Actively Recruiting
Real World Study of Lorlatinib for Patients With Advanced or Metastatic ALK-Positive Non-Small Cell Lung Cancer
Led by Sichuan Cancer Hospital and Research Institute · Updated on 2024-04-12
200
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has ALK gene fusions. This observational study collects real-world data from patients treated with the third-generation ALK inhibitor lorlatinib as either a first or later line of therapy. The goal is to track disease progression, side effects, and quality of life over time to better understand treatment outcomes in this patient group. Participants receive lorlatinib orally at a dose of 100 mg once daily and continue treatment until disease progression, unacceptable side effects, withdrawal, or other clinical reasons. The study uses a multicenter approach and collects detailed clinical and treatment information from medical records. Quality of life is assessed regularly using standardized questionnaires, including measures specific to lung cancer and brain metastases. During the study, researchers gather data on tumor response, prior treatments, clinical stage, and physical condition. They monitor progression-free survival, overall survival, adverse events, and patient-reported outcomes for up to five years following the first dose. Data collection and management are supported by the REDCap platform, enabling ongoing assessment of treatment impact and safety in routine clinical practice.
CONDITIONS
Brief Title
Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent
- Age 18 years or older
- Locally advanced or metastatic NSCLC with ALK fusion mutations confirmed by tumor histology or hematology
- Expected survival greater than 12 weeks
- Adequate bone marrow, organ function, and coagulation as assessed by investigator
- Ability to take oral medication
- Female patients of childbearing potential agree to use contraception and not breastfeed during the study period
- Female patients have a negative pregnancy test or meet criteria for no risk of pregnancy
You will not qualify if you...
- Use of strong CYP3A4 inhibitors, inducers, or sensitive CYP3A4 substrates within 7 days requiring continued treatment
- Active infectious diseases such as active hepatitis B or C or HIV
- Other diseases or abnormalities that may affect study results or patient safety
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Hypersensitivity to lorlatinib or its ingredients
- Poor compliance with study procedures as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 5 years following the first dose
Participants receive lorlatinib, an oral medication, for advanced ALK-positive NSCLC.
Visits as per routine care during treatment period
Duration - Up to approximately 5 years following the first dose
Participants are monitored for progression-free survival, overall survival, adverse events, and patient-reported outcomes for up to 5 years after starting therapy.
Visits as per routine care during follow-up
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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