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)
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase III
PATOLOGÍA
Terapia celular y T-CARs, Trombosis y Anticoagulantes, Linfoma
CENTRO INVESTIGADOR
H.G.U. Gregorio Marañón
INVESTIGADOR PRINCIPAL
Antonio Calles Blanco
CENTRO INVESTIGADOR
H.U. Clínico San Carlos
INVESTIGADOR PRINCIPAL
Carlos Aguado de la Rosa
FECHA DE APERTURA
Junio, 2026
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
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
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
CRITERIOS DE EXCLUSIÓN
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 Kaposis sarcoma and/or Multicentric Castlemans 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
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 Kaposis sarcoma and/or Multicentric Castlemans 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
DESCRIPCIÓN
1. To compare intismeran in combination with MK-3475A to placebo with respect to DFS assessed by BICR in nonsquamous NSCLC.
PALABRAS CLAVE
antagonistas de la vitamin k, gene therapy, vitamin k antagonist
