ATRA y Atezolizumab para Cáncer de Pulmón No Microcítico Avanzado
Este estudio de fase 1 tiene como objetivo evaluar la seguridad y cualquier efecto secundario de la combinación de ATRA y Atezolizumab en individuos con cáncer de pulmón de células no pequeñas avanzado.
Atezolizumab
+ Tretinoin
Carcinoma de pulmón no microcítico+7
+ Carcinoma broncogénico
+ Neoplasias bronquiales
Estudio de Tratamiento
Resumen
Fecha de inicio: 18 de octubre de 2021
Fecha en la que se inscribió al primer participante.Este estudio se centra en probar una nueva combinación de tratamientos para personas con cáncer de pulmón de células no pequeñas avanzado, un tipo común y grave de cáncer de pulmón. El objetivo principal es determinar si la combinación de dos medicamentos, tretinoína (también conocida como ATRA) y atezolizumab, es segura y bien tolerada por los pacientes. Esto es importante porque encontrar tratamientos efectivos y seguros puede ayudar a mejorar la calidad de vida y las tasas de supervivencia de las personas con este cáncer agresivo. El estudio también evalúa qué tan bien funcionan estos medicamentos juntos para controlar el cáncer y mejorar los resultados de supervivencia. Los participantes en el estudio tomarán tretinoína por vía oral durante los primeros tres días de cada ciclo de tratamiento de 21 días, mientras reciben atezolizumab a través de una infusión intravenosa el primer día de cada ciclo. Los investigadores evaluarán la seguridad del tratamiento monitoreando cualquier efecto secundario experimentado por los participantes. También evaluarán qué tan bien el tratamiento controla el cáncer midiendo factores como la supervivencia sin progresión del cáncer y la supervivencia global. Otro aspecto que se está estudiando es cómo la tretinoína afecta ciertas células inmunitarias en la sangre. A lo largo del estudio, los pacientes serán monitoreados de cerca para cualquier efecto adverso, asegurando su seguridad mientras reciben este tratamiento experimental. Después de completar el tratamiento, los pacientes tendrán controles cada 12 semanas para monitorear su salud.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 18 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Age \>= 18 years * Confirmed recurrent or metastatic non-small cell carcinoma of the lung of any histology for which there is no curative treatment option * Measurable disease based on RECIST 1.1 * Patients must have received standard of care chemotherapy and/or immunotherapy. No limits to prior lines of therapy. Prior PD-1 and/or PD-L1 directed therapies are permitted * Patients with adenocarcinoma and known actionable mutations with FDA-approved treatment options must have received all approved and standard of care treatment options (ie osimertinib for EGFR, alectinib for ALK, etc). Mutational testing is not required for patients with squamous cell non-small cell lung carcinoma * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Absolute neutrophil count (ANC) \>= 1,500/mcL * Lymphocytes ≥500/mcL * Platelets \>=100,000/mcL * Serum creatinine =\< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) \>= 60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN * Serum total bilirubin =\< 1.5 X ULN OR direct bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 ULN * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X ULN OR =\< 5 X ULN for subjects with liver metastases * Albumin \>= 2.5 mg/dL * International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants * Activated partial thromboplastin time (aPTT) =\< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants * Anticipated life expectancy of \>= 3 months * Willing to comply with study procedures * Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication * Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 5 months days after the last dose of study medication. Subjects should agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. Female subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year * Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy. Males must refrain from donating sperm during study participation and for 7 months after the last dose of study medication * Be willing and able to understand and sign the written informed consent document * Ability to swallow and retain oral medication * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible. * History of hepatitis C virus (HCV) infection treated and cured. Exclusion Criteria: * Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment * Has active autoimmune disease, including myasthenic syndrome, which has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment * Cirrhosis (Child-Pugh B or worse) or cirrhosis with history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis * Untreated central nervous system (CNS) metastases. Patients with treated brain metastases are eligible if they were clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) ending at least 2 weeks prior to randomization, or after surgical resection performed at least 28 days prior to randomization. The patient must have no evidence of grade \>= 1 CNS hemorrhage based on pretreatment magnetic resonance imaging (MRI) or IV contrast computed tomography (CT) scan (performed within screening window) * Pregnancy or breastfeeding * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator * Any patient who has experienced an unacceptable toxicity on prior checkpoint inhibitor therapy as detailed below: * \>= grade 3 adverse events (AE) related to checkpoint inhibitor * Ongoing \>= grade 2 immune-related AE associated with checkpoint inhibitor with the exception of endocrine toxicities as detailed below * CNS, ocular or cardiac AE of any grade related to checkpoint inhibitor * NOTE: Patients with a prior or ongoing endocrine AE are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Ohio State University Comprehensive Cancer Center
Columbus, United StatesAbrir Ohio State University Comprehensive Cancer Center en Google Maps