Resumen

Este ensayo clínico estudia el cáncer de pulmón de células no pequeñas (CPNP) no escamoso. Los participantes de este estudio deben tener un cáncer que se haya diseminado por su cuerpo o que no pueda extirparse mediante cirugía. Los participantes de este estudio deben haber recibido, como máximo, una quimioterapia basada en platino y un fármaco anti-PD-(L)1. Los participantes con tumores que presenten ciertas alteraciones genómicas tratables deben haber recibido al menos 1 fármaco dirigido a dicha alteración genómica, además de la quimioterapia basada en platino. Este ensayo clínico utiliza un fármaco en investigación denominado sigvotatug vedotin, que es un tipo de conjugado anticuerpo-fármaco o ADC. Los ADC están diseñados para adherirse a las células cancerosas y destruirlas. Este ensayo clínico también utiliza un fármaco denominado docetaxel. El docetaxel es un fármaco anticancerígeno aprobado para tratar el cáncer de pulmón de células no pequeñas. Generalmente se administra a pacientes que han recibido previamente otro tratamiento anticancerígeno. En este estudio, un grupo de participantes recibirá sigvotatug vedotin los días 1 y 15 de cada ciclo de 28 días. Un segundo grupo de participantes recibirá docetaxel el día 1 de cada ciclo de 21 días. Este estudio se realiza para determinar si sigvotatug vedotin funciona mejor que docetaxel en el tratamiento de participantes con CPNP. También se evaluarán los efectos secundarios que se producen cuando los participantes toman estos fármacos. Un efecto secundario es cualquier efecto que un fármaco produce en el organismo, además de tratar la enfermedad.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically or cytologically confirmed diagnosis of locally advanced, unresectable (Stage IIIB, IIIC), or metastatic Stage IV (M1a, M1b, or M1c) NSCLC American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer Control (UICC) Staging System (Eighth edition).
Participants must have NSCLC with nonsquamous histology
Tumors with squamous, or predominantly squamous histology are excluded.
Tumors with small cell elements are excluded.
Participants who have NSCLC with known actionable genomic alteration (AGAs) are permitted
Participants must have received the following prior therapies and progressed during or relapsed after receiving their most recent prior therapy:
Participants with no known AGAs must fulfill 1 of the following conditions:
Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease and a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy), unless contraindicated.
Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant or neoadjuvant setting and received a PD-(L)1 monoclonal antibody at any time during the course of treatment.
Participants with known AGAs must fulfill the following conditions:
Must have received at least 1 relevant AGA targeted therapy and in the opinion of the investigator, additional AGA targeted therapy is not in the best interest of the participant.
Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant or neoadjuvant setting
May have received up to 1 PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
Measurable disease based on RECIST v1.1
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with adequate baseline hematologic, hepatic, and renal function and measurable disease according to RECIST v1.1

Criterios de exclusión

Life expectancy of less than (\<) 3 months
Known allergies/hypersensitivity/intolerance to or contraindication of taxanes, docetaxel, or any excipient contained in the drug formulation of sigvotatug vedotin
History of another malignancy within 3 years before Cycle 1 Day 1, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death
Participants with any of the following respiratory conditions:
Evidence of noninfectious interstitial lung disease (ILD) or pneumonitis that:
Was previous diagnosed and required systemic steroids, or
Is currently diagnosed and managed, or
Is suspected on radiologic imaging at screening
Known diffusing capacity of the lung for carbon monoxide (DLCO) \< 50%
Any Grade greater than or equal to (≥) 3 pulmonary disease unrelated to underlying malignancy
Pre-existing peripheral neuropathy Grade greater than or equal to (≥) 2
Uncontrolled diabetes mellitus
Prior therapy:
Prior treatment with antimicrotubule agents (taxanes, vinca alkaloids, or MMAEs) in the locally advanced, unresectable/refractory, or metastatic setting
Prior antimicrotubule agent exposure in curative settings (including adjuvant, neoadjuvant, or chemoradiotherapy) is permissible.
Received more than 1 prior line of cytotoxic chemotherapy in the locally advanced, unresectable/refractory, or metastatic setting
Prior cytotoxic chemotherapy in curative settings is permissible
At least 14 days must have elapsed from the last dose of radiotherapy until Cycle 1 Day 1.
Prior radiation therapy to the lung parenchyma that is \>30 Gray (Gy) within 6 months of Cycle 1 Day 1.
Any systemic anticancer therapy (standard or experimental) within 21 days prior to Cycle 1 Day 1.
Active central nervous system (CNS) lesions, including leptomeningeal metastasis, are excluded. Participants with definitively treated brain metastases are eligible in they meet the following criteria:
Have been clinically stable for at least 4 weeks prior to treatment initiation and baseline scans show no evidence of new or enlarged metastasis
On a stable dose of less than or equal to (≤) 10mg/day of prednisone or equivalent for a least 2 weeks (if requiring steroid treatment)
Treatment with corticosteroids greater than (\>) 1 month prior to Screening visit
No evidence of clinical and radiographic disease progression in the CNS for ≥ 21 days after definitive radiotherapy and/or surgery

Ubicaciones

Instituto de Investigaciones Clinicas de Mar del Plata

Mar del Plata, Buenos Aires, Argentina

CEMAIC - Centro Medico Privado

Córdoba, Cundinamarca, Argentina

Sanatorio Parque

Rosario, Santa Fe Province, Argentina

Hospital Provincial del Centenario

Rosario, Santa Fe Province, Argentina

Sanatorio Allende Cerro

Córdoba, Argentina

Centro Oncologico de Excelencia

San Juan, Argentina

Estudio aleatorizado, de fase 3, abierto, para evaluar sigvotatug vedotin en comparación con docetaxel en participantes adultos con cáncer de pulmón de células no pequeñas previamente tratado (Be6A Lung-01)