Actively Recruiting
Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients
Led by Sichuan Cancer Hospital and Research Institute · Updated on 2024-04-12
200
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was a multicenter, prospective, non-interventional clinical study that included first-line and late-line patients with advanced non-small cell lung cancer with ALK fusions treated with the third generation ALK-TKI lorlatinib until disease progression, intolerable toxicity, investigator or subject decision to withdraw, lost to follow-up, initiation of other antineoplastic therapy, or death. Clinical pathology including sex, age, ALK mutation status at diagnosis, and clinical stage at diagnosis were collected from medical records. Physical condition as assessed by ECOG-PS before administration of lorlatinib was also recorded. Treatment information was obtained from the records, including dose and timing of ALK-TKI therapy and tumor response, number of prior systemic lines of therapy, and local treatment modalities such as radiotherapy and surgery. Quality of life based on the EORTC QLQ C30+LC29 scale (plus the EORTC QLQ BN20 scale in patients with brain/meningeal metastases) was performed at baseline and at each follow-up point. This study will use REDCap platform to collect and manage the study data information of multi-center patients.
CONDITIONS
Official Title
Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and able to sign informed consent
- Age 18 years or older
- Diagnosed with locally advanced or metastatic (inoperable stage IIIa or IIIb-IV) NSCLC with ALK fusion mutations confirmed by tumor histology or hematology
- Expected survival longer than 12 weeks
- Adequate bone marrow, organ function, coagulation, and heart health based on tests
- Able to take oral medication
- Women of childbearing potential agree to use contraception and not breastfeed for 6 months after consent until end of treatment
- Women must have a negative pregnancy test before enrollment or meet criteria confirming no risk of pregnancy (postmenopause, amenorrhea with hormone levels, or irreversible sterilization)
- Men agree to use barrier contraception for 6 months after consent until end of treatment
You will not qualify if you...
- Use of strong CYP3A4 inhibitors, inducers, or sensitive CYP3A4 substrate drugs within 7 days that must continue during study
- Active infectious diseases like hepatitis B or C or HIV; patients on oral antiviral suppression allowed
- Other diseases, abnormalities, or conditions that make lorlatinib use unsafe or affect study results
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- Known allergy to lorlatinib or its ingredients
- Any patient judged to have poor compliance with study procedures by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sichuan cancer hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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