A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)

Официальное название

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)

Обзор

Researchers want to know if intismeran autogene (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). Intismeran autogene is designed to help a person's immune system attack their specific cancer. The goal of this study is to learn if people who receive intismeran autogene with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of the study treatment.

Вмешательства

• Биопрепарат Intismeran Autogene
  1 mg Intramuscular (IM) Injection
• Биопрепарат Pembrolizumab
  200 mg IV Infusion
• Препарат Carboplatin
  Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion
• Препарат Paclitaxel
  200 or 175 mg/m\^2 IV Infusion
• Препарат Nab-paclitaxel
  100 mg/m\^2 IV Infusion
• Другое Placebo
  Placebo matched to Intismeran Autogene IM injection

Первичные конечные точки

• Progression Free Survival (PFS) [Срок оценки: Up to ~32 months]
• Overall Survival (OS) [Срок оценки: Up to ~42 months]

Вторичные конечные точки (4)

• Overall Response Rate (ORR) [Срок оценки: Up to ~26 months]
• Duration of Response (DOR) [Срок оценки: Up to ~42 months]
• Number of Participants who Experience an Adverse Event (AE) [Срок оценки: Up to ~42 months]
• Number of Participants who Discontinue Study Intervention Due to an AE [Срок оценки: Up to ~24 months]

Критерии участия

Критерии включения

Inclusion Criteria include, but are not limited to:

• Has a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c1, M1c2, AJCC Staging Manual, Version 9). NOTE: Mixed tumors will be characterized by the predominant cell type; however, small cell elements are not permitted.
• Has measurable disease per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology
• Has provided a tissue sample that is collected either at the time of or after the diagnosis of metastatic disease AND is from a site not previously irradiated
• Adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
• Hepatitis B surface antigen (HBsAg) positive participants 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. NOTE: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
• Has a life expectancy of at least 3 months
• Has adequate organ function

Критерии исключения

Exclusion Criteria include, but are not limited to:

• Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• Has received prior treatment with a cancer vaccine, including another personalized cancer vaccine (PCV)
• Has received prior systemic anticancer therapy for their metastatic NSCLC
• Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor. NOTE: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
• Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
• Has received radiation therapy to the lung that is >30 gray within 6 months of start of study intervention
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
• Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
• Has known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has severe hypersensitivity (≥Grade 3) to V940, pembrolizumab, or any of the protocol allowed chemotherapy agents and/or any of their excipients
• Has active autoimmune disease that has required systemic treatment in the past 2 years
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has 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

США · 10 центров

• Moffitt Cancer Center ( Site 0021) — Tampa
• Washington University School of Medicine ( Site 0024) — St Louis
• Valley Health Systems - Ridgewood Campus ( Site 0010) — Paramus
• New York Oncology Hematology (NYOH) - Albany Medical Center ( Site 9001) — Albany
• Cleveland Clinic - Ohio ( Site 0016) — Cleveland
• Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 002 — Corvallis
• Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000) — Nashville
• Texas Oncology - Central/South Texas ( Site 8002) — Austin
• … и ещё 2 центра

Аргентина · 6 центров

• Hospital Italiano de Buenos Aires ( Site 0200) — Ciudad Autonoma de Buenos Aires.
• Instituto Alexander Fleming ( Site 0201) — Ciudad Autonoma de Buenos Aires
• Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205) — Mar del Plata
• Clinica Adventista Belgrano ( Site 0206) — Caba.
• Fundacion Estudios Clinicos ( Site 0207) — Rosario
• Sanatorio Parque ( Site 0203) — Rosario

Испания · 6 центров

• ICO L Hospitalet ( Site 1311) — Hospitalet
• Hospital Jerez de la Frontera-UGC Oncología ( Site 1315) — Jerez de la Frontera
• Hospital Universitari Vall d''Hebron ( Site 1310) — Barcelona
• Hospital Ramon y Cajal ( Site 1314) — Madrid
• Hospital Clinico San Carlos... ( Site 1313) — Madrid
• Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1312) — Seville

Тайвань · 6 центров

• China Medical University Hospital ( Site 0606) — Taichung
• National Cheng Kung University Hospital ( Site 0601) — Tainan
• Mackay Memorial Hospital ( Site 0604) — Taipei
• National Taiwan University Cancer Center (NTUCC) ( Site 0600) — Taipei
• Taipei Veterans General Hospital ( Site 0602) — Taipei
• Chang Gung Medical Foundation-Linkou Branch ( Site 0605) — Taoyuan

South Korea · 5 центров

• National Cancer Center ( Site 0504) — Goyang-si
• Seoul National University Bundang Hospital ( Site 0500) — Seongnam-si
• Chungbuk National University Hospital-Internal medicine ( Site 0501) — Cheongju-si
• Asan Medical Center ( Site 0503) — Seoul
• Samsung Medical Center ( Site 0502) — Seoul

Чили · 4 центра

• Centro de Estudios Clínicos SAGA ( Site 0307) — Santiago
• FALP ( Site 0300) — Santiago
• Bradfordhill ( Site 0301) — Santiago
• Bradford Hill Norte ( Site 0308) — Antofagasta

Италия · 4 центра

• Ospedale Santa Maria delle Croci-Dipartimento Oncoematologico ( Site 1004) — Ravenna
• Ospedale San Raffaele-Oncologia Medica ( Site 1002) — Milan
• Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 1000) — Milan
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sac — Roma

Turkey (Türkiye) · 4 центра

• Hacettepe Universitesi Tıp Fakultesi ( Site 1400) — Ankara
• Memorial Ankara Hastanesi ( Site 1401) — Ankara
• Ankara Bilkent Şehir Hastanesi ( Site 1402) — Ankara
• Koç Üniversitesi Hastanesi ( Site 1403) — Istanbul

Австралия · 3 центра

• Westmead Hospital ( Site 0400) — Westmead
• Princess Alexandra Hospital ( Site 0403) — Woolloongabba
• One Clinical Research ( Site 0402) — Nedlands

Франция · 3 центра

• Centre Georges François Leclerc ( Site 0805) — Dijon
• Institut de Cancérologie de l'Ouest ( Site 0801) — Angers
• CHU GABRIEL MONTPIED ( Site 0802) — Clermont-Ferrand

Польша · 3 центра

• Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1101) — Poznan
• Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w W — Warsaw
• Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1102) — Przemyśl

Идентификаторы

NCT: NCT07221474 · V940-013 · V940-013 · U1111-1318-2495 · 2025-520902-37-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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