NCT06092086

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Guangdong Association of Clinical Trials · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a patient-centric, two cohorts, open-label, multi-center, phase II study in China, designed to prospectively enroll 126 advanced ALK+NSCLC patients, including 84 subjects fulfilled CROWN criteria as "CROWN criteria (CC) cohort", and another 42 subjects beyond CROWN criteria as "compassionate use (CU) cohort". Subjects will receive continuous daily PO dosing of lorlatinib 100mg QD, from the date of first dosing until disease progression, unacceptable toxicity, or withdrawal for any reason, or death, whichever occurs first. The primary endpoints are progression-free survival (PFS) of CC cohort per investigator, and resistance mechanism of first-line lorlatinib. Secondary endpoints are 1/2/3-year PFS, cumulative rate of central nervous system (CNS) progression, intracranial-time to progression (IC-TTP), objective response rate (ORR) and intracranial ORR (IC-ORR), overall survival (OS), safety and PRO. Exploratory endpoints include evaluation of candidate biomarkers of sensitivity or resistance to lorlatinib, dynamic ctDNA change during treatment, and effective treatment after lorlatinib resistance.

Conditions

• ALK Positive Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Loratinib	Continuous daily PO dosing of lorlatinib 100mg QD.

Timeline

• Start date: 2023-08-18
• Primary completion: 2025-08-01
• Completion: 2030-08-01
• First posted: 2023-10-23
• Last updated: 2023-10-23

Locations

1 site across 1 country: China