A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC (AmiNA)
A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination With Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer
The purpose of this study is to assess the ability to slow down or stop the growth of cancer with amivantamab combined with either lazertinib or chemotherapy (carboplatin and pemetrexed) in participants with resectable, epidermal growth factor receptor (EGFR) mutated, Stage II-IIIB non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer. NSCLC may occur due to mutations (changes) in many genes, including EGFR.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Study Contact
- Número de teléfono: 844-434-4210
- Correo electrónico: Participate-In-This-Study1@its.jnj.com
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M5G 2C1
- Reclutamiento
- Princess Margaret Hospital
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Buk Gu, Corea del Sur, 41404
- Reclutamiento
- Kyungpook National University Chilgok Hospital
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Busan, Corea del Sur, 49241
- Reclutamiento
- Pusan National University Hospital
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Seoul, Corea del Sur, 06351
- Reclutamiento
- Samsung Medical Center
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Seoul, Corea del Sur, 03722
- Reclutamiento
- Severance Hospital Yonsei University Health System
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Seoul, Corea del Sur, 152-703
- Reclutamiento
- Korea University Guro Hospital
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Alicante, España, 03010
- Reclutamiento
- Hosp. Gral. Univ. Dr. Balmis
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Barcelona, España, 8035
- Reclutamiento
- Hosp Univ Vall D Hebron
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Madrid, España, 28007
- Reclutamiento
- Hosp. Gral. Univ. Gregorio Maranon
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California
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Duarte, California, Estados Unidos, 91010
- Reclutamiento
- City of Hope
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Irvine, California, Estados Unidos, 92618
- Reclutamiento
- City of Hope 1
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Stanford, California, Estados Unidos, 94305
- Reclutamiento
- Stanford Cancer Institute
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Oregon
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Portland, Oregon, Estados Unidos, 97213
- Reclutamiento
- Providence Cancer Center
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Portland, Oregon, Estados Unidos, 97225
- Reclutamiento
- Providence Oncology and Hematology Care Clinic Westside
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Virginia
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Fairfax, Virginia, Estados Unidos, 22031
- Reclutamiento
- Virginia Cancer Specialists
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Beijing, Porcelana, 100142
- Reclutamiento
- Beijing Cancer Hospital of Peking University
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Cheng Du Shi, Porcelana, 610044
- Reclutamiento
- Sichuan Cancer Hospital
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Chengdu, Porcelana, 610041
- Reclutamiento
- West China Hospital Sichuan University
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Guangzhou, Porcelana, 510060
- Reclutamiento
- Guangdong Provincial People's Hospital
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Jinan, Porcelana, 250117
- Reclutamiento
- Shandong Cancer Hospital
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Shanghai, Porcelana, 200433
- Reclutamiento
- Shanghai Pulmonary Hospital
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Tianjin, Porcelana, 300222
- Reclutamiento
- Tianjin Chest Hospital
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Taichung, Taiwán, 40705
- Reclutamiento
- Taichung Veterans General Hospital
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Tainan, Taiwán, 736
- Reclutamiento
- Chi Mei Medical Center Liouying Branch
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Taipei, Taiwán, 10048
- Reclutamiento
- National Taiwan University Hospital
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Taipei, Taiwán, 110
- Reclutamiento
- Taipei Medical University Hospital
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Zhubei, Taiwán, 302
- Reclutamiento
- NTU Biomedical Park Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Participant must have histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) with completely resectable Stage II-IIIB N2 disease
- Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a multidisciplinary team evaluation
- Participant must consent to a screening biopsy, if clinically feasible, if no adequate tumor tissue is available for a baseline sample
- Participant may have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s). Prior or concurrent second malignancies must be reviewed and agreed to with the medical monitor
- Have an eastern cooperative oncology group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- History of uncontrolled illness
- Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current interstitial lung disease (ILD)/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
- Suspected or known allergies, hypersensitivity, or intolerance to excipients of: the combination of amivantamab and lazertinib or carboplatin and pemetrexed
- Presence of primary driver mutations (anaplastic lymphoma kinase [ALK], mesenchymal-epithelial transition [MET], human epidermal growth factor receptor 2 [HER2], proto-oncogene tyrosine-protein kinase ROS [ROS1], neurotrophic tyrosine receptor kinase [NTRK], B-Raf proto-oncogene [BRAF], REarranged during transfection [RET], or kirsten rat sarcoma viral oncogene homolog [KRAS]) , besides EGFR Exon 19del or Exon 21 L858R mutations, as determined by local genomic testing
- Prior treatment with any systemic anti-cancer therapy for NSCLC including EGFR-tyrosine kinase inhibitor (TKI) therapy, chemotherapy, biologic therapy, immunotherapy, or any investigational drug
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Cohort 1: Amivantamab plus Lazertinib
Participants will receive amivantamab in combination with lazertinib. |
Amivantamab will be administered.
Otros nombres:
Lazertinib will be administered.
Otros nombres:
|
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Experimental: Cohort 2: Amivantamab plus Carboplatin and Pemetrexed
Participants will receive amivantamab in combination with carboplatin and pemetrexed. |
Amivantamab will be administered.
Otros nombres:
Carboplatin will be administered. Pemetrexed will be administered. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Major Pathologic response (MPR)
Periodo de tiempo: Up to 1 year 8 months
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MPR is defined as less than or equal to (<= ) 10 percent (%) residual cancer cells in the surgical specimen, per independent centralized pathology review. |
Up to 1 year 8 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pathological Complete Response (pCR)
Periodo de tiempo: Up to 1 year 8 months
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pCR is defined as absence of any residual cancer cells in the surgical specimen, per independent centralized pathology review. |
Up to 1 year 8 months
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Number of Participants with Pathologic Nodal Downstaging at the Time of Surgery
Periodo de tiempo: Baseline and up to 1 year 8 months
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Pathologic nodal downstaging is defined as baseline N2 participants becoming N1/node negative N0 or baseline N1 patients becoming N0 at the time of surgery. |
Baseline and up to 1 year 8 months
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Disease Control Rate (DCR)
Periodo de tiempo: Up to 1 year 8 months
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DCR is defined as the percentage of participants who achieve a radiologic best overall response (BOR) of partial response (PR), complete response (CR), or stable disease (SD) using response evaluation criteria in solid tumors (RECIST) version 1.1. |
Up to 1 year 8 months
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Number of Participants with Adverse Events (AEs) by Severity
Periodo de tiempo: Up to 1 year 8 months
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An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy, whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy or any AE that is considered treatment-related regardless of the start date of the event is considered to be treatment-emergent. TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, to Grade 5= death related to adverse event. |
Up to 1 year 8 months
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Number of Participants with Abnormalities in Clinical Laboratory Parameters
Periodo de tiempo: Up to 1 year 8 months
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Number of participants with abnormalities in clinical laboratory parameters (which includes hematology, coagulation, clinical chemistry, routine urinalysis, serology and pregnancy test) will be reported. |
Up to 1 year 8 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Neoplasias Pulmonares
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Carcinoma de pulmón de células no pequeñas
- Aminoácidos, péptidos y proteínas
- Químicos orgánicos
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Complejos de coordinación
- Guanina
- Hipoxantino
- Purinones
- Purinas
- Glutamatos
- Aminoácidos, ácido
- Aminoácidos
- Aminoácidos, dicarboxílico
- Pemetrexed
- Carboplatino
- amivantamab
- lazertinib
Otros números de identificación del estudio
- 61186372PANSC2005
- 61186372PANSC2005 (Otro identificador: Janssen Research & Development, LLC)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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