Lorlatinib Compared with Concurrent/ Sequential Chemoradiotherapy in Stage III ALK Positive Lung Adenocarcinoma

Prior treatment

• Previously received any ALK-TKIs or any thoracic radiotherapy
• Pregnant female patients; breastfeeding female patients; fertile male patients and female patients of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 97 days, if male or 35 days if female, after the last dose of investigational product under lorlatinib.
• Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation.

Other illness

• Active infection, including Bacteria, fungi or viruses
• Any evidence of severe or uncontrolled systemic diseases, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol
• History of interstitial lung disease (ILD) or active ILD or pneumonia

Lab values

• Inadequate bone marrow reserve or organ function.
  • Absolute neutrophil count \<1.5\*109/L
  • Platelet count \<90\*109/L
  • Hemoglobin \<90 g/L (\<9 g/dL) d Alanine aminotransferase \> 3 times the upper limit of normal (ULN)
  • Aspartate aminotransferase \> 3 times the upper limit of normal (ULN) f. Total bilirubin \> 1.5\*ULN g. Creatinine \>1.5\*ULN or creatinine clearance \<45 mL/min (calculated by Cockcroft-Gault formula)

Other

• Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements

• Study Population: Patients with histologically or cytologically confirmed diagnosis of ALK-positive, lung adenocarcinoma who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the International Association for the Study of Lung Cancer \[IASLC\]).
• Tumor Requirements: At least 1 measurable target lesion per RECIST v. 1.1
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1. Life expectancy at least 12weeks at Day1.
• Age ≥18 years.
• Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.