An observational study in ALK and NSCLC, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Observational
The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer.
The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer.
Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 149 studies on the registry; 91 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ALK-positive NSCLC
Exclusion Criteria:
Baseline characteristics and information during loratinib treatment were collected
Other: Group 1
without Intervention
Incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib in real world study.
The incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib will be reported, such as cognitive effects, mood effects, speech effects and psychotic effects.
Time frame: 2 year
To explore the optimized therapy management strategies for CNS AEs associated with lorlatinib in real-world study.
According to the data from CROWN study, management strategies such as to dose interruption, dose reduction or concurrent medication would minimize the impact of CNS AEs effects. However, the optimized therapy management strategies for CNS AEs associated with lorlatinib in real-world study of China needs to be further clarified.
Time frame: 1 year
Analysis of factors associated with developing CNS AEs related to lorlatinib treatment.
The association between baseline characteristics and CNS adverse effects will be evaluated. Baseline characteristics include age, gender, medical history, brain metastases at baseline, previous brain radiation, and lorlatinib treatment lines, among others.
Time frame: 1 year
Correlation analysis between CNS AEs occurrence and anti-tumor efficacy
Landmark analysis will be used to investigate the possible association between development of CNS AEs within 24 weeks of initiating lorlatinib and progression-free survival (PFS) as well as the objective response rate (ORR).
Time frame: 24 weeks
No study locations are listed for this record.
Plan to share: Yes — research article
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Shanghai Pulmonary Hospital, Shanghai, China