癌研連線CancerLink
進行中（不再收案） NCT03052608

Lorlatinib 對比 Crizotinib 用於 ALK 陽性 NSCLC 患者第一線治療的研究

非小細胞肺癌子宮頸癌／婦癌前列腺癌淋巴瘤黑色素瘤甲狀腺癌Phase IIIIII 期IV 期ALK

一項第三期研究，旨在證明 Lorlatinib 單藥治療相比單獨使用 Crizotinib 能否延長未接受過治療的晚期 ALK 陽性 NSCLC 患者的無惡化存活期，並在同一人群中比較 Lorlatinib 與 Crizotinib 的整體存活期。

適應症：Carcinoma, Non-Small-Cell Lung

收案條件

納入條件

  • Histologically or cytologically confirmed diagnosis of locally advanced or metastatic ALK-positive NSCLC; at least 1 extracranial measurable target lesion not previously irradiated. CNS metastases allowed if asymptomatic and not currently requiring corticosteroid treatment.
  • Availability of an archival FFPE tissue specimen.
  • No prior systemic NSCLC treatment.
  • ECOG PS 0, 1, or 2.
  • Age ≥18 years .
  • Adequate Bone Marrow, Liver, Renal, Pancreatic Function
  • Negative pregnancy test for females of childbearing potential

排除條件

  • Spinal cord compression unless good pain control attained
  • Major surgery within 4 weeks prior to randomization.
  • Radiation therapy within 2 weeks prior to randomization, including stereotactic or partial brain irradiation. Whole brain irradiation within 4 weeks prior to randomization
  • Active bacterial, fungal, or viral infection
  • Clinically significant cardiovascular disease, active or within 3 months prior to enrollment. Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation, bradycardia or congenital long QT syndrome
  • Predisposing characteristics for acute pancreatitis in the last month prior to randomization.
  • History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease
  • Active malignancy (other than NSCLC, non melanoma skin cancer, in situ cervical cancer, papillary thyroid cancer, LCIS/DCIS of the breast, or localized prostate cancer) within the last 3 years prior to randomization.
  • Concurrent use of any of the following food or drugs within 12 days prior to the first dose of lorlatinib or crizotinib.
  • known strong CYP3A inhibitors .
  • known strong CYP3A inducers
  • known P gp substrates with a narrow therapeutic index
  • Concurrent use of CYP3A substrates with narrow therapeutic indices within 12 days prior to the first dose of lorlatinib or crizotinib.
  • Other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study results
  • Investigational site staff members directly involved in the conduct of the study and their family members, or Pfizer employees, including their family members, directly involved in the conduct of the study.
  • Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation.

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。