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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Baseline characteristics and information during loratinib treatment were collected |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1 | Other | without Intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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ALK-positive NSCLC
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Wang, Doctor | Contact | 18170211997 | leewang8023@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunxia Su, Doctor | Shanghai Pulmonary Hospital, Shanghai, China | Study Chair |
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research article
up to 36 month
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| 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. | 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). | 24 weeks |