Clinical Trial

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

Not Yet Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated September 19, 2024 (before its estimated May 10, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-04.
Trial Details
NCT Number NCT06586801
Lead Sponsor Shanghai East Hospital
Collaborators: Zhejiang Cancer Hospital, Henan Cancer Hospital
Conditions Non-small Cell Lung Cancer
Enrollment 800 participants
Start Date 2024-09-20
Primary Completion 2025-05-10 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2024-09-19