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NCT06586801

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

Sponsor: Shanghai East Hospital

View on ClinicalTrials.gov

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.

Official title: A Multicenter Prospective Cohort Study of the Patient-Reported Outcomes in ALK Positive Advanced Non-Small Cell Lung Cancer (NSCLC) in China

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

800

Start Date

2024-09-20

Completion Date

2026-09-30

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

OTHER

Patient-reported outcome

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. The first collection of the information in questionnaires (EORTC QLQ-C30, EORTC QLQ-LC13, PRO-CTCAE \[select items\]), which defined as baseline- PROs, will be completed at Cycle 1, Day 1±7days prior to administration of study drug; then the rest times of collection will be completed at every two treatment cycle prior to administration of study drug (i.e., on Cycle 3, Day 1±7days; Cycle 5, Day 1±7days; Cycle 7, Day 1±7days; Cycle 9, Day 1±7days; Cycle 11, Day 1±7days; Cycle 13, Day 1±7days) . EORTC-IL46 will be completed at Cycle 3, Day 1±7days (baseline) prior to administration of study drug; then at every other study treatment cycle prior to administration of study drug (i.e., on Cycle 5, Day 1±7days; Cycle 7, Day 1±7days; Cycle 9, Day 1±7days; Cycle 11, Day 1±7days; Cycle 13, Day 1±7days)