Observational study of lorlatinib for advanced ALK-positive lung cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, non-interventional study focuses on patients with advanced non-small cell lung cancer (NSCLC) who have ALK fusions and are treated with lorlatinib. It includes both first-line and late-line patients, collecting data on clinical pathology, treatment history, and quality of life assessments. Patients will be monitored until disease progression, intolerable toxicity, or other specified withdrawal criteria are met. The study aims to gather real-world evidence on the effectiveness and safety of lorlatinib in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntary participation in this clinical study, understanding of study procedures, and ability to sign written informed consent.
2. Age ≥18 years.
3. Locally advanced or metastatic (inoperable stage IIIa or IIIb-IV) NSCLC with disease staging according to the American Joint Committee on Cancer (AJCC)/UICC 8th edition lung cancer staging criteria.ALK fusion mutations confirmed by tumor histology or hematology.
4. Expected survival greater than 12 weeks.
5. Adequate bone marrow reserve, organ function, and coagulation as assessed by the investigator as evidenced by complete blood count, biochemical parameters in blood and urine, coagulation, and electrocardiogram or cardiac ultrasound at baseline.
6. Can take the medicine orally and swallow it.
7. Female patients of childbearing potential are willing to use appropriate contraception and should not breastfeed within 6 months from signing the main informed consent to efficacy evaluation/end of medication (whichever is later); Male patients were willing to use barrier contraception (i.e., condom) for 6 months from signing the main informed consent until the efficacy assessment/end of medication, whichever occurred later.
8. Female patients have a negative blood pregnancy test within 3 days before enrollment or meet one of the following criteria to demonstrate no risk of pregnancy: a. Postmenopausal is defined as age 50 years or older and amenorrhea for at least 12 months after cessation of all exogenous hormone replacement therapy; b. Females less than 50 years of age may also be considered postmenopausal if they have been amenorrhoeic for 12 months or more after cessation of all exogenous hormonal therapy and have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels within the laboratory postmenopausal reference values; c. History of irreversible sterilization, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, except for bilateral tubal ligation.

Exclusion Criteria:

1. Use of strong CYP3A4 inhibitors, strong inducers, or drugs with a narrow therapeutic window that are sensitive substrates of CYP3A4 within 7 days and need to continue treatment with these drugs during the study.
2. Patients with known active infectious diseases, such as active hepatitis B or C or HIV infection of human immunodeficiency virus, active hepatitis B and C including hepatitis B or C surface antigen (+) patients receiving intravenous treatment for infection - patients receiving oral antiviral suppression of hepatitis B or C will be allowed to participate in the study.
3. Any other disease, metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the judgment of the investigator, has reason to suspect that the patient has a disease or condition that is not appropriate for the use of lorlatinib, or would affect the interpretation of the study results, or place the patient at high risk.
4. Female patients who are pregnant, breastfeeding, or plan to become pregnant during the study.
5. Patients with hypersensitivity to any active or inactive ingredient of lorlatinib.
6. Any other patient who, in the judgment of the investigator, may have poor compliance with the study procedures and requirements.

Where it's running

• Sichuan cancer hospital
  Chengdu, Sichuan, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Real-world first-line atezolizumab for stage IV NSCLC with PD-L1 ≥50% in Türkiye

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.