Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT06586801

Aún no recluta

The Patient-Reported Outcomes in ALK Positive Advanced NSCLC in China

Observacional

Fase no especificada

Patrocinador: Shanghai East Hospital

Última actualización: 19 de septiembre de 2024
Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.

This is a multicenter, prospective, longitudinal observational study designed to evaluate the patient-reported outcomes and safety profiles of patients with ALK positive advanced Non-Small Cell Lung Cancer (NSCLC) who received ALK-TKIs as first-line treatment.

Approximately 800 patients with ALK-positive locally advanced or metastatic NSCLC will be enrolled in this study. This study has 3 parallel cohorts which are listed below.

Patient-reported outcome data will be collected using the following instruments: EORTC QLQ-C30, EORTC QLQ-LC13, selected items from the PRO-CTCAE, EORTC-IL46.

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Categoría de tratamiento

Otros

Erforderliche Mutationen

ALK

Ensayo iniciado

20 de septiembre de 2024

Última actualización por el patrocinador

19 de septiembre de 2024

Finalización estimada

10 de mayo de 2025

Contacto del estudio

Nombre:Fei Zhou

Correo electrónico:story185@126.com

Teléfono:13801751704

Elegibilidad

Criterios de inclusión

* Have signed the informed consent form (ICF) as per local regulations

* Female or male aged 18 years or older

* Ability to comply with the study protocol, in the judgment of the investigator

* Life expectancy ≥ 12 weeks

* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2

* Have a confirmed diagnosis of locally advanced or metastatic NSCLC on or after the date of local approval for ALK-TKIs as first-line monotherapy regimen for ALK-positive advanced NSCLC and planned to receive treatment as per routine for at least one cycle (28 days) while on study

* ALK positive as determined by Ventana immunohistochemistry (IHC), fluorescent in situ hybridization (FISH), reverse transcription polymerase chain reaction(RT-PCR) and next generation sequencing (NGS), documented prior to receiving treatment with an ALK inhibitor

* Planned to receive, treatment for ALK-positive advanced NSCLC with ALK-TKIs

* Able to be followed up at the participating site

* Patients with advanced NSCLC who have asymptomatic central nervous system (CNS) metastases are eligible for inclusion

Criterios de exclusión

* Patients receiving ALK-TKIs as investigational study drugs in a clinical trial for the treatment of advanced NSCLC

* Patients participating in clinical trials within 28 days prior to initiation of study treatment

* Pregnant, lactating, or breastfeeding women

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Detalles del diseño

AsignaciónN/A

Modelo de intervenciónN/A

EnmascaramientoN/A

Número a inscribir800

Brazos e Intervenciones

Brazos

Intervenciones

Tipo:

Descripción: 400 ALK-positive locally advanced or metastatic NSCLC patients who are treated with Alectinib

Intervenciones:

Patient-reported outcome

Medidas de resultado

Medidas de resultado primarias

EORTC QLQ-LC13The data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.

Proportion of patients reporting clinically meaningful deterioration (decrease from baseline of ≥10 points) in the subscales of EORTC QLQ-LC13 (fatigue, chest pain) ;Change from baseline score (by 2 cycles) in the subscales of EORTC QLQ-LC13 (fatigue, chest pain) .

EORTC QLQ-C30The data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.

Proportion of patients reporting clinically meaningful deterioration (decrease from baseline of ≥ 10 points) in the subscales of QLQ-C30 (cognitive, physical and role functioning);Change from baseline score (by 2 cycles) in the subscales of QLQ-C30 (cognitive, physical and role functioning).

NCI PRO-CTCAEThe data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.

Presence, frequency of occurrence, severity, and/or degree of interference with daily function of symptomatic treatment toxicities (swelling, rash, blurred vision, anxious, sad) as assessed through use of the NCI PRO-CTCAE.

EORTC Item List (IL46)The data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.

Frequency of patients' response of the degree they are troubled with treatment symptoms, as assessed through use of the Protocol ML44840, Version 2.0 single-item EORTC Item List (IL46)

Medidas de resultado secundarias

To evaluate the safety of ALK-TKIs as first-line treatment in advanced ALK+ NSCLCThe data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.

Incidence and severity of adverse events, based on the NCI CTCAE v5.0.

To evaluate the tolerability of ALK-TKIs as first-line treatment in advanced ALK+ NSCLCThe data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.

ALK-TKIs treatment changes (dose modifications and/or discontinuation of treatment) and the rationale for treatment changes.

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