Resumen

El cáncer es una enfermedad en la que las células de una parte específica del organismo crecen y se reproducen de manera descontrolada. El cáncer de pulmón no microcítico (CPNM) es un tumor sólido, una enfermedad en la que células cancerosas se forman en los tejidos del pulmón. El propósito de este estudio es determinar si telisotuzumab vedotina es superior a docetaxel y evaluar la seguridad de telisotuzumab vedotina en participantes adultos con CPNM previamente tratados. Se evaluarán los cambios en la actividad de la enfermedad y los eventos adversos. Telisotuzumab vedotina es un fármaco en investigación en desarrollo para el tratamiento del CPNM. Los participantes serán asignados aleatoriamente a un tratamiento con Teliso-V o Docetax en una proporción 1:1. Cada grupo recibirá una infusión intravenosa (IV) de telisotuzumab vedotina o una infusión IV de docetaxel. Aproximadamente 698 participantes adultos con CPNM con sobreexpresión de c-Met serán inscritos en el estudio en aproximadamente 330 centros de todo el mundo. Los participantes recibirán telisotuzumab vedotina IV cada 2 semanas o docetaxel cada 3 semanas hasta cumplir los criterios de discontinuación del fármaco del estudio. Al concluir el estudio, los participantes que continúen mostrando beneficio clínico podrán ser elegibles para recibir el tratamiento del estudio a través de una extensión del mismo, un estudio de incorporación u otro mecanismo. Puede haber una mayor carga de tratamiento para los participantes en este ensayo en comparación con su atención estándar. Los participantes asistirán a visitas regulares durante el estudio en un hospital o clínica. El efecto del tratamiento será verificado mediante evaluaciones médicas, análisis de sangre, monitoreo de efectos secundarios y la cumplimentación de cuestionarios.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Projected life expectancy of at least 12 weeks.
Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.
Archival or fresh tumor material must be submitted for assessment of c-Met protein expression levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.
If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).
A histologically or cytologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
A known epidermal growth factor receptor (EGFR) activating mutation status.
\-- Participants with actionable EGFR activating mutations are not eligible
Actionable alterations in genes other than EGFR are eligible.
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy.
Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC:
Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase \[ALK\] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.
Participants with actionable gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
Participants with metastases to the central nervous system (CNS) are eligible only after adequate treatment (such as surgery, radiotherapy, or drug therapy) is provided and:
They are asymptomatic and off or on a stable or reducing dose of systemic steroids (on no more than 10 mg per day \[QD\] prednisone or equivalent) and/or anticonvulsants for at least 2 weeks prior to randomization.

Criterios de exclusión

Evidence of new, untreated CNS metastases or progressing CNS metastases after treatment.
Evidence of leptomeningeal disease.
Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.
Epidermal growth factor receptor (EGFR) activating mutations.
Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..
Participants who have received prior docetaxel therapy.
A history of other malignancies except:
Malignancy treated with curative intent and with no known active disease present for \>=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator. Additionally, participants must not be receiving any ongoing anti-cancer therapy, including maintenance therapy, prior to randomization..
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
Adequately treated carcinoma in situ without current evidence of disease.
A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. A history of prior radiation pneumonitis in the radiation field (fibrosis) is not permitted.
Unresolved or neuroendocrine histology, nor sarcomatoid features adverse event (AE) \>= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.
Major surgery within 21 days prior to randomization.
Clinically significant condition(s) as listed in the protocol.

Ubicaciones

Cemic /Id# 231486

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

RECRUITING

Hospital Britanico de Buenos Aires /ID# 231495

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

RECRUITING

Centro Médico Austral /ID# 239860

Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina

RECRUITING

Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339

Viedma, Río Negro Province, Argentina

RECRUITING

LC Investigacion /ID# 239880

Buenos Aires, Argentina

RECRUITING

Instituto de Oncología Angel H. Roffo /ID# 231499

Buenos Aires, Argentina

Site Coordinator · 5491141689984

RECRUITING

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Telisotuzumab Vedotin

Docetaxel

Ubicaciones

Cemic /Id# 231486

Hospital Britanico de Buenos Aires /ID# 231495

Centro Médico Austral /ID# 239860

Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339

LC Investigacion /ID# 239880

Instituto de Oncología Angel H. Roffo /ID# 231499

Patrocinadores

Contactos

ABBVIE CALL CENTER