NCT06361589

Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients

Real World Study of Lolatinib for Patients With Advanced/Metastatic Anaplastic Lymphoma Kinase (ALK) - Positive Non-Small Cell Lung Cancer (NSCLC)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Sichuan Cancer Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was a multicenter, prospective, non-interventional clinical study that included first-line and late-line patients with advanced non-small cell lung cancer with ALK fusions treated with the third generation ALK-TKI lorlatinib until disease progression, intolerable toxicity, investigator or subject decision to withdraw, lost to follow-up, initiation of other antineoplastic therapy, or death. Clinical pathology including sex, age, ALK mutation status at diagnosis, and clinical stage at diagnosis were collected from medical records. Physical condition as assessed by ECOG-PS before administration of lorlatinib was also recorded. Treatment information was obtained from the records, including dose and timing of ALK-TKI therapy and tumor response, number of prior systemic lines of therapy, and local treatment modalities such as radiotherapy and surgery. Quality of life based on the EORTC QLQ C30+LC29 scale (plus the EORTC QLQ BN20 scale in patients with brain/meningeal metastases) was performed at baseline and at each follow-up point. This study will use REDCap platform to collect and manage the study data information of multi-center patients.

Conditions

• ALK-positive Non-small Cell Lung Cancer
• Real World Study

Interventions

Type	Name	Description
DRUG	Lorlatinib	lolatinib 100mg qd po

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-11-01
• Completion: 2028-11-01
• First posted: 2024-04-12
• Last updated: 2024-04-12

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study