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

NCT06586801 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

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)

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • Henan Cancer Hospital

    collaborator OTHER_GOV

  • Shanghai East Hospital

    lead OTHER

Principal Investigators

  • Caicun Zhou · Shanghai East Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-20
Primary Completion
2025-05-10
Completion
2026-09-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06586801 on ClinicalTrials.gov