Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients

Launched by SICHUAN CANCER HOSPITAL AND RESEARCH INSTITUTE · Apr 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called lorlatinib in patients with advanced ALK-positive non-small cell lung cancer (NSCLC). The trial is open to adults aged 18 and older who have been diagnosed with locally advanced or metastatic NSCLC that has certain genetic changes known as ALK fusions. Participants need to be able to take medication by mouth and have an expected survival of more than 12 weeks. It’s important that they understand the study and voluntarily agree to participate.

During the trial, patients will receive lorlatinib until their cancer progresses or they experience side effects that are too severe, choose to stop treatment, or pass away. Researchers will collect information about the patients’ health and quality of life before starting the treatment and at follow-up visits. This trial is also looking to understand how lorlatinib affects patients in real-world settings, which means it focuses on how the treatment works outside of controlled clinical environments. If you or a loved one are considering participation, it’s a chance to contribute to important research that could help others with similar conditions.

Gender

ALL

Eligibility criteria

• 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.