Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients

Inclusion Criteria:

1. Voluntary participation in this clinical study, understanding of study procedures, andability to sign written informed consent.
2. Age ≥18 years.
3. Locally advanced or metastatic (inoperable stage IIIa or IIIb-IV) NSCLC with diseasestaging according to the American Joint Committee on Cancer (AJCC)/UICC 8th editionlung cancer staging criteria.ALK fusion mutations confirmed by tumor histology orhematology.
4. Expected survival greater than 12 weeks.
5. Adequate bone marrow reserve, organ function, and coagulation as assessed by theinvestigator as evidenced by complete blood count, biochemical parameters in blood andurine, 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 contraceptionand should not breastfeed within 6 months from signing the main informed consent toefficacy evaluation/end of medication (whichever is later); Male patients were willingto use barrier contraception (i.e., condom) for 6 months from signing the maininformed consent until the efficacy assessment/end of medication, whichever occurredlater.
8. Female patients have a negative blood pregnancy test within 3 days before enrollmentor 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 12months after cessation of all exogenous hormone replacement therapy; b. Females lessthan 50 years of age may also be considered postmenopausal if they have beenamenorrhoeic for 12 months or more after cessation of all exogenous hormonal therapyand have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels withinthe laboratory postmenopausal reference values; c. History of irreversiblesterilization, including hysterectomy, bilateral oophorectomy, or bilateralsalpingectomy, except for bilateral tubal ligation.

Exclusion Criteria:

1. Use of strong CYP3A4 inhibitors, strong inducers, or drugs with a narrow therapeuticwindow that are sensitive substrates of CYP3A4 within 7 days and need to continuetreatment with these drugs during the study.
2. Patients with known active infectious diseases, such as active hepatitis B or C or HIVinfection of human immunodeficiency virus, active hepatitis B and C includinghepatitis B or C surface antigen (+) patients receiving intravenous treatment forinfection - patients receiving oral antiviral suppression of hepatitis B or C will beallowed to participate in the study.
3. Any other disease, metabolic abnormality, physical examination abnormality, orlaboratory abnormality that, in the judgment of the investigator, has reason tosuspect that the patient has a disease or condition that is not appropriate for theuse of lorlatinib, or would affect the interpretation of the study results, or placethe patient at high risk.
4. Female patients who are pregnant, breastfeeding, or plan to become pregnant during thestudy.
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 compliancewith the study procedures and requirements.