About this trial
The project is a Phase III, randomized, open-label, multicenter study in which approximately 36 patients with unresectable Stage III ALK positive Lung Adenocarcinoma will be randomized 1:1 to receive lorlatinib or concurrent/sequential platinum-based chemoradiotherapy
Eligibility criteria
Qualifiers
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.
Disqualifiers
Previously received any ALK-TKIs or any thoracic radiotherapy
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
Inadequate bone marrow reserve or organ function.
Trial design
Treatments tested in this trial
- lorlatinib
- concurrent/sequential platinum-based chemoradiotherapy