NCT06652555Not yet recruiting
The Incidence and Risk Factors of Central Nervous System Adverse Events of Lorlatinib in Patients with ALK-positive Advanced Non-small Cell Lung Cancer: a Real-world Study
The CNS AE of Lorlatinib in Patients with ALK-positive Advanced NSCLC
Source: ClinicalTrials.gov · Last updated 22 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 29 Sept 2024
- Start date
- 30 Oct 2024
- Primary completion date
- 29 Sept 2026
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Diseases
- Lung cancer
- NCT number
- NCT06652555
What you commit to
- Study type: Observational
- Planned participants: 100
- From 30 Oct 2024 to the primary completion date, 29 Sept 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- combined with other malignant tumors and received other anti-tumor therapy during the treatment of Lorlatinib
Other illness
- evidence of any severe or uncontrolled systemic illness, including uncontrolled hypertension and active bleeding, active infections including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
Who the study is looking for
- Patients with locally advanced (stage IIIb/IIIc), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy/chemotherapy, according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
- ALK-positive and the test results were based on RT-PCR /FISH /IHC /NGS methods in the laboratory department or testing institution of the hospital
- receiving targeted therapy with Lorlatinib
- age ≥18 years old
- follow-up after receipt of Lorlatinib
- voluntarily participate in the study and sign informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.