RecruitingNCT06361589

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)


Sponsor

Sichuan Cancer Hospital and Research Institute

Enrollment

200 participants

Start Date

May 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a real-world study tracking how well lorlatinib — a targeted therapy for non-small cell lung cancer (NSCLC) with an ALK gene mutation — works outside of a controlled clinical trial setting. It collects data from actual clinical practice to understand outcomes, safety, and resistance patterns. **You may be eligible if...** - You are 18 or older - You have locally advanced or metastatic NSCLC (Stage IIIa or higher) - Your tumor has been confirmed to have an ALK fusion mutation - Your life expectancy is greater than 12 weeks - You have adequate blood counts and organ function - You are willing to provide written informed consent **You may NOT be eligible if...** - You do not have a confirmed ALK fusion mutation - You have serious heart problems (e.g., clinically significant bradycardia — an abnormally slow heart rate) - You have active CNS (brain or spinal cord) disease that is not stable - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLorlatinib

lolatinib 100mg qd po


Locations(1)

Sichuan cancer hospital

Chengdu, Sichuan, China

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NCT06361589


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