
• Taichung Veterans General Hospital ( Site 5301) — Taichung
• National Cheng Kung University Hospital ( Site 5300) — Tainan
• Taipei Medical University Hospital ( Site 5305) — Taipei

Венгрия · 4 центра

• Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 4401) — Pécs
• Borsod-Abaúj-Zemplén Vármegyei Központi Kórház És Egyetemi Oktatókórház ( Site 4409) — Miskolc
• Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 4406) — Kecskemét
• Országos Onkológiai Intézet ( Site 4405) — Budapest

Испания · 4 центра

• Hospital de Cruces ( Site 0308) — Barakaldo
• HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 0307) — Madrid
• Hospital Clinico San Carlos ( Site 0303) — Madrid
• Hospital Universitario Virgen Macarena ( Site 0306) — Seville

Канада · 3 центра

• Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506) — Hamilton
• Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503) — Kingston
• Centre Hospitalier de l'Université de Montréal ( Site 2501) — Montreal

Польша · 3 центра

• Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 4202) — Poznan
• IP Clinic ( Site 4204) — Lodz
• Wojewodzki Szpital Specjalistyczny im. sw. Rafala w Czerwonej Gorze ( Site 4206) — Chęciny

Австралия · 2 центра

• Royal North Shore Hospital ( Site 0502) — St Leonards
• One Clinical Research ( Site 0501) — Nedlands

Греция · 2 центра

• Errikos Dunant Hospital Center ( Site 5004) — Athens
• European Interbalkan Medical Center-Oncology Department ( Site 5000) — Thessaloniki

Turkey (Türkiye) · 2 центра

• Hacettepe Universite Hastaneleri-oncology hospital ( Site 4300) — Ankara
• İstinye Üniversitesi Liv Hospital-Topkapi ( Site 4307) — Istanbul

Германия · 1 центр

• Augusta-Kranken-Anstalt ( Site 2702) — Bochum

Италия · 1 центр

• Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2803) — Novara

Идентификаторы

NCT: NCT07513376 · V940-014 · V940-014 · U1111-1323-9950 · 2025-522643-18-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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