Induction Lorlatinib in Stage III Non-small Cell Lung Cancer

Status Recruiting

Clinical Trial Summary

A prospective, single-arm, open-label phase 2 study that evaluates the efficacy and safety of induction Lorlatinib in stage III non-small cell lung cancer and explores the clinical feasibility of dynamic ctDNA and multidisciplinary assessment in guiding local treatments.

Clinical Trial Description

Simon two-stage was applied to estimate the required sample size for the study. Overall an estimated 43 patients were required and at least 12 patients achieved pathological complete response would be deemed as positive result. Patients will be provided 3 cycles induction Lorlatinib 100mg and then assessed whether patients would be eligible for radical surgery or local radiotherapy through multidisciplinary evaluation. After local intervention, patients could choose consolidation treatment of Lorlatinib for up to 2 years or adjuvant doublet chemotherapy for up to 4 cycles. Dynamic blood samples will be collected before and after induction Lorlatinib as well as consolidation treatment. The primary endpoints is pCR for patients who received radical surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05740943
Study type	Interventional
Source	Guangdong Provincial People's Hospital
Contact	Wen-Zhao Zhong, MD.
Phone	86-13609777314
Email	13609777314@163.com
Status	Recruiting
Phase	Phase 2
Start date	March 15, 2023
Completion date	December 31, 2026

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