RecruitingPhase 2NCT06092086

Lorlatinib as the First-line Treatment in China Advanced ALK+ NSCLC

A Patient-Centric, Open-Label, Multicenter, Phase II Study of Lorlatinib Monotherapy in The First-Line Treatment of Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer


Sponsor

Guangdong Association of Clinical Trials

Enrollment

126 participants

Start Date

Aug 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II study is aim to investigate the efficacy, resistance mechanism, safety profile of first-line lorlatinib in China advanced ALK+ non-small cell lung cancer (NSCLC). Participants will receive continuous daily PO dosing of lorlatinib 100mg QD.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how well lorlatinib works as a first-line treatment for patients in China with advanced non-small cell lung cancer (NSCLC) whose tumors have a specific genetic change called an ALK-positive mutation. Lorlatinib is a targeted therapy designed specifically for this type of lung cancer. **You may be eligible if...** - You have been diagnosed with stage IIIB/C or stage IV non-small cell lung cancer - Your tumor has tested positive for the ALK mutation (confirmed by an approved test) - You have at least one measurable tumor outside the brain on imaging - You have not previously received ALK-targeted therapy - You are in reasonably good health **You may NOT be eligible if...** - You have already been treated with lorlatinib or another ALK inhibitor - You have uncontrolled brain metastases - You have significant heart, liver, or other organ problems - 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

DRUGLoratinib

Continuous daily PO dosing of lorlatinib 100mg QD.


Locations(1)

Guangdong Provincial Perople's Hospital

Guangzhou, Guangdong, China

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NCT06092086


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